NDC | 59667-0075-2, 59667-0076-2, 59667-0077-2, 59667-0078-2, 59667-0079-2, 59667-0080-2, 59667-0081-2, 59667-0082-2, 59667-0083-2, 59667-0084-2, 59667-0085-2, 59667-0086-2, 59667-0087-2, 59667-0088-2 |
Set ID | 6487e3e4-2e2c-4383-aad6-277d156f363e |
Category | HUMAN OTC DRUG LABEL |
Packager | Home Sweet Homeopathics |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- PRINCIPAL DISPLAY PANEL
- PURPOSE
- INDICATIONS & USAGE
- Directions:
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- Active ingredients:
- Inactive Ingredients:
-
INGREDIENTS AND APPEARANCE
TANTRUMS AND WHINING
arsenicum 30c, belladonna 30c, calc phos 30c, chamomilla 30c, cina 30c, ignatia 30c, pulsatilla 30c, nat mur 30c, nux vomica 30c, thuja 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0075 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC ACID (UNII: N7CIZ75ZPN) (ARSENIC ACID - UNII:N7CIZ75ZPN) ARSENIC ACID 30 [hp_C] in 30 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 30 [hp_C] TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 30 [hp_C] in 30 [hp_C] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 30 [hp_C] in 30 [hp_C] ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 30 [hp_C] in 30 [hp_C] STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_C] in 30 [hp_C] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 30 [hp_C] in 30 [hp_C] SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_C] in 30 [hp_C] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_C] in 30 [hp_C] THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0075-2 30 [hp_C] in 1 BOTTLE, SPRAY 08/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 KICKING AND SCREAMING
apis 30c, anacardium 30c, belladonna 30c, borax 30c, calc phos 30c, chamomilla 30c, cina 30c, ipecac 30c, kali carb, lac can 30c, stramoniumn 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0076 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APIS MELLIFERA VENOM (UNII: 76013O881M) (APIS MELLIFERA VENOM - UNII:76013O881M) APIS MELLIFERA VENOM 30 [hp_C] in 30 [hp_C] SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE 30 [hp_C] in 30 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 30 [hp_C] SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE 30 [hp_C] in 30 [hp_C] TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 30 [hp_C] in 30 [hp_C] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 30 [hp_C] in 30 [hp_C] ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 30 [hp_C] in 30 [hp_C] IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 30 [hp_C] in 30 [hp_C] POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 30 [hp_C] in 30 [hp_C] CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT) CANIS LUPUS FAMILIARIS MILK 30 [hp_C] in 30 [hp_C] DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0076-2 30 [hp_C] in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 HAIR PULLING
arsenicum 30c, belladonna 30c, cina 30c, cuprum 30c, lillium 30c tarentula 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0077 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 30 [hp_C] in 30 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 30 [hp_C] ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 30 [hp_C] in 30 [hp_C] COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 30 [hp_C] in 30 [hp_C] LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917) (LILIUM LANCIFOLIUM FLOWERING TOP - UNII:6268MFA917) LILIUM LANCIFOLIUM FLOWERING TOP 30 [hp_C] in 30 [hp_C] LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0077-2 30 [hp_C] in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 PINCHING AND BITING
belladonna 30c, calc carb 30c, cantharis 30c, chamomilla 30c, coffea cruda 30c, cuprum 30c, lachesis 30c, hyoscyamus 30c, phytolacca 30c, stramonium 30c, veratrum 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0078 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 30 [hp_C] OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C] in 30 [hp_C] LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA 30 [hp_C] in 30 [hp_C] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 30 [hp_C] in 30 [hp_C] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 30 [hp_C] in 30 [hp_C] copper (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) copper 30 [hp_C] in 30 [hp_C] LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 30 [hp_C] in 30 [hp_C] HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 30 [hp_C] in 30 [hp_C] PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 30 [hp_C] in 30 [hp_C] DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 30 [hp_C] in 30 [hp_C] VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0078-2 30 [hp_C] in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 THROWING AND HITTING
belladonna 30c, colocynthis 30c dulcamara 30c, hyoscyamus 30c, lillium 30c, nux vomica 30c, staphysagria 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0079 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 30 [hp_C] CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 30 [hp_C] in 30 [hp_C] SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 30 [hp_C] in 30 [hp_C] HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 30 [hp_C] in 30 [hp_C] LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917) (LILIUM LANCIFOLIUM FLOWERING TOP - UNII:6268MFA917) LILIUM LANCIFOLIUM FLOWERING TOP 30 [hp_C] in 30 [hp_C] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_C] in 30 [hp_C] DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0079-2 30 [hp_C] in 1 BOTTLE, SPRAY 08/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 ATTENTION SPAN
aconite 30c, aesculus 30c, belladonna 30c, bovista 30c, hepar sulph 30c, hyoscyamus 30c, ignatia 30c, silicea 30c, sticta 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0080 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 30 [hp_C] in 30 [hp_C] AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER 30 [hp_C] in 30 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 30 [hp_C] GIANT PUFFBALL (UNII: I6839Y031A) (GIANT PUFFBALL - UNII:I6839Y031A) GIANT PUFFBALL 30 [hp_C] in 30 [hp_C] CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 30 [hp_C] in 30 [hp_C] HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 30 [hp_C] in 30 [hp_C] STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_C] in 30 [hp_C] SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 30 [hp_C] in 30 [hp_C] LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T) LOBARIA PULMONARIA 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0080-2 30 [hp_C] in 1 BOTTLE, SPRAY 08/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 SIBLING JEALOUSY
arsenicum 30c, calcarea carb 30c, chamomilla 30c, hyoscyamus 30c, ignatia 30c, lachesis 30c, pulsatilla 30c, sepia 30c, nux vomica 30c, natrum mur 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0081 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 30 [hp_C] in 30 [hp_C] OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C] in 30 [hp_C] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 30 [hp_C] in 30 [hp_C] HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 30 [hp_C] in 30 [hp_C] STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_C] in 30 [hp_C] LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 30 [hp_C] in 30 [hp_C] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 30 [hp_C] in 30 [hp_C] SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 30 [hp_C] in 30 [hp_C] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_C] in 30 [hp_C] SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0081-2 30 [hp_C] in 1 BOTTLE 08/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 LOUD CHILD
arnica 30c, belladonna 30c,hyoscyamus 30c, lachesis 30c, nux moschata 30c, silicea 30c, sepia 30c, stramonium 30c, sulphur 30c, veratrum album 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0082 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 30 [hp_C] in 30 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 30 [hp_C] HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 30 [hp_C] in 30 [hp_C] LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 30 [hp_C] in 30 [hp_C] NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG 30 [hp_C] in 30 [hp_C] SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 30 [hp_C] in 30 [hp_C] SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 30 [hp_C] in 30 [hp_C] DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 30 [hp_C] in 30 [hp_C] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 30 [hp_C] in 30 [hp_C] VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0082-2 30 [hp_C] in 1 BOTTLE, SPRAY 08/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 SPEECH THERAPY
agaricus 30c, belladonna 30c, hyoscyamus 30c, kali brom 30c, natrum mur 30c, nux vomica 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0083 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY 30 [hp_C] in 30 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 30 [hp_C] HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 30 [hp_C] in 30 [hp_C] POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 30 [hp_C] in 30 [hp_C] SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_C] in 30 [hp_C] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0083-2 30 [hp_C] in 1 BOTTLE, SPRAY 08/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 GROWING PAINS
calc carb 30c, calc phos 30c, eupatorium 30c, guaicum 30c, phosphoricum acidum 30c, ruta grav 30c, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0084 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C] in 30 [hp_C] CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 30 [hp_C] in 30 [hp_C] EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 30 [hp_C] in 30 [hp_C] GUAIAC (UNII: 03C8A0DFJ8) (GUAIAC - UNII:03C8A0DFJ8) GUAIAC 30 [hp_C] in 30 [hp_C] PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 30 [hp_C] in 30 [hp_C] RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0084-2 30 [hp_C] in 1 BOTTLE, SPRAY 08/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 HYPERSENSITIVITY
aconite 30c, aurum nat mur 30c, belladonna 30c, chamomilla 30c, gelseium 30c, kali phos 30c, phosphorous, pulsatilla 30c, staphysagria 30, teucrium 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0085 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 30 [hp_C] in 30 [hp_C] SODIUM TETRACHLOROAURATE (UNII: 7FT6QUT299) (TETRACHLOROAURATE ION - UNII:ZNL6IP5PJX) SODIUM TETRACHLOROAURATE 30 [hp_C] in 30 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 30 [hp_C] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 30 [hp_C] in 30 [hp_C] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C] in 30 [hp_C] POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 30 [hp_C] in 30 [hp_C] PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_C] in 30 [hp_C] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 30 [hp_C] in 30 [hp_C] DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 30 [hp_C] in 30 [hp_C] TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA) TEUCRIUM MARUM 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0085-2 30 [hp_C] in 1 BOTTLE, SPRAY 08/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 PEEPSING
argentum 30c, belladonna 30c, causticum 30c, cina 30c, equisetum 30c, kreosotum 30c, lycopodium 30c, nux vomica 30c, sepia 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0086 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 30 [hp_C] in 30 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 30 [hp_C] CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 30 [hp_C] in 30 [hp_C] ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 30 [hp_C] in 30 [hp_C] EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE 30 [hp_C] in 30 [hp_C] WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE 30 [hp_C] in 30 [hp_C] LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 30 [hp_C] in 30 [hp_C] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_C] in 30 [hp_C] SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0086-2 30 [hp_C] in 1 BOTTLE, SPRAY 08/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 NIGHT TERRORS
borax 30c, calc carb 30c, capsicum 30c, chamomilla 30c, cina 30c, lac can 30c, kali bromatum 30c, stramonium 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0087 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE 30 [hp_C] in 30 [hp_C] OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C] in 30 [hp_C] CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 30 [hp_C] in 30 [hp_C] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 30 [hp_C] in 30 [hp_C] ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 30 [hp_C] in 30 [hp_C] CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT) CANIS LUPUS FAMILIARIS MILK 30 [hp_C] in 30 [hp_C] POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 30 [hp_C] in 30 [hp_C] DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0087-2 30 [hp_C] in 1 BOTTLE, SPRAY 08/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 NIGHTY NIGHT
argentum 30c, arsenicum 30c, belladonna 30c, calc phos 30c, chelidonium 30c, coffea 30c, lillium 30c, podophyllum 30c pulsatilla 30c, rhus tox 30c sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59667-0088 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 30 [hp_C] in 30 [hp_C] ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 30 [hp_C] in 30 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 30 [hp_C] in 30 [hp_C] TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 30 [hp_C] in 30 [hp_C] CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 30 [hp_C] in 30 [hp_C] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 30 [hp_C] in 30 [hp_C] LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI) LILIUM LANCIFOLIUM WHOLE FLOWERING 30 [hp_C] in 30 [hp_C] PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM 30 [hp_C] in 30 [hp_C] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 30 [hp_C] in 30 [hp_C] TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 30 [hp_C] in 30 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59667-0088-2 30 [hp_C] in 1 BOTTLE, SPRAY 08/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/02/2013 Labeler - Home Sweet Homeopathics (078883277) Establishment Name Address ID/FEI Business Operations Nichole Michelle Langham 078883277 manufacture(59667-0075, 59667-0076, 59667-0077, 59667-0078, 59667-0079, 59667-0080, 59667-0081, 59667-0082, 59667-0083, 59667-0084, 59667-0085, 59667-0086, 59667-0087, 59667-0088) , label(59667-0075, 59667-0076, 59667-0077, 59667-0078, 59667-0079, 59667-0080, 59667-0081, 59667-0082, 59667-0083, 59667-0084, 59667-0085, 59667-0086, 59667-0087, 59667-0088) , pack(59667-0075, 59667-0076, 59667-0077, 59667-0078, 59667-0079, 59667-0080, 59667-0081, 59667-0082, 59667-0083, 59667-0084, 59667-0085, 59667-0086, 59667-0087, 59667-0088)