NDC | 12546-109-14, 12546-109-16, 12546-109-18, 12546-109-30, 12546-109-40, 12546-109-80, 12546-109-89, 12546-109-96, 12546-109-99 |
Set ID | 5f4af8e8-8550-45c7-a199-694efac9e7be |
Category | HUMAN OTC DRUG LABEL |
Packager | Mondelez Global LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- Active Ingredient
- Purposes
- Uses
- Warnings
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions
- OTC Principal Display Panel
-
INGREDIENTS AND APPEARANCE
HALLS CHERRY
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-109 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.8 mg Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Product Characteristics Color red (RED) Score no score Shape OVAL Size 21mm Flavor CHERRY (CHERRY) Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12546-109-18 18 in 1 BAG; Type 0: Not a Combination Product 03/31/2019 2 NDC:12546-109-30 30 in 1 BAG; Type 0: Not a Combination Product 03/31/2019 3 NDC:12546-109-24 24 in 1 BAG; Type 0: Not a Combination Product 12/02/2019 4 NDC:12546-109-40 40 in 1 BAG; Type 0: Not a Combination Product 03/31/2019 5 NDC:12546-109-80 80 in 1 BAG; Type 0: Not a Combination Product 03/31/2019 6 NDC:12546-109-89 200 in 1 BAG; Type 0: Not a Combination Product 03/31/2019 7 NDC:12546-109-16 16 in 1 BAG; Type 0: Not a Combination Product 03/31/2019 8 NDC:12546-109-96 96 in 1 BAG; Type 0: Not a Combination Product 03/31/2019 9 NDC:12546-109-14 14 in 1 BAG; Type 0: Not a Combination Product 03/31/2019 10 NDC:12546-109-99 160 in 1 PACKAGE; Type 0: Not a Combination Product 03/31/2019 11 NDC:12546-109-01 100000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 12/02/2019 12 NDC:12546-109-02 150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 12/02/2019 13 NDC:12546-109-03 2400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 12/02/2019 14 NDC:12546-109-04 720 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 12/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/31/2019 Labeler - Mondelez Global LLC (050964956) Establishment Name Address ID/FEI Business Operations MSI Express, Inc. 117973852 pack(12546-109)