Label: HALLS STRAWBERRY- menthol lozenge
- NDC Code(s): 12546-114-30, 12546-114-40, 12546-114-80
- Packager: Mondelez Global LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated March 20, 2023
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- Active Ingredient
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INGREDIENTS AND APPEARANCE
HALLS STRAWBERRY
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-114 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.7 mg Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C RED NO. 40 (UNII: WZB9127XOA) POTASSIUM CITRATE (UNII: EE90ONI6FF) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Product Characteristics Color red (light red) Score no score Shape OVAL Size 21mm Flavor STRAWBERRY (Strawberry) Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12546-114-30 30 in 1 BAG; Type 0: Not a Combination Product 07/14/2019 2 NDC:12546-114-40 40 in 1 BAG; Type 0: Not a Combination Product 07/14/2019 03/21/2023 3 NDC:12546-114-80 80 in 1 BAG; Type 0: Not a Combination Product 07/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/14/2019 Labeler - Mondelez Global LLC (050964956) Establishment Name Address ID/FEI Business Operations Mondelez Canada Inc. 246791201 manufacture(12546-114)