NDC 68016-038

Sore throat and cough lozenge

Mixed Berry

Sore throat and cough lozenge is a Oral Lozenge in the Human Otc Drug category. It is labeled and distributed by Premier Value. The primary component is Dextromethorphan Hydrobromide; Benzocaine.

Product ID68016-038_7899833e-32b8-1d75-e053-2991aa0a8691
NDC68016-038
Product TypeHuman Otc Drug
Proprietary NameSore throat and cough lozenge
Generic NameMixed Berry
Dosage FormLozenge
Route of AdministrationORAL
Marketing Start Date2015-07-28
Marketing End Date2019-08-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NamePremier Value
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; BENZOCAINE
Active Ingredient Strength5 mg/1; mg/1
NDC Exclude FlagN

Packaging

NDC 68016-038-18

18 LOZENGE in 1 BLISTER PACK (68016-038-18)
Marketing Start Date2015-07-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68016-038-18 [68016003818]

Sore throat and cough lozenge LOZENGE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-28
Marketing End Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/1

OpenFDA Data

SPL SET ID:464e48da-0aea-54be-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1039251

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