NDC 68016-708

COUGH Nighttime Cough Relief

Dextromethorphan Hbr And Doxylamine Succinate

COUGH Nighttime Cough Relief is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Chain Drug Consortium, Llc. The primary component is Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID68016-708_b54ee78f-7b07-494c-947f-e4609fea9618
NDC68016-708
Product TypeHuman Otc Drug
Proprietary NameCOUGH Nighttime Cough Relief
Generic NameDextromethorphan Hbr And Doxylamine Succinate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-07-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameChain Drug Consortium, LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength30 mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68016-708-08

236 mL in 1 BOTTLE (68016-708-08)
Marketing Start Date2015-07-27
Marketing End Date2021-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68016-708-08 [68016070808]

COUGH Nighttime Cough Relief SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-27

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL

OpenFDA Data

SPL SET ID:7158d25e-b2da-4fac-b9ec-3c13132c4b8f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1234386
  • NDC Crossover Matching brand name "COUGH Nighttime Cough Relief" or generic name "Dextromethorphan Hbr And Doxylamine Succinate"

    NDCBrand NameGeneric Name
    68016-708COUGH Nighttime Cough ReliefDextromethorphan HBr and Doxylamine succinate
    58602-132AuroQuil Cough Nighttime Cough ReliefDextromethorphan HBr and Doxylamine succinate

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