NDC 68016-710

COLD and FLU Nighttime Relief

Acetaminophen, Doxylamine Succinate, And Dextromethorphan Hbr

COLD and FLU Nighttime 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 Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID68016-710_468009a3-b74d-4a0c-acec-8e90ab1a46dd
NDC68016-710
Product TypeHuman Otc Drug
Proprietary NameCOLD and FLU Nighttime Relief
Generic NameAcetaminophen, Doxylamine Succinate, And Dextromethorphan Hbr
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 NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68016-710-08

237 mL in 1 BOTTLE (68016-710-08)
Marketing Start Date2015-07-27
Marketing End Date2021-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68016-710-08 [68016071008]

COLD and FLU Nighttime Relief SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-27

NDC 68016-710-12 [68016071012]

COLD and FLU Nighttime Relief SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-27

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:ee8a658a-3183-4ff6-9d8b-a04f99d82371
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043400
  • NDC Crossover Matching brand name "COLD and FLU Nighttime Relief" or generic name "Acetaminophen, Doxylamine Succinate, And Dextromethorphan Hbr"

    NDCBrand NameGeneric Name
    50844-252Cold and Flu Nighttime ReliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    50844-266Cold and Flu Nighttime ReliefAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    50844-793Cold and Flu Nighttime ReliefAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    55315-357COLD and FLU Nighttime ReliefAcetaminophen, Doxylamine succinate, and Dextromethorphan HBr
    55315-358COLD and FLU Nighttime ReliefAcetaminophen, Doxylamine succinate, and Dextromethorphan HBr
    58602-508Cold and Flu Nighttime Reliefacetaminophen, doxylamine succinate, and dextromethorphan hbr solution
    68016-707COLD and FLU Nighttime ReliefAcetaminophen, Doxylamine succinate, and Dextromethorphan HBr
    68016-709COLD and FLU Nighttime ReliefAcetaminophen, Doxylamine succinate, and Dextromethorphan HBr
    68016-710COLD and FLU Nighttime ReliefAcetaminophen, Doxylamine succinate, and Dextromethorphan HBr
    71141-138Cold and Flu Nighttime ReliefCold and Flu Nighttime Relief
    55315-342Cold and Flu Nighttime ReliefCold and Flu Nighttime Relief
    55315-344Cold and Flu Nighttime ReliefCold and Flu Nighttime Relief
    58602-136AuroQuil COLD and FLU Nighttime ReliefAcetaminophen, Doxylamine succinate, and Dextromethorphan HBr
    58602-137AuroQuil Cold and Flu Nighttime ReliefAcetaminophen, Doxylamine succinate, and Dextromethorphan HBr
    68998-531Night Time Cold and Flu OriginalAcetaminophen, Doxylamine succinate, and Dextromethorphan HBr

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.