NDC 37012-459

cold and flu relief

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate

cold and flu relief is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Shopko Stores Operating Co., Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID37012-459_75fa82fb-02f1-428d-86aa-7fc1c1b30b93
NDC37012-459
Product TypeHuman Otc Drug
Proprietary Namecold and flu relief
Generic NameAcetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2013-08-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameShopko Stores Operating Co., 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 37012-459-40

354 mL in 1 BOTTLE (37012-459-40)
Marketing Start Date2013-08-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 37012-459-40 [37012045940]

cold and flu relief SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-05

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:6c050441-3b62-40c7-9cf0-50b9c3efa081
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043400

    • NDC Crossover Matching brand name "cold and flu relief" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate"

    NDCBrand NameGeneric Name
    0363-4661Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    0363-9974Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    0904-6793Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    0904-6995Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    71144-0001Cold and Flu ReliefCold and Flu Relief
    71409-304COLD and FLU RELIEFCOLD and FLU RELIEF
    37012-459cold and flu reliefcold and flu relief
    50441-0005Cold and Flu ReliefCold and Flu Relief
    50844-012Cold and Flu ReliefCold and Flu Relief
    61096-1002Cold and Flu ReliefCold and Flu Relief
    61727-303Cold and Flu ReliefCold and Flu Relief
    65808-024Cold and Flu ReliefCold and Flu Relief
    11822-0591cold and flu reliefcold and flu relief
    76524-501COLD AND FLU RELIEFCOLD AND FLU RELIEF
    10202-0567 select night time reliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    10202-3357 select night time reliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0904-6465all niteAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-7459Basic Care NighttimeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-7056Basic Care Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-0401Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-0566Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-0917Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-6600Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    0363-7311Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    0363-9913Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-0056good sense night timeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-0335good sense night timeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-0459good sense nighttimeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-9975Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    0363-9976Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    11788-017Nighttime Cold and Flu ReliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    11822-0335nighttime cold and flu reliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    11822-0459nighttime cold and flu reliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    11673-019up and up nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    11673-500up and up nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    11673-626up and up nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.