NDC 36800-335

topcare nite time cold and flu relief

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate

topcare nite time cold and flu relief is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID36800-335_1657c3bf-85e0-40f8-a770-d5c7a107d198
NDC36800-335
Product TypeHuman Otc Drug
Proprietary Nametopcare nite time cold and flu relief
Generic NameAcetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2011-08-18
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTopco Associates LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 36800-335-34

237 mL in 1 BOTTLE (36800-335-34)
Marketing Start Date2012-07-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-335-40 [36800033540]

topcare nite time cold and flu relief SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-07-16

NDC 36800-335-38 [36800033538]

topcare nite time cold and flu relief SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-18
Marketing End Date2013-09-27

NDC 36800-335-30 [36800033530]

topcare nite time cold and flu relief SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-22
Marketing End Date2013-11-27

NDC 36800-335-34 [36800033534]

topcare nite time cold and flu relief SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-07-17

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:31210a95-f9dc-49db-aab5-25c4dca49266
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043400
  • NDC Crossover Matching brand name "topcare nite time cold and flu relief" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate"

    NDCBrand NameGeneric Name
    36800-459topcare nite time cold and flu relieftopcare nite time cold and flu relief
    36800-335topcare nite time cold and flu relieftopcare nite time cold and flu relief
    36800-872Topcare Nite Time Cold and flu reliefTopcare Nite Time Cold 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
    15127-343Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    15127-344Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    15127-660Cold 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
    11822-3335Night Time Cold and Flu ReliefAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    11822-3392Night Time Cold and Flu ReliefAcetaminophen, 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
    21130-899Nighttime 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.