NDC 36800-763

Topcare Nite Time Cold and Flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

Topcare Nite Time Cold and Flu 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; Phenylephrine Hydrochloride.

Product ID36800-763_4b5931c2-f292-43c6-92f2-791e5a2fb161
NDC36800-763
Product TypeHuman Otc Drug
Proprietary NameTopcare Nite Time Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2014-06-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTopco Associates LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 36800-763-40

355 mL in 1 BOTTLE (36800-763-40)
Marketing Start Date2014-06-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-763-34 [36800076334]

Topcare Nite Time Cold and Flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-06-22

NDC 36800-763-40 [36800076340]

Topcare Nite Time Cold and Flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-06-09

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:5daafb37-f80a-4514-be32-a52e4569a1f7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1431245
    • UPC Code
  • 0036800394018

    • NDC Crossover Matching brand name "Topcare Nite Time Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    36800-143topcare nite time cold and flutopcare nite time cold and flu
    36800-614Topcare Nite Time Cold and FluTopcare Nite Time Cold and Flu
    36800-560topcare nite time cold and flutopcare nite time cold and flu
    36800-291topcare nite time cold and flutopcare nite time cold and flu
    36800-908TopCare Nite Time Cold and fluTopCare Nite Time Cold and flu
    36800-763Topcare Nite Time Cold and FluTopcare Nite Time Cold and Flu
    36800-594topcare nite time cold and flutopcare nite time cold and flu
    36800-307topcare nite time cold and flutopcare nite time cold and flu
    0280-1138Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and NightAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0113-7580basic care daytime nighttime cold and fluAcetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
    0363-1213Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-2211Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-2212Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-6596Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-6770Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-1009Day Time Night Time Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-1142Day Time Night Time Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-0567daytime nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-1733daytime nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0113-0567Good Sense NightTime DayTime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0113-0019Good Sense Severe NightTimeAcetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
    0113-0763Good Sense Severe NightTime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-1031Multi-Symptom Daytime and Nighttime Cold and Flu Relief PlusAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-0331Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
    0363-1011NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
    0363-0623severe cold and fluAcetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
    0363-0763Severe Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-1597Severe Cold and Fluacetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
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