NDC 36800-560

topcare nite time cold and flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

topcare nite time cold and flu is a Oral Tablet, Film Coated 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 ID36800-560_6a028e31-93d2-4a45-9d1c-b1dc11d64eea
NDC36800-560
Product TypeHuman Otc Drug
Proprietary Nametopcare nite time cold and flu
Generic NameAcetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-07-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTopco Associates LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-560-62

12 BLISTER PACK in 1 CARTON (36800-560-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2015-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-560-62 [36800056062]

topcare nite time cold and flu TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-30

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:1f6e33ed-8766-4ee2-8138-30064082b609
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1546881

    • 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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