NDC 36800-291

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 ID36800-291_24f413f7-773e-480f-8f94-1a1597d0788b
NDC36800-291
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 Date2015-08-04
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
Pharm ClassesAdrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 36800-291-40

355 mL in 1 BOTTLE (36800-291-40)
Marketing Start Date2015-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-291-40 [36800029140]

topcare nite time cold and flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-04

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:28ef87e8-29e5-444d-b1f7-5c38a7f758d3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1431245

    • 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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