NDC 36800-809

topcare childrens cold and flu

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

topcare childrens cold and flu is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID36800-809_6e3c7fea-d43e-4a8f-96fa-8e6ccc08d7aa
NDC36800-809
Product TypeHuman Otc Drug
Proprietary Nametopcare childrens cold and flu
Generic NameAcetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2019-09-13
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTopco Associates LLC
Substance NameACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength160 mg/5mL; mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-809-26

1 BOTTLE in 1 CARTON (36800-809-26) > 118 mL in 1 BOTTLE
Marketing Start Date2019-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-809-26 [36800080926]

topcare childrens cold and flu SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-13

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN160 mg/5mL

OpenFDA Data

SPL SET ID:8c20868f-1399-4e55-91b4-44d01b7966ac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113397

    • NDC Crossover Matching brand name "topcare childrens cold and flu" or generic name "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    36800-809topcare childrens cold and fluacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    0280-1212Alka-Seltzer Plus Maximum Strength Cold and CoughAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    0280-0023Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizzacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    0280-1560Alka-Seltzer Plus Severe Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    48201-009Calmadol PlusACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    56062-239childrens cold and fluacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    63868-374Childrens Multi-Symptom Cold PlusAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    0363-0034Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    11822-5047Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    15127-931Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    21130-034Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    41520-704Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    46122-310Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    55315-304Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    55910-043Childrens Plus Multi Symptom ColdAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    51467-007COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    55910-014DG Health cold multi symptomAcetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    58552-137Giltuss Childrens MultiSymptom Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    58552-136Giltuss MultiSymptom Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    48201-001Sanaflu XtraACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    49873-114Stonaacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
    49873-113Stona-Sacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
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