NDC 36800-893

Topcare childrens cold cough and sore throat

Acetaminophen, Dextromethorphan Hydrobromide

Topcare childrens cold cough and sore throat is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide.

Product ID36800-893_2efad63b-4a3d-4c2a-a8bd-a08fdf476696
NDC36800-893
Product TypeHuman Otc Drug
Proprietary NameTopcare childrens cold cough and sore throat
Generic NameAcetaminophen, Dextromethorphan Hydrobromide
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2019-08-13
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTopco Associates LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength160 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 36800-893-26

1 BOTTLE in 1 CARTON (36800-893-26) > 118 mL in 1 BOTTLE
Marketing Start Date2019-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-893-26 [36800089326]

Topcare childrens cold cough and sore throat SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-13

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN160 mg/5mL

OpenFDA Data

SPL SET ID:467a8f31-c0bc-4a87-a0f0-dcc50c9a7c2f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1370113
  • NDC Crossover Matching brand name "Topcare childrens cold cough and sore throat" or generic name "Acetaminophen, Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    36800-893Topcare childrens cold cough and sore throatacetaminophen, dextromethorphan Hydrobromide
    0113-7101Basic Care childrens cold and cough and sore throatacetaminophen, dextromethorphan hydrobromide
    69842-622childrens cough and sore throatacetaminophen, dextromethorphan Hydrobromide
    11822-2023childrens pain relief cold and cough and sore throatacetaminophen, dextromethorphan hydrobromide
    11523-0093Coricidin HBP Maximum Strength Cold, Cough and Fluacetaminophen, dextromethorphan hydrobromide
    0363-0029Cough and Sore ThroatAcetaminophen, Dextromethorphan hydrobromide
    0031-8750Robitussin Maximum Strength Severe Cough Plus Sore Throatacetaminophen, dextromethorphan hydrobromide
    37000-027Vicks DayQuilAcetaminophen, Dextromethorphan Hydrobromide

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.