NDC 70692-108

Acetaminophen 500mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg

Acetaminophen 500mg, Dextromethorphan Hbr 10mg, Guaifenesin 200mg, Phenylephrine Hcl 5mg

Acetaminophen 500mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Strive Pharmaceuticals Inc. The primary component is Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide; Acetaminophen; Guaifenesin.

Product ID70692-108_9239bf18-0e2a-20d5-e053-2a95a90addc8
NDC70692-108
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen 500mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg
Generic NameAcetaminophen 500mg, Dextromethorphan Hbr 10mg, Guaifenesin 200mg, Phenylephrine Hcl 5mg
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-12-20
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameStrive Pharmaceuticals Inc
Substance NamePHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN
Active Ingredient Strength5 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70692-108-41

4 TABLET in 1 PACKAGE (70692-108-41)
Marketing Start Date2018-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70692-108-41 [70692010841]

Acetaminophen 500mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-20

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:9239bf18-0e2b-20d5-e053-2a95a90addc8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1110988

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