NDC 69729-782

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl

Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Opmx Llc. The primary component is Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride; Acetaminophen; Guaifenesin.

Product ID69729-782_9a164cfc-b624-9a9f-e053-2a95a90a0173
NDC69729-782
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
Generic NameAcetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2019-02-18
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameOPMX LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN
Active Ingredient Strength10 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69729-782-10

10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69729-782-10)
Marketing Start Date2019-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69729-782-10 [69729078210]

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-18

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

OpenFDA Data

SPL SET ID:9a164cfc-b623-9a9f-e053-2a95a90a0173
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1656815
  • NDC Crossover Matching brand name "Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl" or generic name "Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    55629-015Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HClAcetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
    69729-782Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HClAcetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
    68016-224Childrens Cold, Cough and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    69732-003Head and Coldacetaminophen, guaifenesin, dextromethorphan HBr, phenylephrine HCl

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