NDC 58602-504

Primary Health - Fast Maximum Cold, Flu and Sore Throat Relief

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin And Phenylephrine Hydrochloride

Primary Health - Fast Maximum Cold, Flu and Sore Throat Relief is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Aurohealth Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID58602-504_0927aea7-2151-4eef-b0cc-6af66ecebfe5
NDC58602-504
Product TypeHuman Otc Drug
Proprietary NamePrimary Health - Fast Maximum Cold, Flu and Sore Throat Relief
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin And Phenylephrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-07-03
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAurohealth LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/20mL; mg/20mL; mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58602-504-18

180 mL in 1 BOTTLE (58602-504-18)
Marketing Start Date2015-07-03
Marketing End Date2022-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-504-18 [58602050418]

Primary Health - Fast Maximum Cold, Flu and Sore Throat Relief SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-03

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/20mL

OpenFDA Data

SPL SET ID:0927aea7-2151-4eef-b0cc-6af66ecebfe5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1116572
  • NDC Crossover Matching brand name "Primary Health - Fast Maximum Cold, Flu and Sore Throat Relief" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    58602-504Primary Health - Fast Maximum Cold, Flu and Sore Throat ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
    58602-157Auro Mucus - Childrens Cold, Cough and Sore ThroatAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
    58602-110AuroMucus - Fast Maximum Cold, Flu and Sore Throat ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
    58602-518Childrens Cold, Cough and Sore ThroatAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
    69842-006CVS - Childrens Mucus Relief Cough, Cold and Sore ThroatAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
    67091-331Fast Acting Cold, Flu and Sore Throat ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
    49738-995KMart - Fast Maximum Cold, Flu and Sore Throat ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
    50066-916TUKOL MAX ACTION COLD SORE THROAT AND COUGHAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
    58933-540Vicks DayQuil Severe Hot RemedyAcetaminophen, Dextromethorphan hydrobromide, Guaifenesin and phenylephrine hydrochloride
    69423-976Vicks DayQuil Severe Hot RemedyAcetaminophen, Dextromethorphan hydrobromide, Guaifenesin and phenylephrine hydrochloride
    0363-8592Walgreens Severe Warming Cold and Flu For Adultsacetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride

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