NDC 58602-507

COLD and FLU Day Time Multi-Symptom Relief

Acetaminophen, Phenylephrine Hcl, And Dextromethorphan Hbr

COLD and FLU Day Time Multi-Symptom 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; Phenylephrine Hydrochloride.

Product ID58602-507_4d1efd49-857c-4425-a221-9e62c9cf348a
NDC58602-507
Product TypeHuman Otc Drug
Proprietary NameCOLD and FLU Day Time Multi-Symptom Relief
Generic NameAcetaminophen, Phenylephrine Hcl, And Dextromethorphan Hbr
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-10-08
Marketing End Date2021-09-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAurohealth LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/15mL; mg/15mL; mg/15mL
NDC Exclude FlagN

Packaging

NDC 58602-507-16

354 mL in 1 BOTTLE (58602-507-16)
Marketing Start Date2018-10-08
Marketing End Date2021-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-507-16 [58602050716]

COLD and FLU Day Time Multi-Symptom Relief SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-08

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/15mL

OpenFDA Data

SPL SET ID:c00eb45c-5f82-4375-be55-625fd0bc31a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113705
  • NDC Crossover Matching brand name "COLD and FLU Day Time Multi-Symptom Relief" or generic name "Acetaminophen, Phenylephrine Hcl, And Dextromethorphan Hbr"

    NDCBrand NameGeneric Name
    58602-507COLD and FLU Day Time Multi-Symptom ReliefAcetaminophen, Phenylephrine HCl, and Dextromethorphan HBr
    68016-236Cold and Flu Day Time Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    68016-706COLD and FLU Day Time Multi-Symptom ReliefAcetaminophen, Phenylephrine HCl, and Dextromethorphan HBr
    58602-125AuroQuil COLD and FLU Day Time Multi-Symptom ReliefAcetaminophen, Phenylephrine HCl, and Dextromethorphan HBr

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