NDC 50804-163

Cold and Flu Severe

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Cold and Flu Severe is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Goodsense. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID50804-163_7e445cde-4411-96f8-e053-2991aa0a47cd
NDC50804-163
Product TypeHuman Otc Drug
Proprietary NameCold and Flu Severe
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2013-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGoodSense
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC SPL Data Element Entries

NDC 50804-163-05 [50804016305]

Cold and Flu Severe TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-07-01
Marketing End Date2016-05-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:65b7895b-2e27-4e75-824b-ecf6017c68d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1110988
  • UPC Code
  • 0846036006711