NDC 55910-054

Cold and Flu Severe

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

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

Product ID55910-054_c3e6ff35-894a-463e-ae3a-f27d7721724b
NDC55910-054
Product TypeHuman Otc Drug
Proprietary NameCold and Flu Severe
Generic NameAcetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-08-04
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDOLGENCORP, LLC
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 55910-054-08

2 BLISTER PACK in 1 CARTON (55910-054-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2005-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55910-054-08 [55910005408]

Cold and Flu Severe TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-08-04

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:650f8967-1529-473c-9ff0-6851ed7dc8fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1110988
  • UPC Code
  • 0050844503083