NDC 68016-299

Cold and Chest Congestion Relief

Acetaminophen, Guaifenesin , Phenylephrine Hydrochloride

Cold and Chest Congestion Relief is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Chain Drug Consortium, Llc. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride.

Product ID68016-299_f85dabea-bee0-43b8-ac3d-17f704b63ce0
NDC68016-299
Product TypeHuman Otc Drug
Proprietary NameCold and Chest Congestion Relief
Generic NameAcetaminophen, Guaifenesin , Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-07-18
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameChain Drug Consortium, LLC
Substance NameACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/15mL; mg/15mL; mg/15mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68016-299-08

245 mL in 1 BOTTLE (68016-299-08)
Marketing Start Date2014-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68016-299-08 [68016029908]

Cold and Chest Congestion Relief LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-07-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/15mL

OpenFDA Data

SPL SET ID:15361568-74a9-4dc2-a27a-4e1298c86b51
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 827757
  • UPC Code
  • 0840986025747
  • NDC Crossover Matching brand name "Cold and Chest Congestion Relief" or generic name "Acetaminophen, Guaifenesin , Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    53943-521Cold and Chest Congestion ReliefACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE
    68016-299Cold and Chest Congestion ReliefACETAMINOPHEN, GUAIFENESIN , PHENYLEPHRINE HYDROCHLORIDE

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