NDC 63824-503

Mucinex Nightshift Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, And Triprolidine Hydrochloride

Mucinex Nightshift Cold and Flu is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Rb Health (us) Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Triprolidine Hydrochloride.

Product ID63824-503_297d1a51-73b8-4d2c-be59-a61537a34dfa
NDC63824-503
Product TypeHuman Otc Drug
Proprietary NameMucinex Nightshift Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, And Triprolidine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-06-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRB Health (US) LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE
Active Ingredient Strength650 mg/20mL; mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63824-503-64

1 BOTTLE in 1 CARTON (63824-503-64) > 118 mL in 1 BOTTLE
Marketing Start Date2019-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63824-503-69 [63824050369]

Mucinex Nightshift Cold and Flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-15

NDC 63824-503-66 [63824050366]

Mucinex Nightshift Cold and Flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-15

NDC 63824-503-64 [63824050364]

Mucinex Nightshift Cold and Flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-06-15

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/20mL

OpenFDA Data

SPL SET ID:a51b6312-598e-4a25-a873-6b59bc87d900
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2173667
  • UPC Code
  • 0363824014708
  • NDC Crossover Matching brand name "Mucinex Nightshift Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, And Triprolidine Hydrochloride"

    NDCBrand NameGeneric Name
    72854-233Mucinex Nightshift Cold and Fluacetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride
    63824-223Delsym Nighttime CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and TRIPROLIDINE HYDROCHLORIDE
    63824-503Mucinex NightshiftAcetaminophen, Dextromethorphan Hydrobromide, and Triprolidine Hydrochloride

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