NDC 55301-316

Severe cold and cough relief

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Severe cold and cough relief is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Aafes/your Military Exchanges. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID55301-316_488c1a12-080c-4671-aa03-1ee9da9ab9ba
NDC55301-316
Product TypeHuman Otc Drug
Proprietary NameSevere cold and cough relief
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2015-12-16
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAAFES/Your Military Exchanges
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55301-316-08

245 mL in 1 BOTTLE, PLASTIC (55301-316-08)
Marketing Start Date2015-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55301-316-08 [55301031608]

Severe cold and cough relief LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-12-16
Marketing End Date2020-12-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:7f029f38-4a06-4aa8-82cb-c64da4bedac8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113705
  • UPC Code
  • 0614299404373
  • NDC Crossover Matching brand name "Severe cold and cough relief" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    55301-316Severe cold and cough reliefSevere cold and cough relief
    0280-1590Alka-Seltzer Plus Maximum Strength Day Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0280-1630Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gelsacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
    0280-1221Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels DayAcetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    0113-7656basic care daytime cold and fluacetaminophen, dextromethorphan hydrobromide, Phenylephrine hydrochloride
    21130-598Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    21130-650Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    21130-868Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    11868-311Cold PreparationAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    11868-466Cold PreparationAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    21130-468Day timeAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    15127-466Day Time Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0904-5763Day Time Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    21130-866Day Time Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0363-1140Daytime Cold and Fluacetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    11822-1583Daytime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0363-1000Daytime Cold and Flu Reliefacetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0363-1003Daytime Cold and Flu Reliefacetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    21130-311Daytime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    21130-471Daytime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0113-0096good sense flu and severe cold and coughAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    11822-0096severe cold cough and flu reliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    21130-937signature care daytime severe coldacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

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