NDC 53441-311

Day Time Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Day Time Cold and Flu is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by National Distribution Network (smart Choice). The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID53441-311_7b24af92-7228-4fd2-a192-d69244edadbd
NDC53441-311
Product TypeHuman Otc Drug
Proprietary NameDay Time Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-06-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameNational Distribution Network (Smart Choice)
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/15mL; mg/15mL; mg/15mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53441-311-06

177 mL in 1 BOTTLE (53441-311-06)
Marketing Start Date2014-06-30
Marketing End Date2021-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53441-311-06 [53441031106]

Day Time Cold and Flu LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-06-30
Marketing End Date2021-12-30

NDC 53441-311-08 [53441031108]

Day Time Cold and Flu LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-06-30
Marketing End Date2021-12-30

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/15mL

OpenFDA Data

SPL SET ID:806e4b3d-e9e6-4ee0-86f8-b484bd1548d8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113705
    • UPC Code
  • 0752901103075

    • NDC Crossover Matching brand name "Day Time Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    15127-466Day Time Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    46122-184Day time cold and fluDay time cold and flu
    49348-142Day Time Cold and FluDay Time Cold and Flu
    53441-311Day Time Cold and FluDay Time Cold and Flu
    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
    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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.