NDC 53345-004

DayTime Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

DayTime Cold and Flu is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID53345-004_0b0e4538-4263-4241-b420-c5b60b2c54c0
NDC53345-004
Product TypeHuman Otc Drug
Proprietary NameDayTime Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2013-06-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53345-004-01

1 BAG in 1 BOX (53345-004-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Start Date2013-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53345-004-01 [53345000401]

DayTime Cold and Flu CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-06-15

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:5b55d1df-275b-40d8-bde3-fc43313b7eb3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1086997

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

    NDCBrand NameGeneric Name
    0363-0109DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBr,GUAIFENESIN, PHENYLEPHRINE HCl
    0363-0853Daytime Cold and FluAcetaminophine Dextromethorphan HBr Phenylphrine HCl
    0363-1140Daytime Cold and Fluacetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    11822-1583Daytime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    11822-3391Daytime Cold and FluAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    68016-727Daytime Cold and FluDaytime Cold and Flu
    70005-003DAYTIME COLD AND FLUDAYTIME COLD AND FLU
    70677-0011DayTime Cold and FluDayTime Cold and Flu
    76168-055DayTime Cold and FluDayTime Cold and Flu
    30142-704daytime cold and fludaytime cold and flu
    37012-656Daytime Cold and FluDaytime Cold and Flu
    37835-695DAYTIME COLD AND FLUDAYTIME COLD AND FLU
    41250-603Daytime Cold and FluDaytime Cold and Flu
    41250-548daytime cold and fludaytime cold and flu
    49580-0467Daytime Cold and FluDaytime Cold and Flu
    49580-0466Daytime Cold and FluDaytime Cold and Flu
    51013-134DayTime Cold and FluDayTime Cold and Flu
    51013-183Daytime Cold and FluDaytime Cold and Flu
    51013-130DAYTIME COLD and FLUDAYTIME COLD and FLU
    53345-025DayTime Cold and FluDayTime Cold and Flu
    53345-004DayTime Cold and FluDayTime Cold and Flu
    55301-066Daytime Cold and FluDaytime Cold and Flu
    62011-0318DayTime Cold and FluDayTime Cold and Flu
    63941-466Daytime Cold and FluDaytime Cold and Flu
    63868-864DayTime Cold and FluDayTime Cold and Flu
    41250-646DayTime Cold and FluDayTime Cold and Flu
    59428-848Daytime Cold and FluDaytime Cold and Flu
    41250-569daytime cold and fludaytime cold and flu
    66715-6815Daytime Cold and FluDaytime Cold and Flu
    66715-6715Daytime Cold and FluDaytime Cold and Flu
    72476-898Daytime Cold and FluDaytime Cold and Flu
    69168-417Daytime Cold and FluDaytime Cold and Flu
    30142-666Daytime Cold and FluDaytime 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
    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
    0363-1000Daytime 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
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