NDC 50804-163

Cold and Flu Severe

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Cold and Flu Severe is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Goodsense. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID50804-163_7e445cde-4411-96f8-e053-2991aa0a47cd
NDC50804-163
Product TypeHuman Otc Drug
Proprietary NameCold and Flu Severe
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2013-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGoodSense
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC SPL Data Element Entries

NDC 50804-163-05 [50804016305]

Cold and Flu Severe TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-07-01
Marketing End Date2016-05-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:65b7895b-2e27-4e75-824b-ecf6017c68d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1110988
    • UPC Code
  • 0846036006711

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

    NDCBrand NameGeneric Name
    36800-502COLD AND FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    11822-5031Cold and Flu SevereCold and Flu Severe
    15127-503Cold and Flu SevereCold and Flu Severe
    41250-663Cold and Flu SevereCold and Flu Severe
    49035-053Cold and Flu severeCold and Flu severe
    49348-118Cold and Flu SevereCold and Flu Severe
    50804-163Cold and Flu SevereCold and Flu Severe
    55315-504Cold and Flu SevereCold and Flu Severe
    55910-054Cold and Flu SevereCold and Flu Severe
    0363-0640Cold and Flu SevereCold and Flu Severe
    50804-503Cold and Flu SevereCold and Flu Severe
    53943-163COLD and FLU SEVERECOLD and FLU SEVERE
    53943-186COLD AND FLU SEVERECOLD AND FLU SEVERE
    79395-503Cold and Flu SevereCold and Flu Severe
    68016-512Cold and Flu SevereCold and Flu Severe
    72476-163Cold and Flu SevereCold and Flu Severe
    0280-0921Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-986Cold and Flu Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37000-524DayQuil Severe plus Vicks VapoCoolAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
    37808-178DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-474Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-298Mucus Relief Cold and Flu All In OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-697Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-764Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37808-164Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37808-497Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37808-079Mucus Relief Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-775Pressure Plus Pain PE Plus ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    15127-184Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37000-810Vicks DayQuilAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
    37000-811Vicks DayQuilAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
    0363-8591Walgreens Severe Cold Multi-Symptom For Adultsacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
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