NDC 37808-663

Cold Flu Severe

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

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

Product ID37808-663_941d0acd-5e73-0b56-e053-2995a90a836a
NDC37808-663
Product TypeHuman Otc Drug
Proprietary NameCold Flu Severe
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2018-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHEB
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 37808-663-05

2 BLISTER PACK in 1 CARTON (37808-663-05) > 12 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2018-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 37808-663-05 [37808066305]

Cold Flu Severe TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-05-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:ea39a67d-8a99-4f7c-9925-94b07d0b1092
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1110988
  • UPC Code
  • 0041220385881
  • NDC Crossover Matching brand name "Cold Flu Severe" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    63940-363Cold Flu SevereCold Flu Severe
    72036-155Cold Flu SevereCold Flu Severe
    37808-663Cold Flu SevereCold Flu Severe
    46122-418Cold Flu SevereCold Flu Severe
    62011-0442Cold Flu SevereCold Flu Severe
    70677-0100Cold Flu SevereCold Flu Severe
    0280-0921Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-502COLD AND FLU SEVEREACETAMINOPHEN, 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

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