NDC 55315-504

Cold and Flu Severe

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

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

Product ID55315-504_74f0583e-0009-4729-ad42-3a50ac5e00c6
NDC55315-504
Product TypeHuman Otc Drug
Proprietary NameCold and Flu Severe
Generic NameAcetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-08-04
Marketing End Date2021-04-03
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameFRED'S, INC.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN

Packaging

NDC 55315-504-08

2 BLISTER PACK in 1 CARTON (55315-504-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2005-08-04
Marketing End Date2021-04-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55315-504-08 [55315050408]

Cold and Flu Severe TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-08-04

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:3c0351f3-83a7-45fc-9278-76b1e9029fab
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1110988
    • UPC Code
  • 0084579131228

    • NDC Crossover Matching brand name "Cold and Flu Severe" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    11822-5031Cold and Flu SevereCold and Flu Severe
    15127-503Cold and Flu SevereCold and Flu Severe
    36800-502COLD 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
    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
    0113-7603Basic Care Daytime Cold and Flu Severeacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0113-7303basic care mucus relief cold flu and sore throatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0640Cold and FluAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0299good sense cold and flu severeAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0234good sense cold head congestionAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0381Good Sense Mucus ReliefAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-1913good sense mucus relief cold flu and sore throatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0579good sense severe coldAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0548Good Sense Severe Daytimeacetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
    0113-0603Good Sense Severe Daytime Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0113-9007Good Sense Severe Tussin CF MaxAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
    0363-0616Mucus ReliefAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0538Mucus Relief Cold Flu Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0719Mucus Relief Cold Flu Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0372Mucus Relief PlusAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0410Mucus Relief Severe ColdAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0503Severe ColdAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0603Severe Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0363-0524Sinus ReliefAcetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl
    0067-8145Theraflu ExpressMax Severe Cold and Flu CapletsAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0067-8132Theraflu ExpressMax Severe Cold and Flu SyrupAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0051Wal Tussin CF MaxAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
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