NDC 56062-198

Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

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

Product ID56062-198_9467f825-2a73-83b3-e053-2995a90a081c
NDC56062-198
Product TypeHuman Otc Drug
Proprietary NameCold and Flu
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2019-09-13
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePUBLIX SUPER MARKETS INC
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 56062-198-02

2 BLISTER PACK in 1 CARTON (56062-198-02) > 10 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2019-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 56062-198-02 [56062019802]

Cold and Flu TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-13

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:01e1ad15-0ef5-4d6a-a9c1-19a5f2b20148
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1110988
  • UPC Code
  • 0041415441736
  • NDC Crossover Matching brand name "Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-0401Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-0566Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-0573Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0640Cold and FluAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0666Cold and Fluacetaminophen, dextromethorphan Hbr, Phenylephrine HCl
    0363-0917Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-1213Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-2211Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-2212Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-2301Cold and Fluacetaminophen, dextromethporphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-3430Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    0363-6177Cold and FluAcetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl
    0363-6406Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl
    0363-6590Cold and FluAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    42507-522Cold and FluCold and Flu
    42507-056Cold and FluCold and Flu
    42507-401Cold and FluCold and Flu
    42507-001cold and flucold and flu
    50845-0107Cold and FluCold and Flu
    56062-198Cold and FluCold and Flu
    55910-862COLD and FLUCOLD and FLU
    68210-1110COLD and FLUCOLD and FLU
    0363-7301Cold and FluCold and Flu
    0280-0921Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE

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