NDC 0363-1209

Cold Flu and Sore Throat

Acetaminophen, Dextromethporphan Hbr, Guaifenesin, Phenylephrine Hcl

Cold Flu and Sore Throat is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Walgreen Company. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID0363-1209_33041744-c850-4dc1-b8dd-ea6b9e5dc1e3
NDC0363-1209
Product TypeHuman Otc Drug
Proprietary NameCold Flu and Sore Throat
Generic NameAcetaminophen, Dextromethporphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-08-04
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameWalgreen Company
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/20mL; mg/20mL; mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0363-1209-30

1 BOTTLE in 1 CARTON (0363-1209-30) > 180 mL in 1 BOTTLE
Marketing Start Date2018-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-1209-30 [00363120930]

Cold Flu and Sore Throat SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-08-04

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/20mL

OpenFDA Data

SPL SET ID:33041744-c850-4dc1-b8dd-ea6b9e5dc1e3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1116572
  • NDC Crossover Matching brand name "Cold Flu and Sore Throat" or generic name "Acetaminophen, Dextromethporphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    0363-1209Cold Flu and Sore ThroatAcetaminophen, Dextromethporphan HBr, Guaifenesin, Phenylephrine HCl
    41250-381cold flu and sore throatAcetaminophen, dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    55910-619Cold Flu and Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    55910-838Cold Flu and Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    56062-197Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    59779-689Cold Flu and Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    69842-205cold flu and sore throatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    72476-197COLD FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    0113-7303basic care mucus relief cold flu and sore throatAcetaminophen, Dextromethporphan HBr, Guaifenesin, Phenylephrine HCl

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