NDC 0363-2301

Cold and Flu

Acetaminophen, Dextromethporphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

Cold and Flu 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 ID0363-2301_9ccf026d-3237-4b46-ae07-c4dce5562746
NDC0363-2301
Product TypeHuman Otc Drug
Proprietary NameCold and Flu
Generic NameAcetaminophen, Dextromethporphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-07-12
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
Pharm ClassesAdrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0363-2301-30

180 mL in 1 BOTTLE (0363-2301-30)
Marketing Start Date2019-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-2301-30 [00363230130]

Cold and Flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-12

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/20mL

NDC Crossover Matching brand name "Cold and Flu" or generic name "Acetaminophen, Dextromethporphan Hydrobromide, Guaifenesin, 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
0363-6596Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, 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
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