NDC 0363-0401

Cold and Flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate

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; Doxylamine Succinate.

Product ID0363-0401_0fb0f6df-3aab-44ac-8eb0-ccacae24e56b
NDC0363-0401
Product TypeHuman Otc Drug
Proprietary NameCold and Flu
Generic NameAcetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2011-08-08
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameWalgreen Company
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL
Pharm ClassesAntihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0363-0401-34

237 mL in 1 BOTTLE (0363-0401-34)
Marketing Start Date2012-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-0401-40 [00363040140]

cold and flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-08

NDC 0363-0401-34 [00363040134]

cold and flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-08-15

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:e9d0b6f9-e9f3-431c-9f34-4d63108282a1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043400

    • NDC Crossover Matching brand name "Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate"

    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
    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
    0113-7459Basic Care NighttimeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-7056Basic Care Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-0056good sense night timeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-0335good sense night timeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0113-0459good sense nighttimeAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
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