NDC 0363-0623

severe cold and flu

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

severe 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; Phenylephrine Hydrochloride.

Product ID0363-0623_148c3ff4-c28e-4538-b9f4-144dcd97a6f6
NDC0363-0623
Product TypeHuman Otc Drug
Proprietary Namesevere cold and flu
Generic NameAcetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-07-23
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameWalgreen Company
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0363-0623-34

237 mL in 1 BOTTLE (0363-0623-34)
Marketing Start Date2018-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-0623-34 [00363062334]

severe cold and flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-20

NDC 0363-0623-40 [00363062340]

severe cold and flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-23

NDC 0363-0623-50 [00363062350]

severe cold and flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-05-16

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:7dc3941a-e5f8-4caa-bae5-6a0d075295cb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1431245

    • NDC Crossover Matching brand name "severe cold and flu" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    0363-0603Severe Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0363-0623severe cold and fluAcetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
    0363-0763Severe Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-1597Severe Cold and Fluacetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
    0363-1940severe cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-5553SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
    68998-163Severe Cold and FluSevere Cold and Flu
    15127-184Severe Cold and FluSevere Cold and Flu
    37808-619severe cold and flusevere cold and flu
    42507-603Severe Cold and FluSevere Cold and Flu
    49035-945Severe Cold and FluSevere Cold and Flu
    56062-319severe cold and flusevere cold and flu
    62011-0241Severe Cold and FluSevere Cold and Flu
    63868-003Severe Cold and FluSevere Cold and Flu
    69842-972Severe Cold and FluSevere Cold and Flu
    63940-342Severe Cold and FluSevere Cold and Flu
    70000-0525Severe Cold and FluSevere Cold and Flu
    0280-1138Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and NightAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0113-7580basic care daytime nighttime cold and fluAcetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
    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
    0363-6596Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-1009Day Time Night Time Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-1142Day Time Night Time Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-0567daytime nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-1733daytime nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0113-0567Good Sense NightTime DayTime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0113-0019Good Sense Severe NightTimeAcetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
    0113-0763Good Sense Severe NightTime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-1031Multi-Symptom Daytime and Nighttime Cold and Flu Relief PlusAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-0331Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
    0363-1011NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
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