NDC 0363-0603

Severe Cold and Flu

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, 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; Guaifenesin; Phenylephrine Hydrochloride.

Product ID0363-0603_5775e31a-1333-4f37-9a95-0b1f4c4281a2
NDC0363-0603
Product TypeHuman Otc Drug
Proprietary NameSevere Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2013-11-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameWalgreen Company
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
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 0363-0603-34

237 mL in 1 BOTTLE (0363-0603-34)
Marketing Start Date2019-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-0603-34 [00363060334]

Severe Cold and Flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-04-04

NDC 0363-0603-40 [00363060340]

Severe Cold and Flu SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2013-11-21

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/15mL

OpenFDA Data

SPL SET ID:54254b61-7861-4eeb-bd3c-54fd5266f4a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1369842
  • NDC Crossover Matching brand name "Severe Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, 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
    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
    0363-0763Severe Cold and FluSevere Cold and Flu
    0363-1597Severe Cold and FluSevere Cold and Flu
    62011-0241Severe Cold and FluSevere Cold and Flu
    63868-003Severe Cold and FluSevere Cold and Flu
    0363-1940severe 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
    0113-7603Basic Care Daytime Cold and Flu Severeacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0113-7303basic care mucus relief cold flu and sore throatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0640Cold and FluAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0299good sense cold and flu severeAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0234good sense cold head congestionAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0381Good Sense Mucus ReliefAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-1913good sense mucus relief cold flu and sore throatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0579good sense severe coldAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0548Good Sense Severe Daytimeacetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
    0113-0603Good Sense Severe Daytime Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0113-9007Good Sense Severe Tussin CF MaxAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
    0363-0616Mucus ReliefAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0538Mucus Relief Cold Flu Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0372Mucus Relief PlusAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0410Mucus Relief Severe ColdAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0503Severe ColdAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0524Sinus ReliefAcetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl
    0067-8145Theraflu ExpressMax Severe Cold and Flu CapletsAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0067-8132Theraflu ExpressMax Severe Cold and Flu SyrupAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0051Wal Tussin CF MaxAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl

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