NDC 69842-505

Severe Cold Daytime

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Severe Cold Daytime is a Oral Capsule in the Human Otc Drug category. It is labeled and distributed by Cvs Pharmacy. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID69842-505_b7e6c6c4-21e6-467e-9a77-ddb8e15b0f24
NDC69842-505
Product TypeHuman Otc Drug
Proprietary NameSevere Cold Daytime
Generic NameAcetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-12-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCVS Pharmacy
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
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 69842-505-16

16 BLISTER PACK in 1 CARTON (69842-505-16) > 1 CAPSULE in 1 BLISTER PACK
Marketing Start Date2019-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69842-505-16 [69842050516]

Severe Cold Daytime CAPSULE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-12-27

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:258d27a9-fea6-4076-8dfa-77c7e982d250
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1656815
  • UPC Code
  • 0050428381885
  • NDC Crossover Matching brand name "Severe Cold Daytime" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    69842-837Severe Cold DaytimeSevere Cold Daytime
    69842-516Severe Cold DaytimeSevere Cold Daytime
    69842-505Severe Cold DaytimeSevere Cold Daytime
    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
    0363-0719Mucus 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
    0363-0603Severe Cold and Fluacetaminophen, 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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