NDC 63824-221

Delsym Cough Plus Sore Throat

Acetaminophen And Dextromethorphan Hydrobromide

Delsym Cough Plus Sore Throat is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Rb Health (us) Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide.

Product ID63824-221_2d72f8c7-3d3e-4759-bf15-559dc84caeab
NDC63824-221
Product TypeHuman Otc Drug
Proprietary NameDelsym Cough Plus Sore Throat
Generic NameAcetaminophen And Dextromethorphan Hydrobromide
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRB Health (US) LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength650 mg/20mL; mg/20mL
Pharm ClassesSigma-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 63824-221-66

180 mL in 1 BOTTLE (63824-221-66)
Marketing Start Date2019-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63824-221-66 [63824022166]

Delsym Cough Plus Sore Throat SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-07-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/20mL

OpenFDA Data

SPL SET ID:b37b786e-0cce-419d-94ed-3b64a1eb1201
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1919076
  • UPC Code
  • 0363824819914
  • NDC Crossover Matching brand name "Delsym Cough Plus Sore Throat" or generic name "Acetaminophen And Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    63824-222Childrens DelsymAcetaminophen and Dextromethorphan Hydrobromide
    44237-043Childrens Novex Cold Plus Cough Plus Sore ThroatACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE
    50580-194Childrens TYLENOLAcetaminophen and Dextromethorphan Hydrobromide
    63824-221DelsymAcetaminophen and Dextromethorphan Hydrobromide
    69423-972Vicks DayQuil HIGH BLOOD PRESSUREAcetaminophen and Dextromethorphan Hydrobromide

    Trademark Results [Delsym]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DELSYM
    DELSYM
    97203302 not registered Live/Pending
    RB Health (US) LLC
    2022-01-05
    DELSYM
    DELSYM
    78545210 not registered Dead/Abandoned
    MAJEDO CORPORATION
    2005-01-11
    DELSYM
    DELSYM
    73404418 1267664 Live/Registered
    Pennwalt Corporation
    1982-12-01

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