NDC 21695-517

Delsym

Dextromethorphan Polistirex

Delsym is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Dextromethorphan.

Product ID21695-517_4abb0813-e080-4bae-b829-e2c29d0a8d4f
NDC21695-517
Product TypeHuman Otc Drug
Proprietary NameDelsym
Generic NameDextromethorphan Polistirex
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2009-09-04
Marketing CategoryNDA / NDA
Application NumberNDA018658
Labeler NameRebel Distributors Corp
Substance NameDEXTROMETHORPHAN
Active Ingredient Strength30 mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-517-30

90 mL in 1 BOTTLE (21695-517-30)
Marketing Start Date2009-09-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-517-30 [21695051730]

Delsym SYRUP
Marketing CategoryNDA
Application NumberNDA018658
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-09-04
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN30 mg/5mL

OpenFDA Data

SPL SET ID:4abb0813-e080-4bae-b829-e2c29d0a8d4f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1373045
  • 1373128
  • NDC Crossover Matching brand name "Delsym" or generic name "Dextromethorphan Polistirex"

    NDCBrand NameGeneric Name
    70518-1912DelsymDelsym
    17856-0172DelsymDelsym
    21695-517DelsymDelsym
    21695-518DelsymDelsym
    50090-0224DelsymDelsym
    63824-172DelsymDelsym
    63824-171DelsymDelsym
    63824-176DelsymDelsym
    63824-175DelsymDelsym
    0113-7384basic care cough DMdextromethorphan polistirex
    0363-0899childrens cough dmDextromethorphan polistirex
    0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0363-0384Cough DMdextromethorphan polistirex
    0363-0494Cough DMdextromethorphan polistirex
    0363-0958Cough DMdextromethorphan polistirex
    0904-6312cough dmdextromethorphan polistirex
    11822-0384Cough DMdextromethorphan polistirex
    11822-0494Cough DMdextromethorphan polistirex
    0113-0384good sense cough dmdextromethorphan polistirex
    0113-0958Good Sense Cough DMdextromethorphan polistirex
    0031-8655Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8753Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8754Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8755Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    11673-114up and up 12 hour cough reliefdextromethorphan polistirex

    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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