NDC 0485-0204

Rynex DM

Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Rynex DM is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc. The primary component is Brompheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID0485-0204_26c24b35-d227-4552-827c-a2ebf71658a3
NDC0485-0204
Product TypeHuman Otc Drug
Proprietary NameRynex DM
Generic NameBrompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2011-03-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameEdwards Pharmaceuticals, Inc
Substance NameBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength1 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0485-0204-04

118 mL in 1 BOTTLE, PLASTIC (0485-0204-04)
Marketing Start Date2011-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0485-0204-04 [00485020404]

Rynex DM LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-03-14
Inactivation Date2020-01-31
Reactivation Date2020-04-08

NDC 0485-0204-16 [00485020416]

Rynex DM LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-03-14
Inactivation Date2020-01-31
Reactivation Date2020-04-08

NDC 0485-0204-10 [00485020410]

Rynex DM LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-06-27
Marketing End Date2016-10-18

Drug Details

Active Ingredients

IngredientStrength
BROMPHENIRAMINE MALEATE1 mg/5mL

OpenFDA Data

SPL SET ID:7be2c282-24ba-4f19-9b14-872d3f5746a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1090463
  • NDC Crossover Matching brand name "Rynex DM" or generic name "Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    53163-101Altipres-BBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    45737-226Bio T Pres-BBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    0485-0204RynexBrompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

    Trademark Results [Rynex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RYNEX
    RYNEX
    85264524 4038485 Dead/Cancelled
    Rynex Holdings Ltd.
    2011-03-11
    RYNEX
    RYNEX
    78868216 not registered Dead/Abandoned
    Han S. Choi
    2006-04-24
    RYNEX
    RYNEX
    75867168 not registered Dead/Abandoned
    Rynex Holdings Ltd.
    1999-12-08
    RYNEX
    RYNEX
    74688549 not registered Dead/Abandoned
    Rynex Holdings Ltd.
    1995-06-14

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.