NDC 58809-999

VANACOF

Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride

VANACOF is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Chlophedianol Hydrochloride; Dexchlorpheniramine Maleate; Pseudoephedrine Hydrochloride.

Product ID58809-999_6e48017a-a48a-4b1a-8e4b-5d4003560de5
NDC58809-999
Product TypeHuman Otc Drug
Proprietary NameVANACOF
Generic NameChlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2008-04-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, INC
Substance NameCHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 58809-999-01

473 mL in 1 BOTTLE (58809-999-01)
Marketing Start Date2008-04-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-999-02 [58809099902]

VANACOF LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-04-22

NDC 58809-999-01 [58809099901]

VANACOF LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2008-04-22

Drug Details

Active Ingredients

IngredientStrength
CHLOPHEDIANOL HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:cf3886ab-62b3-497a-a587-18cbfbaf3634
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1369424

    • Medicade Reported Pricing

    58809099901 VANACOF LIQUID

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "VANACOF" or generic name "Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    58809-999VANACOFChlophedianol Hydrochloride, Dexchlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
    69367-183chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloridechlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride

    Trademark Results [VANACOF]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VANACOF
    VANACOF
    77310107 3565619 Live/Registered
    GM Pharmaceuticals, Inc.
    2007-10-22
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.