NDC 58605-423

Maxiphen DM

Guaifenesin, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide

Maxiphen DM is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Mcr American Pharmaceuticals, Inc.. The primary component is Guaifenesin; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID58605-423_1a720629-daee-4f54-b8ed-6d0d69c9d1cd
NDC58605-423
Product TypeHuman Otc Drug
Proprietary NameMaxiphen DM
Generic NameGuaifenesin, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-03-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMCR American Pharmaceuticals, Inc.
Substance NameGUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength400 mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58605-423-01

100 TABLET in 1 BOTTLE, PLASTIC (58605-423-01)
Marketing Start Date2008-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58605-423-01 [58605042301]

Maxiphen DM TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2008-03-31
Marketing End Date2013-09-30
Inactivation Date2019-11-13
Reactivation Date2020-05-20

NDC 58605-423-02 [58605042302]

Maxiphen DM TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-03-31
Marketing End Date2013-09-30
Inactivation Date2019-11-13
Reactivation Date2020-05-20

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN400 mg/1

OpenFDA Data

SPL SET ID:82f1f3c2-5aa1-4508-a585-fa109c66a120
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1305214
  • NDC Crossover Matching brand name "Maxiphen DM" or generic name "Guaifenesin, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    58605-423Maxiphen DMGuaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide
    63824-515Mucinex Fast-MaxGuaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide

    Trademark Results [Maxiphen DM]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MAXIPHEN DM
    MAXIPHEN DM
    78330862 2953702 Dead/Cancelled
    AMBI Pharmaceuticals, Inc.
    2003-11-20

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