NDC 11584-1047

DESPEC

Dextromethorphan Hydrobromide, Guaifenesin, Phenyllephrine Hydrochloride

DESPEC is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by International Ethical Labs. The primary component is Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride; Guaifenesin.

Product ID11584-1047_78727a73-e7aa-bef6-e053-2a91aa0aa4a3
NDC11584-1047
Product TypeHuman Otc Drug
Proprietary NameDESPEC
Generic NameDextromethorphan Hydrobromide, Guaifenesin, Phenyllephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2016-01-11
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameINTERNATIONAL ETHICAL LABS
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
Active Ingredient Strength10 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 11584-1047-6

1 mL in 1 BOTTLE (11584-1047-6)
Marketing Start Date2016-01-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11584-1047-6 [11584104706]

DESPEC LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-01-11
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

OpenFDA Data

SPL SET ID:65d116e7-8963-0b01-e053-2a91aa0abac0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1044949
  • NDC Crossover Matching brand name "DESPEC" or generic name "Dextromethorphan Hydrobromide, Guaifenesin, Phenyllephrine Hydrochloride"

    NDCBrand NameGeneric Name
    11584-1046DESPECDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    11584-1047DESPECDextromethorphan Hydrobromide, Guaifenesin, Phenyllephrine Hydrochloride
    11584-1110DespecDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

    Trademark Results [DESPEC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DESPEC
    DESPEC
    78105732 2639859 Live/Registered
    International Ethical Labs., Inc.
    2002-01-30
    DESPEC
    DESPEC
    74246164 1734326 Dead/Cancelled
    INTERNATIONAL ETHICAL LABS, INC.
    1992-02-12

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