NDC 65193-125

Red Label Ephedrine Plus

Ephedrine Hydrochloride, Guaifenesin

Red Label Ephedrine Plus is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Dickey Consumer Products Dba Dmd. The primary component is Ephedrine Hydrochloride; Guaifenesin.

Product ID65193-125_d63abbf4-7716-4a78-86d3-d9539aa7a4d9
NDC65193-125
Product TypeHuman Otc Drug
Proprietary NameRed Label Ephedrine Plus
Generic NameEphedrine Hydrochloride, Guaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-04-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDickey Consumer Products DBA DMD
Substance NameEPHEDRINE HYDROCHLORIDE; GUAIFENESIN
Active Ingredient Strength13 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65193-125-48

48 TABLET in 1 BLISTER PACK (65193-125-48)
Marketing Start Date2019-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65193-125-48 [65193012548]

Red Label Ephedrine Plus TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-04-02

Drug Details

Active Ingredients

IngredientStrength
EPHEDRINE HYDROCHLORIDE12.5 mg/1

OpenFDA Data

SPL SET ID:bc11389f-c988-4f67-a56e-6eaad5cb1883
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1115991
    • UPC Code
  • 0098443170442

    • NDC Crossover Matching brand name "Red Label Ephedrine Plus" or generic name "Ephedrine Hydrochloride, Guaifenesin"

    NDCBrand NameGeneric Name
    65193-125Red Label Ephedrine Plusephedrine hydrochloride, guaifenesin
    65193-320Ephed Asthmaephedrine hydrochloride, guaifenesin
    65193-225Ephed Plusephedrine hydrochloride, guaifenesin
    65193-340Red Label Ephed Plusephedrine hydrochloride, guaifenesin
    70258-320VASOPRO EPHEDRINEEPHEDRINE HYDROCHLORIDE, GUAIFENESIN
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.