NDC 11523-4339

Lotrimin Ultra Jock Itch

Butenafine Hydrochloride

Lotrimin Ultra Jock Itch is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Butenafine Hydrochloride.

Product ID11523-4339_4d85da2f-67c8-37ab-e054-00144ff8d46c
NDC11523-4339
Product TypeHuman Otc Drug
Proprietary NameLotrimin Ultra Jock Itch
Generic NameButenafine Hydrochloride
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2002-02-22
Marketing CategoryNDA / NDA
Application NumberNDA021307
Labeler NameBayer Healthcare LLC.
Substance NameBUTENAFINE HYDROCHLORIDE
Active Ingredient Strength1 g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 11523-4339-1

1 TUBE in 1 CARTON (11523-4339-1) > 12 g in 1 TUBE
Marketing Start Date2002-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11523-4339-1 [11523433901]

Lotrimin Ultra Jock Itch CREAM
Marketing CategoryNDA
Application NumberNDA021307
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2002-02-22

NDC 11523-4339-2 [11523433902]

Lotrimin Ultra Jock Itch CREAM
Marketing CategoryNDA
Application NumberNDA021307
Product TypeHUMAN OTC DRUG
Marketing Start Date2002-02-22

Drug Details

Active Ingredients

IngredientStrength
BUTENAFINE HYDROCHLORIDE1 g/100g

OpenFDA Data

SPL SET ID:9dfa08fb-0913-4326-b1eb-1425df6a2c82
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298450
  • 1298448
  • UPC Code
  • 0011017408215
  • NDC Crossover Matching brand name "Lotrimin Ultra Jock Itch" or generic name "Butenafine Hydrochloride"

    NDCBrand NameGeneric Name
    11523-7155Lotrimin Ultra Jock ItchButenafine Hydrochloride
    0363-2100Athletes FootButenafine Hydrochloride
    11673-016Athletes FootButenafine Hydrochloride
    11822-2100Athletes FootButenafine Hydrochloride
    36800-049Athletes FootButenafine Hydrochloride
    51672-2100Athletes FootButenafine Hydrochloride
    69842-986Athletes FootButenafine Hydrochloride
    37808-013Athletes Foot UltraButenafine Hydrochloride
    49035-225Athletes Foot UltraButenafine Hydrochloride
    30142-210Butenafine HydrochlorideButenafine Hydrochloride
    49035-178Butenafine HydrochlorideButenafine Hydrochloride
    69842-989Butenafine Hydrochloride 1%Butenafine Hydrochloride
    0363-2101Jock ItchButenafine Hydrochloride
    51672-2101Jock ItchButenafine Hydrochloride
    11523-0082Lotrimin UltraButenafine hydrochloride
    11523-4338Lotrimin UltraButenafine hydrochloride
    11523-4339Lotrimin UltraButenafine hydrochloride
    11523-7154Lotrimin UltraButenafine Hydrochloride
    0378-6151MENTAXbutenafine hydrochloride

    Trademark Results [Lotrimin Ultra]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LOTRIMIN ULTRA
    LOTRIMIN ULTRA
    76296245 2670158 Live/Registered
    BAYER HEALTHCARE LLC
    2001-08-06

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