FDA.reportPublic FDA data

Lotrimin Ultra

Product NDC
11523-4339
11-digit product format
115234339
Labeler code
11523
Product ID
11523-4339_45370735-3f9d-a7f8-e063-6294a90aa0c6
Type
HUMAN OTC DRUG
Nonproprietary name
Butenafine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Bayer Healthcare LLC.
Application
NDA021307
Marketing category
NDA
Marketing start
2002-02-22
Substance
BUTENAFINE HYDROCHLORIDE
Active strength
1 g/100g
Pharmacologic classes
Benzylamine Antifungal [EPC], Benzylamines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lotrimin Ultra
Brand name suffix
Jock Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTENAFINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR8XA2029ZI
Rxcui1298448

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4339-1Lotrimin UltraJock Itch1 in 1 CARTONCREAM19
11523-4339-1Lotrimin UltraJock Itch12 g in 1 TUBECREAM129
11523-4339-2Lotrimin UltraJock Itch15 g in 1 TUBECREAM159
11523-4339-2Lotrimin UltraJock Itch1 in 1 CARTONCREAM19
11523-4339-3Lotrimin UltraJock Itch1 in 1 CARTONCREAM19
11523-4339-3Lotrimin UltraJock Itch30 g in 1 TUBECREAM309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4339LOTRIMIN ULTRA JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [BAYER HEALTHCARE LLC.]8Current NDC, Legacy NDC, 6 package rows20241208_9dfa08fb-0913-4326-b1eb-1425df6a2c82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298448butenafine HCl 1 % Topical CreamPSN9dfa08fb-0913-4326-b1eb-1425df6a2c829
1298448butenafine hydrochloride 10 MG/ML Topical CreamSCD9dfa08fb-0913-4326-b1eb-1425df6a2c829
1298448butenafine HCl 1 % Topical CreamSY9dfa08fb-0913-4326-b1eb-1425df6a2c829

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4339-1115234339011 TUBE in 1 CARTON (11523-4339-1) / 12 g in 1 TUBE1 tube2002-02-220000-00-00NoNoCurrent
11523-4339-2115234339021 TUBE in 1 CARTON (11523-4339-2) / 15 g in 1 TUBE1 tube2002-02-220000-00-00NoNoCurrent
11523-4339-3115234339031 TUBE in 1 CARTON (11523-4339-3) / 30 g in 1 TUBE1 tube2023-09-26NoNoCurrent