FDA.reportPublic FDA data

Lotrimin Ultra

Product NDC
11523-4338
11-digit product format
115234338
Labeler code
11523
Product ID
11523-4338_45370c88-0d4f-d4df-e063-6394a90a6eb7
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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021307-001LOTRIMIN ULTRABUTENAFINE HYDROCHLORIDE1%CREAM / TOPICALRLD, RS2001-12-07

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lotrimin Ultra Athletes FootBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.e258c4ac-53ef-4a99-b732-4985f890b9382025-12-05WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Do not use on nails or scalp in or near the mouth or the eyes for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or irritation gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Lotrimin Ultra
Brand name suffix
Athletes Foot
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
11523-4338-1Lotrimin UltraAthletes Foot12 g in 1 TUBECREAM1211
11523-4338-1Lotrimin UltraAthletes Foot1 in 1 CARTONCREAM111
11523-4338-2Lotrimin UltraAthletes Foot15 g in 1 TUBECREAM1511
11523-4338-2Lotrimin UltraAthletes Foot1 in 1 CARTONCREAM111
11523-4338-4Lotrimin UltraAthletes Foot1 in 1 CARTONCREAM111
11523-4338-4Lotrimin UltraAthletes Foot30 g in 1 TUBECREAM3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4338-1GM - Gram11523-43387b97e907-4d14-497b-8e98-b327a4d2030612017-07-07
11523-4338-4GM - Gram11523-43380fa093bf-8849-46d8-a07e-444260ebd6a012016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Butenafine hydrochlorideACTIVE INGREDIENTR8XA2029ZILOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
ButenafineACTIVE MOIETY91Y494NL0XLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
ceteth-23INACTIVE INGREDIENT495CTZ441VLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9ULOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
propylene glycol dicaprylateINACTIVE INGREDIENT581437HWX2LOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EULOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
trolamineINACTIVE INGREDIENT9O3K93S3TKLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
waterINACTIVE INGREDIENT059QF0KO0RLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4338LOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [BAYER HEALTHCARE LLC.]10Current NDC, Legacy NDC, 6 package rows20241208_e258c4ac-53ef-4a99-b732-4985f890b938.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298448butenafine HCl 1 % Topical CreamPSNe258c4ac-53ef-4a99-b732-4985f890b93811
1298448butenafine hydrochloride 10 MG/ML Topical CreamSCDe258c4ac-53ef-4a99-b732-4985f890b93811
1298448butenafine HCl 1 % Topical CreamSYe258c4ac-53ef-4a99-b732-4985f890b93811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4338-1115234338011 TUBE in 1 CARTON (11523-4338-1) / 12 g in 1 TUBE1 tube2002-02-220000-00-00NoNoCurrent
11523-4338-2115234338021 TUBE in 1 CARTON (11523-4338-2) / 15 g in 1 TUBE1 tube2002-02-220000-00-00NoNoCurrent
11523-4338-4115234338041 TUBE in 1 CARTON (11523-4338-4) / 30 g in 1 TUBE1 tube2002-02-220000-00-00NoNoCurrent