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

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