FDA.reportPublic FDA data

Lotrimin Ultra

Product NDC
11523-7154
11-digit product format
115237154
Labeler code
11523
Product ID
11523-7154_47e50ab6-5028-0fe0-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
Butenafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
NDA021307
Marketing category
NDA
Marketing start
1993-09-23
Marketing end
0000-00-00
Substance
BUTENAFINE HYDROCHLORIDE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11523-7154DDiscontinued by firm2026-07-31
excluded packagepackage11523-715411523-7154-1DDiscontinued by firm2026-07-31
excluded packagepackage11523-715411523-7154-2DDiscontinued by firm2026-07-31
excluded packagepackage11523-715411523-7154-3DDiscontinued by firm2026-07-31
excluded packagepackage11523-715411523-7154-4DDiscontinued by firm2026-07-31

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 Jock ItchBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.9dfa08fb-0913-4326-b1eb-1425df6a2c822025-12-05WarningsExact identifier
Lotrimin Ultra Athletes FootBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.e258c4ac-53ef-4a99-b732-4985f890b9382025-12-05WarningsExact identifier
Lotrimin UltraBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.d11dfdf6-9b36-03bc-e053-2995a90a0bc32025-12-04WarningsExact identifier
Lotrimin Ultra RingwormBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.1b438ca7-fd5f-62cb-e063-6294a90ab3a62025-12-04WarningsExact 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.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7154-3GM - Gram11523-7154bc0b2d8d-4da3-43d7-a781-84d6b366d3ab12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Butenafine HydrochlorideACTIVE INGREDIENTR8XA2029ZILOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2
ButenafineACTIVE MOIETY91Y494NL0XLOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHLOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2
ceteth-23INACTIVE INGREDIENT495CTZ441VLOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNLOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2
diethanolamineINACTIVE INGREDIENTAZE05TDV2VLOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXLOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9ULOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2
propylene glycol dicaprylateINACTIVE INGREDIENT581437HWX2LOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EULOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APLOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RLOTRIMIN ULTRA ANTIFUNGAL (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE, INC.]2