FDA.reportPublic FDA data

Lotrimin Ultra

Product NDC
11523-0082
11-digit product format
115230082
Labeler code
11523
Product ID
11523-0082_4526ca36-993f-b574-e063-6294a90a8fba
Type
HUMAN OTC DRUG
Nonproprietary name
Butenafine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Bayer Healthcare LLC.
Application
NDA021307
Marketing category
NDA
Marketing start
2021-12-20
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

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
application applno (NDA): 021307
application number: NDA021307
Lotrimin Ultra Athletes FootBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.e258c4ac-53ef-4a99-b732-4985f890b9382025-12-05WarningsExact identifier
application applno (NDA): 021307
application number: NDA021307
Lotrimin UltraBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.d11dfdf6-9b36-03bc-e053-2995a90a0bc32025-12-04WarningsExact identifier
application applno (NDA): 021307
application number: NDA021307
ndc (product): 11523-0082
Lotrimin Ultra RingwormBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.1b438ca7-fd5f-62cb-e063-6294a90ab3a62025-12-04WarningsExact identifier
application applno (NDA): 021307
application number: NDA021307

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTENAFINE HYDROCHLORIDE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R8XA2029ZIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1298448Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d11dfdf6-9b36-03bc-e053-2995a90a0bc3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0082-1Lotrimin Ultra20 g in 1 TUBE, WITH APPLICATORCREAM207
11523-0082-1Lotrimin Ultra1 in 1 CARTONCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0082LOTRIMIN ULTRA (BUTENAFINE HYDROCHLORIDE) CREAM [BAYER HEALTHCARE LLC.]6Current NDC, Legacy NDC, 2 package rows20241208_d11dfdf6-9b36-03bc-e053-2995a90a0bc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298448butenafine HCl 1 % Topical CreamPSNd11dfdf6-9b36-03bc-e053-2995a90a0bc37
1298448butenafine hydrochloride 10 MG/ML Topical CreamSCDd11dfdf6-9b36-03bc-e053-2995a90a0bc37
1298448butenafine HCl 1 % Topical CreamSYd11dfdf6-9b36-03bc-e053-2995a90a0bc37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11523-0082-1115230082011 TUBE, WITH APPLICATOR in 1 CARTON (11523-0082-1) / 20 g in 1 TUBE, WITH APPLICATOR2021-12-200000-00-00NoNoCurrent