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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11523-7154DDiscontinued by firm2026-08-17
excluded packagepackage11523-715411523-7154-1DDiscontinued by firm2026-08-17
excluded packagepackage11523-715411523-7154-2DDiscontinued by firm2026-08-17
excluded packagepackage11523-715411523-7154-3DDiscontinued by firm2026-08-17
excluded packagepackage11523-715411523-7154-4DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-7154-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-7154-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-7154-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-7154-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-7154-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-7154-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-7154-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-7154-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11523-7154-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11523-7154-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11523-7154-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11523-7154-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11523-7154-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11523-7154-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11523-7154-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11523-7154-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11523-7154-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11523-7154-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11523-7154-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11523-7154-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11523-7154-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11523-7154-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11523-7154-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11523-7154-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11523-7154-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11523-7154-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11523-7154-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11523-7154-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11523-7154-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11523-7154-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11523-7154-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11523-7154-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11523-7154-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11523-7154-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11523-7154-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11523-7154-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11523-7154-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11523-7154-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11523-7154-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11523-7154-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11523-7154-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11523-7154-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11523-7154-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11523-7154-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11523-7154-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11523-7154-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11523-7154-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11523-7154-4557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-073f01610625f2…
2019-09-15 20:21 UTC2019-09N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07e64feba35796…

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
Lotrimin Ultra RingwormBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.1b438ca7-fd5f-62cb-e063-6294a90ab3a62025-12-04WarningsExact identifier
application applno (NDA): 021307
application number: NDA021307