FDA.reportPublic FDA data

Application 020524

Type
NDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MENTAXBUTENAFINE HYDROCHLORIDECREAM;TOPICAL1%YesYes

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
N020524-001MENTAXBUTENAFINE HYDROCHLORIDE1%CREAM / TOPICALRLD1996-10-18

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-183f01610625f2…
2019-09-15 20:21 UTC2019-09N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020524-001MENTAX1%CREAM / TOPICALRLD1996-10-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020524-001MENTAX1%CREAM / TOPICALRLD, RS1996-10-18cb3db0bc1861…

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butenafine HydrochlorideBUTENAFINE HYDROCHLORIDEYYBA CORPe650d8aa-c809-42ee-a1d9-a6321d5364f52025-12-10WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Lotrimin Ultra Jock ItchBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.9dfa08fb-0913-4326-b1eb-1425df6a2c822025-12-05WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Lotrimin Ultra Athletes FootBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.e258c4ac-53ef-4a99-b732-4985f890b9382025-12-05WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Lotrimin UltraBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.d11dfdf6-9b36-03bc-e053-2995a90a0bc32025-12-04WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Lotrimin Ultra RingwormBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.1b438ca7-fd5f-62cb-e063-6294a90ab3a62025-12-04WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Athletes FootBUTENAFINE HYDROCHLORIDECVS Pharmacy5ef3c059-fc25-42da-89c7-b5dab99917952025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Athletes FootBUTENAFINE HYDROCHLORIDERite Aid Corporation103ff59d-7276-4bd9-8633-c992ff311d0e2025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Athletes FootBUTENAFINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCb4913a89-56fd-4710-b28e-6fb6d50fd3f32025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Athletes FootBUTENAFINE HYDROCHLORIDETarget Corporation59494e7f-fd70-4a60-bb1d-4a5ffee945c12025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Athletes FootBUTENAFINE HYDROCHLORIDETOPCO ASSOCIATES LLC3e976ed8-2af8-4d1e-bda6-e2f672c7ec032025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Athletes FootBUTENAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.4b400be5-acaa-4a5f-b8ef-c0df8ad6175f2025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Athletes FootBUTENAFINE HYDROCHLORIDEWalgreen Company4ce8cba1-d637-42c0-8b8b-79bb117b2cd12025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Athletes Foot UltraBUTENAFINE HYDROCHLORIDEH E B0841f741-6409-4d93-a6a7-901808f77bcd2025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Athletes Foot UltraBUTENAFINE HYDROCHLORIDEWal-Mart Stores Inca77a2694-04e7-4b37-ac6a-34f8969459122025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Butenafine HydrochlorideBUTENAFINE HYDROCHLORIDEMEIJER DISTRIBUTION INC4e88068b-1449-43b4-9c7c-4ad8e877459b2025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Butenafine Hydrochloride 1%BUTENAFINE HYDROCHLORIDECVS Pharmacy83830b24-bc94-4764-a6ca-3193abd9de662025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Butenafine Hydrochloride Athletes FootBUTENAFINE HYDROCHLORIDEKroger Company2af91428-3fb9-4974-a55f-87aad750d05b2025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Butenafine HydrochlorideBUTENAFINE HYDROCHLORIDEAlbertsons098dee89-0f7b-4341-a691-bfe6077ff3532025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Butenafine Hydrochloride Jock ItchBUTENAFINE HYDROCHLORIDEWal-Mart Stores Incbe9a411c-55d7-4db5-a420-30013efbbc242025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE
Jock ItchBUTENAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.14a23a39-b567-4db4-bac0-c008c0ca61712025-07-03WarningsName fallback
generic name: BUTENAFINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6151MENTAXbutenafine hydrochlorideMylan Pharmaceuticals Inc.NDACurrent
0378-6151MENTAXbutenafine hydrochlorideMylan Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57657ORIG2019-02-15
20702SUPPL2001-11-20
34769SUPPL2001-06-06
2663SUPPL2001-06-06