FDA.reportPublic FDA data

Jock Itch

Product NDC
51672-2101
Requested package NDC
51672-2101-8
11-digit product format
516722101
Labeler code
51672
Product ID
51672-2101_a0159f92-c609-486b-a727-bc4d431ed8eb
Type
HUMAN OTC DRUG
Nonproprietary name
Butenafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., inc.
Application
ANDA205181
Marketing category
ANDA
Marketing start
2017-11-17
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51672-210151672-2101-8DDiscontinued by firm2026-10-30

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A205181-001BUTENAFINE HYDROCHLORIDEBUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16c2088c7a36db…
2026-09-14 22:38:342026-08A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1684e616aacf4f…
2026-08-18 06:07:402026-07A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-163f01610625f2…
2019-09-15 20:21 UTC2019-09A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-163a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2101-1Jock Itch1 in 1 CARTONCREAM16
51672-2101-1Jock Itch15 g in 1 TUBECREAM156
51672-2101-2Jock Itch1 in 1 CARTONCREAM16
51672-2101-2Jock Itch30 g in 1 TUBECREAM306
51672-2101-8Jock Itch1 in 1 CARTONCREAM16
51672-2101-8Jock Itch12 g in 1 TUBECREAM126
51672-2101-9Jock Itch1 in 1 CARTONCREAM16
51672-2101-9Jock Itch24 g in 1 TUBECREAM246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2101JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4Legacy NDC, 8 package rows20171121_14a23a39-b567-4db4-bac0-c008c0ca6171.zip

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butenafine HydrochlorideBUTENAFINE HYDROCHLORIDEMEIJER DISTRIBUTION INC4e88068b-1449-43b4-9c7c-4ad8e877459b2026-09-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Butenafine HydrochlorideBUTENAFINE HYDROCHLORIDEYYBA CORPe650d8aa-c809-42ee-a1d9-a6321d5364f52025-12-10WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Athletes FootBUTENAFINE HYDROCHLORIDECVS Pharmacy5ef3c059-fc25-42da-89c7-b5dab99917952025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Athletes FootBUTENAFINE HYDROCHLORIDERite Aid Corporation103ff59d-7276-4bd9-8633-c992ff311d0e2025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Athletes FootBUTENAFINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCb4913a89-56fd-4710-b28e-6fb6d50fd3f32025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Athletes FootBUTENAFINE HYDROCHLORIDETarget Corporation59494e7f-fd70-4a60-bb1d-4a5ffee945c12025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Athletes FootBUTENAFINE HYDROCHLORIDETOPCO ASSOCIATES LLC3e976ed8-2af8-4d1e-bda6-e2f672c7ec032025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Athletes FootBUTENAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.4b400be5-acaa-4a5f-b8ef-c0df8ad6175f2025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Athletes FootBUTENAFINE HYDROCHLORIDEWalgreen Company4ce8cba1-d637-42c0-8b8b-79bb117b2cd12025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Athletes Foot UltraBUTENAFINE HYDROCHLORIDEH E B0841f741-6409-4d93-a6a7-901808f77bcd2025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Athletes Foot UltraBUTENAFINE HYDROCHLORIDEWal-Mart Stores Inca77a2694-04e7-4b37-ac6a-34f8969459122025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Butenafine Hydrochloride 1%BUTENAFINE HYDROCHLORIDECVS Pharmacy83830b24-bc94-4764-a6ca-3193abd9de662025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Butenafine Hydrochloride Athletes FootBUTENAFINE HYDROCHLORIDEKroger Company2af91428-3fb9-4974-a55f-87aad750d05b2025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Butenafine HydrochlorideBUTENAFINE HYDROCHLORIDEAlbertsons098dee89-0f7b-4341-a691-bfe6077ff3532025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Butenafine Hydrochloride Jock ItchBUTENAFINE HYDROCHLORIDEWal-Mart Stores Incbe9a411c-55d7-4db5-a420-30013efbbc242025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Jock Itch CreamBUTENAFINE HYDROCHLORIDETARGET CORPORATION1d8a17ae-4e25-f591-e063-6394a90a35dd2025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181
Jock ItchBUTENAFINE HYDROCHLORIDEWalgreen Company6b13e8ad-b7dd-49e7-9469-3cac077c763e2025-07-03WarningsExact identifier
application applno (ANDA): 205181
application number: ANDA205181

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298448butenafine HCl 1 % Topical CreamPSN14a23a39-b567-4db4-bac0-c008c0ca61716
1298448butenafine hydrochloride 10 MG/ML Topical CreamSCD14a23a39-b567-4db4-bac0-c008c0ca61716
1298448butenafine HCl 1 % Topical CreamSY14a23a39-b567-4db4-bac0-c008c0ca61716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2101-8516722101081 TUBE in 1 CARTON (51672-2101-8) > 12 g in 1 TUBE1 tube2017-11-170000-00-00NoNoCurrent