FDA.reportPublic FDA data

Butenafine Hydrochloride

Product NDC
30142-210
11-digit product format
301420210
Labeler code
30142
Product ID
30142-210_39077171-1296-7988-e063-6394a90a0f13
Type
HUMAN OTC DRUG
Nonproprietary name
Butenafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Kroger Company
Application
ANDA205181
Marketing category
ANDA
Marketing start
2017-11-16
Substance
BUTENAFINE HYDROCHLORIDE
Active strength
10 mg/g
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 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
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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205181-001BUTENAFINE 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…
2022-10-28 04:53 UTC2022-10A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Butenafine Hydrochloride
Brand name suffix
Athletes Foot
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTENAFINE HYDROCHLORIDE10 mg/g

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
2af91428-3fb9-4974-a55f-87aad750d05bAvailable on FDA.report

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
30142-210-02Butenafine Hydrochloride Athletes Foot30 g in 1 TUBECREAM303
30142-210-02Butenafine Hydrochloride Athletes Foot1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-210BUTENAFINE HYDROCHLORIDE ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]2Current NDC, Legacy NDC, 2 package rows20190329_2af91428-3fb9-4974-a55f-87aad750d05b.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 HydrochlorideBUTENAFINE HYDROCHLORIDEMEIJER DISTRIBUTION INC4e88068b-1449-43b4-9c7c-4ad8e877459b2025-07-03WarningsExact 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
ndc (product): 30142-210
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 ItchBUTENAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.14a23a39-b567-4db4-bac0-c008c0ca61712025-07-03WarningsExact 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 CreamPSN2af91428-3fb9-4974-a55f-87aad750d05b3
1298448butenafine hydrochloride 10 MG/ML Topical CreamSCD2af91428-3fb9-4974-a55f-87aad750d05b3
1298448butenafine HCl 1 % Topical CreamSY2af91428-3fb9-4974-a55f-87aad750d05b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-210-02301420210021 TUBE in 1 CARTON (30142-210-02) / 30 g in 1 TUBE1 tube2021-03-210000-00-00NoNoCurrent