FDA.reportPublic FDA data

Butenafine Hydrochloride 1%

Product NDC
69842-989
11-digit product format
698420989
Labeler code
69842
Product ID
69842-989_39077171-1285-7988-e063-6394a90a0f13
Type
HUMAN OTC DRUG
Nonproprietary name
Butenafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy
Application
ANDA205181
Marketing category
ANDA
Marketing start
2018-10-18
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 1%
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
83830b24-bc94-4764-a6ca-3193abd9de66Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-989-08Butenafine Hydrochloride 1%12 g in 1 TUBECREAM123
69842-989-08Butenafine Hydrochloride 1%1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-989-08GM - Gram69842-9892cb24024-db55-40e8-bf78-68144fcf9de012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-989BUTENAFINE HYDROCHLORIDE 1% (BUTENAFINE HYDROCHLORIDE) CREAM [CVS PHARMACY]2Current NDC, Legacy NDC, 2 package rows20230414_83830b24-bc94-4764-a6ca-3193abd9de66.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
ndc (product): 69842-989
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 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 CreamPSN83830b24-bc94-4764-a6ca-3193abd9de663
1298448butenafine hydrochloride 10 MG/ML Topical CreamSCD83830b24-bc94-4764-a6ca-3193abd9de663
1298448butenafine HCl 1 % Topical CreamSY83830b24-bc94-4764-a6ca-3193abd9de663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-989-08698420989081 TUBE in 1 CARTON (69842-989-08) / 12 g in 1 TUBE1 tube2018-10-180000-00-00NoNoCurrent