Home NDC 51672-2101 Jock Itch
Product NDC 51672-2101
11-digit product format 516722101
Labeler code 51672
Product ID 51672-2101_3907ca33-83bf-59c5-e063-6294a90a6aaa
Type HUMAN OTC DRUG
Nonproprietary name Butenafine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA205181
Marketing category ANDA
Marketing start 2017-11-17
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205181-001 BUTENAFINE HYDROCHLORIDE BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Jock Itch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTENAFINE HYDROCHLORIDE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R8XA2029ZI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1298448 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-2101 JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 4 Current NDC, Legacy NDC, 8 package rows 20171121_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 · 18 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-2101-1 51672210101 1 TUBE in 1 CARTON (51672-2101-1) / 15 g in 1 TUBE 1 tube 2017-11-17 0000-00-00 No No Current 51672-2101-2 51672210102 1 TUBE in 1 CARTON (51672-2101-2) / 30 g in 1 TUBE 1 tube 2017-11-17 0000-00-00 No No Current 51672-2101-8 51672210108 1 TUBE in 1 CARTON (51672-2101-8) / 12 g in 1 TUBE 1 tube 2017-11-17 0000-00-00 No No Current 51672-2101-9 51672210109 1 TUBE in 1 CARTON (51672-2101-9) / 24 g in 1 TUBE 1 tube 2017-11-17 0000-00-00 No No Current