Home NDC 11523-4339 Lotrimin Ultra
Product NDC 11523-4339
11-digit product format 115234339
Labeler code 11523
Product ID 11523-4339_45370735-3f9d-a7f8-e063-6294a90aa0c6
Type HUMAN OTC DRUG
Nonproprietary name Butenafine hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Bayer Healthcare LLC.
Application NDA021307
Marketing category NDA
Marketing start 2002-02-22
Substance BUTENAFINE HYDROCHLORIDE
Active strength 1 g/100g
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 N021307-001 LOTRIMIN ULTRA BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL RLD, RS 2001-12-07
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 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Lotrimin Ultra
Brand name suffix Jock Itch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTENAFINE HYDROCHLORIDE 1 g/100g
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11523-4339-1 Lotrimin UltraJock Itch 1 in 1 CARTON CREAM 1 9 11523-4339-1 Lotrimin UltraJock Itch 12 g in 1 TUBE CREAM 12 9 11523-4339-2 Lotrimin UltraJock Itch 15 g in 1 TUBE CREAM 15 9 11523-4339-2 Lotrimin UltraJock Itch 1 in 1 CARTON CREAM 1 9 11523-4339-3 Lotrimin UltraJock Itch 1 in 1 CARTON CREAM 1 9 11523-4339-3 Lotrimin UltraJock Itch 30 g in 1 TUBE CREAM 30 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-4339 LOTRIMIN ULTRA JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [BAYER HEALTHCARE LLC.] 8 Current NDC, Legacy NDC, 6 package rows 20241208_9dfa08fb-0913-4326-b1eb-1425df6a2c82.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 · 4 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 11523-4339-1 11523433901 1 TUBE in 1 CARTON (11523-4339-1) / 12 g in 1 TUBE 1 tube 2002-02-22 0000-00-00 No No Current 11523-4339-2 11523433902 1 TUBE in 1 CARTON (11523-4339-2) / 15 g in 1 TUBE 1 tube 2002-02-22 0000-00-00 No No Current 11523-4339-3 11523433903 1 TUBE in 1 CARTON (11523-4339-3) / 30 g in 1 TUBE 1 tube 2023-09-26 No No Current