Lotrimin Ultra

Product NDC: 11523-0082
11-digit product format: 115230082
Labeler code: 11523
Product ID: 11523-0082_4526ca36-993f-b574-e063-6294a90a8fba
Type: HUMAN OTC DRUG
Nonproprietary name: Butenafine hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Bayer Healthcare LLC.
Application: NDA021307
Marketing category: NDA
Marketing start: 2021-12-20
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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`84e616aacf4f…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lotrimin Ultra
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d11dfdf6-9b36-03bc-e053-2995a90a0bc3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11523-0082-1	Lotrimin Ultra	20 g in 1 TUBE, WITH APPLICATOR	CREAM	20		7
11523-0082-1	Lotrimin Ultra	1 in 1 CARTON	CREAM	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-0082	LOTRIMIN ULTRA (BUTENAFINE HYDROCHLORIDE) CREAM [BAYER HEALTHCARE LLC.]	6	Current NDC, Legacy NDC, 2 package rows	20241208_d11dfdf6-9b36-03bc-e053-2995a90a0bc3.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lotrimin Ultra Jock Itch	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	9dfa08fb-0913-4326-b1eb-1425df6a2c82	2025-12-05	Warnings	Exact identifier application applno (NDA): 021307 application number: NDA021307
Lotrimin Ultra Athletes Foot	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	e258c4ac-53ef-4a99-b732-4985f890b938	2025-12-05	Warnings	Exact identifier application applno (NDA): 021307 application number: NDA021307
Lotrimin Ultra	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	d11dfdf6-9b36-03bc-e053-2995a90a0bc3	2025-12-04	Warnings	Exact identifier application applno (NDA): 021307 application number: NDA021307 ndc (product): 11523-0082
Lotrimin Ultra Ringworm	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	1b438ca7-fd5f-62cb-e063-6294a90ab3a6	2025-12-04	Warnings	Exact identifier application applno (NDA): 021307 application number: NDA021307

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R8XA2029ZI	BUTENAFINE HYDROCHLORIDE	101827-46-7	BUTENAFINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1298448	butenafine HCl 1 % Topical Cream	PSN	d11dfdf6-9b36-03bc-e053-2995a90a0bc3	7
1298448	butenafine hydrochloride 10 MG/ML Topical Cream	SCD	d11dfdf6-9b36-03bc-e053-2995a90a0bc3	7
1298448	butenafine HCl 1 % Topical Cream	SY	d11dfdf6-9b36-03bc-e053-2995a90a0bc3	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
11523-0082-1	11523008201	1 TUBE, WITH APPLICATOR in 1 CARTON (11523-0082-1) / 20 g in 1 TUBE, WITH APPLICATOR	2021-12-20	0000-00-00	No	No	Current