Clotrimazole

Product NDC: 73581-450
11-digit product format: 735810450
Labeler code: 73581
Product ID: 73581-450_53472e56-6294-f22e-e063-6294a90a833c
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: VAGINAL
Labeler: YYBA CORP
Application: ANDA072641
Marketing category: ANDA
Marketing start: 2026-09-01
Substance: CLOTRIMAZOLE
Active strength: 1 g/100g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A072641-001	CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM / VAGINAL			1995-12-04

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Clotrimazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G07GZ97H65	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309368	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
53472e4c-868f-18f5-e063-6394a90abce7	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	YYBA CORP	53472e4c-868f-18f5-e063-6394a90abce7	2026-09-01	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641 ndc (product): 73581-450
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals, Inc.	624827d6-dbf8-4f3d-a8c0-c92474cad7de	2026-03-31	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	bac80746-5cc3-4910-a0af-d43b8242acc6	2026-01-29	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641
Clotrimazole	CLOTRIMAZOLE	STRATEGIC SOURCING SERVICES LLC	8c7cc657-28a1-4720-97ce-098207bfc470	2025-07-21	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	f7192955-8f8c-45dd-a215-8ac2c1f6444f	2025-06-12	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G07GZ97H65	CLOTRIMAZOLE	23593-75-1	CLOTRIMAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73581-450-01	73581045001	1 TUBE in 1 CARTON (73581-450-01) / 45 g in 1 TUBE	1 tube	2026-09-01	No	No	Current