Clotrimazole

Product NDC: 70000-0729
Requested package NDC: 70000-0729-1
11-digit product format: 700000729
Labeler code: 70000
Product ID: 70000-0729_2bf37309-fa5f-470b-98c2-e0b078c9e2fd
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: VAGINAL
Labeler: Cardinal Health (Leader) 70000
Application: ANDA074165
Marketing category: ANDA
Marketing start: 2025-04-30
Substance: CLOTRIMAZOLE
Active strength: 10 mg/g
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
A074165-001	CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM / VAGINAL		RS	1993-07-16

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 · 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	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`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	10 mg/g

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
4aaae616-179b-40f1-8a39-6a1ddd414070	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70000-0729-1	Clotrimazole	45 g in 1 TUBE	CREAM	45		1
70000-0729-1	Clotrimazole	1 in 1 BOX	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0729	CLOTRIMAZOLE CREAM [CARDINAL HEALTH (LEADER) 70000]	1	Current NDC, 2 package rows	20250430_4aaae616-179b-40f1-8a39-6a1ddd414070.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	Walgreens	7ca79361-6608-4eda-ba5b-16c28eb6c019	2026-06-09	Warnings	Exact identifier application applno (ANDA): 074165 application number: ANDA074165
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	80d67df3-843d-47bb-85a2-d2f26a824336	2026-03-31	Warnings	Exact identifier application applno (ANDA): 074165 application number: ANDA074165
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	fd010006-f646-46ed-841a-9f247b19e397	2026-03-31	Warnings	Exact identifier application applno (ANDA): 074165 application number: ANDA074165
Clotrimazole	CLOTRIMAZOLE	Strategic Sourcing Services LLC	de3b6b64-dfa5-4abd-ba43-4ab59b4c2284	2025-09-09	Warnings	Exact identifier application applno (ANDA): 074165 application number: ANDA074165
Clotrimazole	CLOTRIMAZOLE	Cardinal Health (Leader) 70000	4aaae616-179b-40f1-8a39-6a1ddd414070	2025-04-29	Warnings	Exact identifier application applno (ANDA): 074165 application number: ANDA074165 ndc (package): 70000-0729-1 ndc (product): 70000-0729 ndc11 (package): 70000072901
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	6b908538-d9ff-41d0-909c-01e1d1b21a39	2024-10-23	Warnings	Exact identifier application applno (ANDA): 074165 application number: ANDA074165
Clotrimazole	CLOTRIMAZOLE	QUALITY CHOICE (Chain Drug Marketing Association)	3c676ff0-44a8-40cd-8f85-d39dda3d9637	2024-05-23	Warnings	Exact identifier application applno (ANDA): 074165 application number: ANDA074165
Clotrimazole	CLOTRIMAZOLE	H2-Pharma, LLC	388f7e35-efbe-496b-a8d6-518caa22328d	2023-01-11	Warnings	Exact identifier application applno (ANDA): 074165 application number: ANDA074165

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309368	clotrimazole 1 % Vaginal Cream	PSN	4aaae616-179b-40f1-8a39-6a1ddd414070	1
309368	clotrimazole 10 MG/ML Vaginal Cream	SCD	4aaae616-179b-40f1-8a39-6a1ddd414070	1
309368	clotrimazole 1 % Vaginal Cream	SY	4aaae616-179b-40f1-8a39-6a1ddd414070	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70000-0729-1	70000072901	1 TUBE in 1 BOX (70000-0729-1) / 45 g in 1 TUBE	1 tube	2025-04-30	No	No	Current