Clotrimazole

Product NDC: 70677-1262
11-digit product format: 706771262
Labeler code: 70677
Product ID: 70677-1262_3a767c0f-29db-c885-e063-6394a90aae7a
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: VAGINAL
Labeler: STRATEGIC SOURCING SERVICES LLC
Application: ANDA072641
Marketing category: ANDA
Marketing start: 2024-11-07
Substance: CLOTRIMAZOLE
Active strength: 1 g/100g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [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
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: 2026-12-31

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
8c7cc657-28a1-4720-97ce-098207bfc470	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
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
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
70677-1262-1	Clotrimazole	45 g in 1 TUBE	CREAM	45		3
70677-1262-1	Clotrimazole	1 in 1 CARTON	CREAM	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70677-1262-1	GM - Gram	70677-1262	4223c97b-743a-4b2c-ba87-e1f879427a26	1	2025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70677-1262	CLOTRIMAZOLE CREAM [STRATEGIC SOURCING SERVICES LLC]	2	Current NDC, 2 package rows	20241116_8c7cc657-28a1-4720-97ce-098207bfc470.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 · 6 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
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 ndc (product): 70677-1262
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	f7192955-8f8c-45dd-a215-8ac2c1f6444f	2025-06-12	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641
Clotrimazole	CLOTRIMAZOLE	NuCare Pharmaceuticals,Inc.	ab0e14b8-8c64-435c-e053-2a95a90acfba	2024-07-17	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309368	clotrimazole 1 % Vaginal Cream	PSN	8c7cc657-28a1-4720-97ce-098207bfc470	3
309368	clotrimazole 10 MG/ML Vaginal Cream	SCD	8c7cc657-28a1-4720-97ce-098207bfc470	3
309368	clotrimazole 1 % Vaginal Cream	SY	8c7cc657-28a1-4720-97ce-098207bfc470	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70677-1262-1	70677126201	1 TUBE in 1 CARTON (70677-1262-1) / 45 g in 1 TUBE	1 tube	2024-11-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole Vaginal Cream USP 1%	STRATEGIC SOURCING SERVICES LLC \| Sun Pharma Canada Inc.	2025-07-21	HUMAN OTC DRUG LABEL	3