Clotrimazole

Product NDC: 68788-9665
11-digit product format: 687889665
Labeler code: 68788
Product ID: 68788-9665_61f64e2c-533a-4712-8c95-fb2fbf37c054
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: VAGINAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA072641
Marketing category: ANDA
Marketing start: 2013-08-05
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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`cb3db0bc1861…`

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
624827d6-dbf8-4f3d-a8c0-c92474cad7de	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
68788-9665-4	Clotrimazole	45 g in 1 TUBE	CREAM	45		9
68788-9665-4	Clotrimazole	1 in 1 CARTON	CREAM	1		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Clotrimazole	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	1
Clotrimazole	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	1
cetyl esters wax	INACTIVE INGREDIENT	D072FFP9GU	CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	1
octyldodecanol	INACTIVE INGREDIENT	461N1O614Y	CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-9665	CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250309_624827d6-dbf8-4f3d-a8c0-c92474cad7de.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals, Inc.	624827d6-dbf8-4f3d-a8c0-c92474cad7de	2026-03-31	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641 ndc (product): 68788-9665
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
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	624827d6-dbf8-4f3d-a8c0-c92474cad7de	9
309368	clotrimazole 10 MG/ML Vaginal Cream	SCD	624827d6-dbf8-4f3d-a8c0-c92474cad7de	9
309368	clotrimazole 1 % Vaginal Cream	SY	624827d6-dbf8-4f3d-a8c0-c92474cad7de	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-9665-4	68788966504	1 TUBE in 1 CARTON (68788-9665-4) / 45 g in 1 TUBE	1 tube	2013-08-05	0000-00-00	No	No	Current