Clotrimazole

Product NDC: 63868-259
11-digit product format: 638680259
Labeler code: 63868
Product ID: 63868-259_77ae462c-38b6-4b2f-b0cf-3b6a168d0c4a
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: VAGINAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: ANDA074165
Marketing category: ANDA
Marketing start: 2014-10-15
Marketing end: 0000-00-00
Substance: CLOTRIMAZOLE
Active strength: 10 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63868-259		D	Discontinued by firm		2026-08-07
excluded package	package	63868-259	63868-259-15	D	Discontinued by firm		2026-08-07

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
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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074165-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	RS	1993-07-16	`cb3db0bc1861…`

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
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-259-15	GM - Gram	63868-259	e6e71505-e4ff-435f-acd3-663dc6347013	1	2022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOTRIMAZOLE	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]	3
CLOTRIMAZOLE	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	CLOTRIMAZOLE CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]	3
CETYL ESTERS WAX	INACTIVE INGREDIENT	D072FFP9GU	CLOTRIMAZOLE CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]	3
OCTYLDODECYL STEARATE	INACTIVE INGREDIENT	K6F16QGO28	CLOTRIMAZOLE CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]	3
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	CLOTRIMAZOLE CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]	3
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	CLOTRIMAZOLE CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]	3
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	CLOTRIMAZOLE CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-259	CLOTRIMAZOLE CREAM [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	11	Legacy NDC	20241102_cd3b71ad-eda6-43ed-8b7c-e75354f8610c.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 · 9 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	Rite Aid Corporation	384c8113-87aa-4fbd-942a-5f02c4e88536	2025-10-14	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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-259-15	63868025915	1 TUBE in 1 CARTON (63868-259-15) > 45 g in 1 TUBE	1 tube	2014-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole Vaginal Cream, USP	QUALITY CHOICE (Chain Drug Marketing Association)	2025-12-29	HUMAN OTC DRUG LABEL	12