Clotrimazole

Product NDC: 76413-305
11-digit product format: 764130305
Labeler code: 76413
Product ID: 76413-305_6dbc10cc-a719-45c8-874f-1de2a484123d
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: VAGINAL
Labeler: Central Texas Community Health Centers
Application: ANDA072641
Marketing category: ANDA
Marketing start: 1995-12-04
Marketing end: 0000-00-00
Substance: CLOTRIMAZOLE
Active strength: 1 g/100g
NDC exclude flag: No
Listing certified through: 2019-12-31
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	76413-305		I	Inactivated by FDA		2026-08-11
excluded package	package	76413-305	76413-305-45	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76413-305-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76413-305-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76413-305-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76413-305-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76413-305-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76413-305-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76413-305-45	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76413-305-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76413-305-45	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76413-305-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76413-305-45	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76413-305-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76413-305-45	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76413-305-45	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76413-305-45	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76413-305-45	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76413-305-45	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76413-305-45	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76413-305-45	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76413-305-45	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	76413-305-45	`9bebd1f3094a…`	`5416666fcb17…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76413-305-45	2020-01-31	C162847	48780-1	9d75b9d1-1d6d-f424-e053-dadaa90a57ce	Clotrimazole

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76413-305-45	Clotrimazole	1 in 1 CARTON	CREAM	1		1
76413-305-45	Clotrimazole	45 g in 1 TUBE	CREAM	45		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76413-305	CLOTRIMAZOLE CREAM [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]	1	Legacy NDC, 2 package rows	20171129_b1a02eef-35f0-4d68-8ee4-0a7357bde00c.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
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	b1a02eef-35f0-4d68-8ee4-0a7357bde00c	1
309368	clotrimazole 10 MG/ML Vaginal Cream	SCD	b1a02eef-35f0-4d68-8ee4-0a7357bde00c	1
309368	clotrimazole 1 % Vaginal Cream	SY	b1a02eef-35f0-4d68-8ee4-0a7357bde00c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
76413-305-45	76413030545	1 in 1 CARTON	Historical