TopCare

Product NDC: 36800-062
11-digit product format: 368000062
Labeler code: 36800
Product ID: 36800-062_9cf4438c-40a4-4cba-8d4d-f8f6095f38e8
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: VAGINAL
Labeler: Topco Associates LLC
Application: NDA021143
Marketing category: NDA
Marketing start: 2000-04-12
Marketing end: 0000-00-00
Substance: CLOTRIMAZOLE
Active strength: 2 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	36800-062		I	Inactivated by FDA		2026-08-11
excluded package	package	36800-062	36800-062-00	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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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	36800-062-00	`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
N021143-001	TRIVAGIZOLE 3	CLOTRIMAZOLE	2%	CREAM / VAGINAL			2000-04-12

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	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
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
36800-062-00	2020-01-31	C162847	48780-1	9d75b9cf-e435-f424-e053-dadaa90a57ce	TopCare ® Clotrimazole 3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-062-00	TopCare Clotrimazole 3	21 g in 1 TUBE, WITH APPLICATOR	CREAM	21		1
36800-062-00	TopCare Clotrimazole 3	1 in 1 CARTON	CREAM	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-062-00	GM - Gram	36800-062	95a4808e-1078-42d0-9176-3a6e736eec91	1	2020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Clotrimazole	ACTIVE INGREDIENT	G07GZ97H65	TOPCARE CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC]	1
Clotrimazole	ACTIVE MOIETY	G07GZ97H65	TOPCARE CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	TOPCARE CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	TOPCARE CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC]	1
cetyl esters wax	INACTIVE INGREDIENT	D072FFP9GU	TOPCARE CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC]	1
octyldodecanol	INACTIVE INGREDIENT	461N1O614Y	TOPCARE CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	TOPCARE CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	TOPCARE CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-062	TOPCARE CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [TOPCO ASSOCIATES LLC]	1	Legacy NDC, 2 package rows	20130110_2970c5f2-282e-4b22-8e24-331c959f0e3e.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	Foster and Thrive (Mckesson /STRATEGIC SOURCING SERVICES LLC)	474f5446-f9e3-4422-a9da-c7e23aaa0941	2025-07-30	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143
Good Neighbor Pharmacy Clotrimazole 3	CLOTRIMAZOLE	AmerisourceBergen	2a7c3bd5-0ff4-46d2-b5d1-ef8637d0f530	2025-07-28	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143
sunmark Clotrimazole 3	CLOTRIMAZOLE	Strategic Sourcing Services LLC	0bc5d91a-c4ea-4fe9-80e0-6f76aa073e7b	2025-07-21	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143
CVS Pharmacy Clotrimazole 3	CLOTRIMAZOLE	CVS Pharmacy	37000f9c-a1a4-4e5a-80c8-c9a1b2490a71	2025-07-17	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143
Walgreens Clotrimazole 3	CLOTRIMAZOLE	Walgreen Company	7fafdebd-b117-4a6b-a499-a4d3ac086ab9	2025-07-08	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	325a40b0-3e17-47c6-8988-d5396ca5d53f	2025-07-02	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143

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
199603	clotrimazole 2 % Vaginal Cream	PSN	2970c5f2-282e-4b22-8e24-331c959f0e3e	1
199603	clotrimazole 20 MG/ML Vaginal Cream	SCD	2970c5f2-282e-4b22-8e24-331c959f0e3e	1
199603	clotrimazole 2 % Vaginal Cream	SY	2970c5f2-282e-4b22-8e24-331c959f0e3e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
36800-062-00	36800006200	21 g in 1 TUBE, WITH APPLICATOR	21 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TopCare ® Clotrimazole 3	Topco Associates LLC \| Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceuticals Inc.	2013-01-07	HUMAN OTC DRUG LABEL	1