Topcare Miconazole 7

Product NDC: 36800-825
11-digit product format: 368000825
Labeler code: 36800
Product ID: 36800-825_887383d2-df39-4e9f-9b11-4fa83dc578ce
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole nitrate
Dosage form: CREAM
Route: VAGINAL
Labeler: Topco Associates LLC
Application: ANDA074760
Marketing category: ANDA
Marketing start: 2000-02-29
Substance: MICONAZOLE NITRATE
Active strength: 2 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 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
A074760-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	2%	CREAM / VAGINAL			1997-05-15

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	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Topcare Miconazole 7
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VW4H1CYW1K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998540	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
351905b1-f78c-4838-a036-23b2bfc775f2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-825-29	Topcare Miconazole 7	45 g in 1 TUBE, WITH APPLICATOR	CREAM	45		4
36800-825-29	Topcare Miconazole 7	1 in 1 CARTON	CREAM	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-825-29	GM - Gram	36800-825	1a9045a2-8191-4ea4-8f83-bfcd12316fe0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	TOPCARE MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]	1
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	TOPCARE MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-825	TOPCARE MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [TOPCO ASSOCIATES LLC]	4	Current NDC, Legacy NDC, 2 package rows	20210211_351905b1-f78c-4838-a036-23b2bfc775f2.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense miconazole 7	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	9e0af5f8-249e-434a-a9c6-eb2f4045d9f6	2026-06-08	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
miconazole 7	MICONAZOLE NITRATE	HyVee Inc	53b9bcb3-ff43-4849-9f72-84febe255328	2026-06-04	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
MICONAZOLE 7	MICONAZOLE NITRATE	Safeway	2f19d76f-1348-483e-8720-612d30928bb5	2026-05-26	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Miconazole 7	MICONAZOLE NITRATE	Meijer Distribution Inc	b8417956-4c53-444e-823a-a87748eb0a08	2026-05-05	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
up and up miconazole 7	MICONAZOLE NITRATE	Target Corporation	b6216f21-4af8-40ab-8151-a9367a42b82c	2025-07-17	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
vagisil brand vagistat	MICONAZOLE NITRATE	Combe Incorporated	833a5e4d-0591-4300-8f9c-fd00ffaf6041	2025-04-15	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
miconazole 7	MICONAZOLE NITRATE	H E B	9741b8c0-716a-4c54-9793-387866faf766	2023-11-13	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
foster and thrive miconazole 7	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	b06590b5-1dcf-47b7-8e81-5887b1c3893a	2023-11-05	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
foster and thrive miconazole	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	09c4f6c9-ba51-47f4-95b4-d236fa45778b	2023-10-25	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Miconazole 7	MICONAZOLE NITRATE	Kroger Company	9fc3df65-c441-44ab-aaac-f63b565ca2f5	2023-09-13	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Equaline Miconazole 7	MICONAZOLE NITRATE	United Natural Foods, Inc. dba UNFI	7ebd51d9-8578-48c8-804a-e80fbe514fa1	2023-08-02	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Basic Care Miconazole 7	MICONAZOLE NITRATE	Amazon.com Services LLC	4a828083-f5a9-46c3-a07a-3d151f155025	2021-08-13	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
DG Health Miconazole	MICONAZOLE NITRATE	Dolgencorp, LLC	12a36975-ebfe-4fcb-a9de-981a21325632	2021-06-09	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Topcare Miconazole 7	MICONAZOLE NITRATE	Topco Associates LLC	351905b1-f78c-4838-a036-23b2bfc775f2	2021-02-08	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760 ndc (product): 36800-825
signature care miconazole 7	MICONAZOLE NITRATE	Safeway	2e04ac2d-cfbc-4261-a8f9-03715f819c1c	2021-02-08	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Good Neighbor Pharmacy Miconazole 7	MICONAZOLE NITRATE	Amerisource Bergen	5a3441e8-f4fc-404f-8e9e-6d2aee2b8cec	2021-01-27	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Good Sense Miconazole 7	MICONAZOLE NITRATE	L Perrigo Company	4902029e-47dd-483b-af03-b1b5936e98ea	2021-01-27	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
good sense miconazole 7	MICONAZOLE NITRATE	L. Perrigo Company	090ee644-7f73-4a43-aa5e-bfa74b0d5130	2021-01-06	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Careone miconazole 7	MICONAZOLE NITRATE	American Sales Company	fced0f7f-31b8-4975-836e-3f38c496a450	2021-01-06	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	MICONAZOLE NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998540	miconazole nitrate 2 % Vaginal Cream	PSN	351905b1-f78c-4838-a036-23b2bfc775f2	4
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	351905b1-f78c-4838-a036-23b2bfc775f2	4
998540	miconazole nitrate 2 % Vaginal Cream	SY	351905b1-f78c-4838-a036-23b2bfc775f2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-825-29	36800082529	1 TUBE, WITH APPLICATOR in 1 CARTON (36800-825-29) / 45 g in 1 TUBE, WITH APPLICATOR	2000-02-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Miconazole 7 Drug Facts	Topco Associates LLC	2021-02-08	HUMAN OTC DRUG LABEL	4