Application 018888

Type: NDA
Sponsor: MEDTECH PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MONISTAT 3	MICONAZOLE NITRATE	SUPPOSITORY;VAGINAL	200MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N018888-001	MONISTAT 3	MICONAZOLE NITRATE	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N018888-001	AB

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N018888-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018888-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018888-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018888-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018888-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018888-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018888-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018888-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018888-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018888-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018888-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018888-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018888-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018888-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018888-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018888-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018888-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018888-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018888-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018888-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018888-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018888-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018888-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018888-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018888-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018888-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018888-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018888-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018888-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018888-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018888-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018888-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018888-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018888-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018888-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018888-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018888-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018888-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018888-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018888-001	AB	1	`f41ea6bd6efb…`

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 5 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GOOD SENSE MICONAZOLE 3	MICONAZOLE NITRATE	L. Perrigo Company	906dcf48-63d8-44cf-a699-d1f30c84a029	2025-11-29	Warnings	Name fallback generic name: MICONAZOLE NITRATE
PiYanPing Antifungal	MICONAZOLE NITRATE	Zhejiang Dingtai Pharmaceutical Co., Ltd	840364aa-d799-4163-a9e8-3f10c18f86ae	2025-11-10	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Medline	MICONAZOLE NITRATE	Medline Industries, LP	1ea444eb-f2f5-8c63-e063-6294a90acac8	2025-11-06	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Anti-Fungal Powder	MICONAZOLE NITRATE	TopCo Associates	19c3fbc5-abde-57df-e063-6394a90a125c	2025-11-06	Warnings	Name fallback generic name: MICONAZOLE NITRATE
dg health miconazole 3	MICONAZOLE NITRATE	Dolgencorp Inc	d84aa78d-b408-4d51-a54c-c66f6cef33f1	2025-11-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 3	MICONAZOLE NITRATE	Safeway	b32aec61-32c0-4c7f-b843-348243332583	2025-11-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE
VAGISTAT 3	MICONAZOLE NITRATE	Combe Incorporated	e15a28cd-9e64-4e9e-8df9-829d84f1816c	2025-11-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Anti-fungal Powder Miconazole Nitrate	MICONAZOLE NITRATE	Meijer Distribution Inc	03fd069d-685d-b8ac-e063-6394a90a31f8	2025-10-31	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 3	MICONAZOLE NITRATE	H E B	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	2025-10-31	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Azolen	MICONAZOLE NITRATE	Stratus Pharmaceuticals, Inc.	9c2574f3-3be4-405a-9c87-943dc6ef8777	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazorb AF	MICONAZOLE NITRATE	AmerisourceBergen Drug Corporation	13a20d21-42d5-fe56-e063-6394a90aaf57	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Liquid Continuous	MICONAZOLE NITRATE	Family Dollar Services, Inc	17cc4601-f946-df8b-e063-6394a90a3897	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
HEB Athlete Foot Antifungal	MICONAZOLE NITRATE	HEB	2e204111-b5d3-0220-e063-6294a90a67bb	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Anti-Fungal Powder	MICONAZOLE NITRATE	The Kroger Co.	209cd0ed-3029-9137-e063-6394a90aa93d	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Miconazole Liquid Continuous	MICONAZOLE NITRATE	Meijer Distribution Inc	030f2a31-334b-a6d8-e063-6394a90a98fc	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Jock Itch	MICONAZOLE NITRATE	Meijer Distribution Inc.	030f1316-ab3c-ce37-e063-6394a90a0f88	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Athletes Foot	MICONAZOLE NITRATE	Meijer Distribution Inc	030f2a31-3357-a6d8-e063-6394a90a98fc	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Remedy Antifungal	MICONAZOLE NITRATE	Medline Industries, LP	021b4a31-d7f6-4921-b4b1-cbe832eecd93	2025-10-29	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Anti-fungal Powder Miconazole Nitrate	MICONAZOLE NITRATE	Premier Brands of America Inc.	052d8d02-2381-1e3a-e063-6394a90aa07e	2025-10-29	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Monistat 3 Combination Pack	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	e1b8ad40-5adb-482a-b532-3f8e30d90128	2025-10-27	Warnings	Name fallback generic name: MICONAZOLE NITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.