Application 018182

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MYCELEX-7	CLOTRIMAZOLE	TABLET;VAGINAL	100MG	No	No

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
N018182-002	MYCELEX-7	CLOTRIMAZOLE	100MG	TABLET / VAGINAL			1991-12-26

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`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 3 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	Glenmark Pharmaceuticals Inc., USA	f6898117-14f3-42d2-bc0e-d296add3ad70	2026-01-30	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
Jock Itch Clotrimazole Antifungal	CLOTRIMAZOLE	WalMart	a7677ad4-5239-40da-809a-501b91caedbf	2026-01-29	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	bac80746-5cc3-4910-a0af-d43b8242acc6	2026-01-29	Warnings	Name fallback generic name: CLOTRIMAZOLE
clotrimazole	CLOTRIMAZOLE	Padagis Israel Pharmaceuticals Ltd	3dcd0158-ec51-4fa7-a26a-02c2926156c0	2026-01-22	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	The Podiatree Company	68a4e3f5-f84d-5650-e053-2a91aa0a171d	2026-01-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	The Podiatree Company	79234400-0766-792c-e053-2a91aa0a6e6d	2026-01-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Fortinia	CLOTRIMAZOLE	The Podiatree Company	60ba6f8a-8617-d4f6-e053-2991aa0a4a71	2026-01-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole (Topical Solution), 1%	CLOTRIMAZOLE	Puro Pharma Inc.	cb424fa8-3ed5-45cd-b03f-64675584b34e	2025-12-27	Warnings	Name fallback generic name: CLOTRIMAZOLE
ElixirCurozole	CLOTRIMAZOLE	ELIXIR HEALTHCARE USA, LLC.	0c468a9e-d092-4704-b742-92ecd9918209	2025-12-26	Warnings	Name fallback generic name: CLOTRIMAZOLE
CLOTRIMAZOLE	CLOTRIMAZOLE	GRAXCELL PHARMACEUTICAL, LLC.	5f8ca6ad-cb25-1abf-e053-2a91aa0aca99	2025-12-25	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Granules USA, Inc.	6e63e29a-eb50-1790-e053-2a91aa0a3616	2025-12-22	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	RUGBY LABORATORIES	6de9155b-7070-38fd-e053-2a91aa0af6f6	2025-12-19	Warnings	Name fallback generic name: CLOTRIMAZOLE
Alevazol	CLOTRIMAZOLE	Capital Pharmaceutical, LLC	edd8da89-0b83-4de6-a166-7451d0084169	2025-12-12	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	1e7e74f6-9bca-48ab-804a-a7a81df3b608	2025-12-05	Warnings	Name fallback generic name: CLOTRIMAZOLE
Lotrimin	CLOTRIMAZOLE	Bayer HealthCare LLC.	b584e17f-ed43-43bd-b643-dfa48edd78c6	2025-12-05	Warnings	Name fallback generic name: CLOTRIMAZOLE
Fungicure Night Cream	CLOTRIMAZOLE	Kobayashi Healthcare International, Inc.	43029403-2afd-cfa1-e063-6394a90a99a3	2025-12-04	Warnings	Name fallback generic name: CLOTRIMAZOLE
Lotrimin Antifungal	CLOTRIMAZOLE	Bayer HealthCare LLC.	f9536683-3f32-4c71-9b6a-70f8611e3dcf	2025-12-04	Warnings	Name fallback generic name: CLOTRIMAZOLE
Lotrimin	CLOTRIMAZOLE	Bayer HealthCare LLC	da948ef3-3709-4bfc-9d17-f6f1ea325343	2025-12-04	Warnings	Name fallback generic name: CLOTRIMAZOLE
WELMATE Clotrimazole Topical Solution	CLOTRIMAZOLE	YYBA CORP	dc5bac4a-938c-4678-89ac-a899440c6a3c	2025-12-02	Warnings	Name fallback generic name: CLOTRIMAZOLE
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	0a6cb1f7-a2a2-46a2-ae63-d205318996f0	2025-12-01	Warnings	Name fallback generic name: CLOTRIMAZOLE

Reported adverse events (FAERS/openFDA)#

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