Application 018183

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCELEX	CLOTRIMAZOLE	CREAM;TOPICAL	1%	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
N018183-001	MYCELEX	CLOTRIMAZOLE	1%	CREAM / TOPICAL		Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018183-001	MYCELEX	1%	CREAM / TOPICAL	Approved before 1982	`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 2 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOTRIMAZOLE	CLOTRIMAZOLE	Rugby Laboratories, Inc.	2c60e631-5930-4420-886d-eb1990c720b6	2026-05-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	c0f58a0d-a304-41f9-bbdf-c2e488230cf0	2026-05-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Akron Pharma Inc	692d7e0f-50d4-4abb-8c74-36bc98064fe7	2026-05-05	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	KJD Pharma Private Limited	5115f8e3-5668-5207-e063-6394a90a7650	2026-05-05	Warnings	Name fallback generic name: CLOTRIMAZOLE
FifthPulse Clotrimazole Antifungal	CLOTRIMAZOLE	WeCare Products LLC	9f5ea297-5a25-42cc-bd47-4159108b0023	2026-04-27	Warnings	Name fallback generic name: CLOTRIMAZOLE
SimplyVital Antifungal Clotrimazole	CLOTRIMAZOLE	Alpha Plants Inc	44881106-3ab4-4103-9c48-1da435ab5b13	2026-04-16	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	70e1efac-1738-43db-b19c-bbe02810b6e7	2026-04-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
RUGBY ANTIFUNGAL CLOTRIMAZOLE	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	caba588a-13df-4035-ac41-6b4ec90cd88d	2026-04-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	80d67df3-843d-47bb-85a2-d2f26a824336	2026-03-31	Warnings	Name fallback generic name: CLOTRIMAZOLE
RoyceDerm Antifungal Bar	CLOTRIMAZOLE	RoyceDerm LLC	3abdc4a8-58dd-5bd0-e063-6294a90a1bca	2026-03-31	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals, Inc.	624827d6-dbf8-4f3d-a8c0-c92474cad7de	2026-03-31	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	fd010006-f646-46ed-841a-9f247b19e397	2026-03-31	Warnings	Name fallback generic name: CLOTRIMAZOLE
Antifungal	CLOTRIMAZOLE	Dynarex Corporation	4d4cc4b4-c0b4-9e25-e063-6294a90a70b8	2026-03-18	Warnings	Name fallback generic name: CLOTRIMAZOLE
CLOTIC (clotrimazole) otic solution	CLOTRIMAZOLE	Carwin Pharmaceutical Associates, LLC	ef0658c3-9c6b-4705-89d8-cf0644c80fcb	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	TRIFECTA PHARMACEUTICALS USA LLC	e0a2a907-9c3a-4c4e-e053-2995a90abb91	2026-03-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
CLOTRIMAZOLE	CLOTRIMAZOLE	AARNA USA INC	4bd825f4-f5e2-aab7-e063-6394a90ad6a4	2026-02-27	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
Megababe Fun Gal Stuff Antifungal	CLOTRIMAZOLE	Megababe LLC	c599d27b-fdb0-465f-9e43-13d32c520a92	2026-02-25	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	d6f5c6b5-5e56-462f-8c47-7986ce53669d	2026-02-25	Warnings	Name fallback generic name: CLOTRIMAZOLE
Kerova ANTIFUNGAL	CLOTRIMAZOLE	Guangzhou Bixiaoyu Trading Co., Ltd.	4a7b48cf-72c3-be63-e063-6394a90a1efe	2026-02-10	Warnings	Name fallback generic name: CLOTRIMAZOLE
CLOTRIMAZOLE 1%	CLOTRIMAZOLE	PHARMACY CHOICE INC	43852cfb-6d28-e54f-e063-6394a90aa090	2026-02-08	Warnings	Name fallback generic name: CLOTRIMAZOLE

Reported adverse events (FAERS/openFDA)#

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