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 5 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Neighbor Pharmacy Clotrimazole 3	CLOTRIMAZOLE	AmerisourceBergen	2a7c3bd5-0ff4-46d2-b5d1-ef8637d0f530	2025-07-28	Warnings	Name fallback generic name: CLOTRIMAZOLE
Rugby Clotrimazole Antifungal Cream	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	bd567e91-7152-4612-83e0-8e8a00c2d2c5	2025-07-25	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	STRATEGIC SOURCING SERVICES LLC	8c7cc657-28a1-4720-97ce-098207bfc470	2025-07-21	Warnings	Name fallback generic name: CLOTRIMAZOLE
sunmark Clotrimazole 3	CLOTRIMAZOLE	Strategic Sourcing Services LLC	0bc5d91a-c4ea-4fe9-80e0-6f76aa073e7b	2025-07-21	Warnings	Name fallback generic name: CLOTRIMAZOLE
CVS Pharmacy Clotrimazole 3	CLOTRIMAZOLE	CVS Pharmacy	37000f9c-a1a4-4e5a-80c8-c9a1b2490a71	2025-07-17	Warnings	Name fallback generic name: CLOTRIMAZOLE
TopCare Antifungal	CLOTRIMAZOLE	Topco Associates LLC	6757eb2a-73e0-4bd0-a332-5713fdf3445d	2025-07-16	Warnings	Name fallback generic name: CLOTRIMAZOLE
UpandUp Clotrimazole	CLOTRIMAZOLE	Target Corporation	cb2b7d38-9988-493b-9843-56c2f59eed2f	2025-07-16	Warnings	Name fallback generic name: CLOTRIMAZOLE
Jock Itch	CLOTRIMAZOLE	TARGET Corporation	1ae551e7-69de-4eef-b4f7-5e1a880e631d	2025-07-16	Warnings	Name fallback generic name: CLOTRIMAZOLE
Athletes Foot	CLOTRIMAZOLE	FRED'S, INC.	d2d8f44e-2dfa-446b-855e-86e0d6d2d0df	2025-07-15	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole Jock Itch	CLOTRIMAZOLE	Rite Aid Corporation	c2875c05-eedd-4546-89dd-ed88b3f28abd	2025-07-14	Warnings	Name fallback generic name: CLOTRIMAZOLE
Signature Care Jock Itch	CLOTRIMAZOLE	Safeway Inc.	9ec8b527-0f03-4433-8d33-635e746fdf79	2025-07-14	Warnings	Name fallback generic name: CLOTRIMAZOLE
Ringworm	CLOTRIMAZOLE	Walgreen Company	42ee3ebc-4d8f-4ece-950d-5636699a2b2e	2025-07-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
Walgreens Jock Itch	CLOTRIMAZOLE	Walgreen Company	2d6d7ac8-9f62-4670-9aa2-e73c29034de9	2025-07-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Walgreen Company	5cc1c525-8ff2-429b-97ec-129e0100db47	2025-07-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
Live Better Antifungal	CLOTRIMAZOLE	The Great Atlantic & Pacific Tea Company	7b2e44b9-b1ac-48c8-994d-4e9682ec8bad	2025-07-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
CVS Antifungal Ringworm	CLOTRIMAZOLE	CVS Pharmacy	638c7fd6-cec4-4c14-9f49-de5658721199	2025-07-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
CVS Pharmacy ITCH RELIEF ANTIFUNGAL	CLOTRIMAZOLE	CVS Pharmacy	68163ef4-d23d-43ac-bb52-9b4ba3cba2d0	2025-07-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
HEB Antifungal	CLOTRIMAZOLE	H E B	8f07dc5a-cfa8-4a57-ac90-552a7c947cc5	2025-07-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
Publix athletic foot	CLOTRIMAZOLE	Publix Super Markets Inc	a51679aa-5dd4-404a-98cf-cc620e233cb8	2025-07-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
Terrasil Athletes Foot AntiFungal Treatment Max	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	fce478a0-05f5-4606-82ce-c8dd095df211	2025-07-11	Warnings	Name fallback generic name: CLOTRIMAZOLE

Reported adverse events (FAERS/openFDA)#

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