Home Applications 018183 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 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 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 · 41 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 2026-02-19 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…2022-09-29 23:25 UTC 2022-09 N018183-001 MYCELEX 1% CREAM / TOPICAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018183-001 MYCELEX 1% CREAM / TOPICAL Approved before 1982 cb3db0bc1861…
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 9 · 173 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clotrimazole CLOTRIMAZOLE Shaanxi Shuvita Biotech Co., Ltd 572a5f3d-fb46-5dfa-e063-6294a90a722b 2026-07-21 Warnings Name fallback generic name: CLOTRIMAZOLE Tea Tree Antifungal CLOTRIMAZOLE HONG KONG UNORDERED TRADING CO., LIMITED 56de35b7-b57d-1c62-e063-6294a90a757d 2026-07-18 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Preferred Pharmaceuticals Inc. c64e2290-593f-48a2-a15d-41689f836fda 2026-07-16 Warnings, Adverse reactions Name fallback generic name: CLOTRIMAZOLE terrasil Antifungal Cleansing Bar CLOTRIMAZOLE Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 10a4fde0-87e1-4474-bcb5-255b0a7f1ecb 2026-07-14 Warnings Name fallback generic name: CLOTRIMAZOLE Tinea Versicolor Treatment Cream CLOTRIMAZOLE Beautivity LLC 32d71d7e-3c78-6b63-e063-6294a90adaed 2026-06-29 Warnings Name fallback generic name: CLOTRIMAZOLE Tinea Versicolor Treatment Bar CLOTRIMAZOLE Beautivity LLC 33612382-2f12-e9f6-e063-6394a90aaee4 2026-06-29 Warnings Name fallback generic name: CLOTRIMAZOLE Tinea Versicolor Treatment Kit CLOTRIMAZOLE Beautivity LLC 3361d9a2-daf6-7749-e063-6294a90a3653 2026-06-29 Warnings Name fallback generic name: CLOTRIMAZOLE Terramed Just Think Comfort Clotrimazole Antifungal Topical Solution CLOTRIMAZOLE Rida LLC 83a9c5dc-c969-43a7-a763-44783710d5d0 2026-06-18 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Redpharm Drug 53cafc9f-7761-83a9-e063-6294a90a3437 2026-06-09 Warnings, Adverse reactions Name fallback generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Walgreens 7ca79361-6608-4eda-ba5b-16c28eb6c019 2026-06-09 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Sun Pharmaceutical Industries, Inc. 13a14d3c-bfce-42b5-8463-4ec69e94774e 2026-06-03 Warnings Name fallback generic name: CLOTRIMAZOLE Athletes Foot Cream CLOTRIMAZOLE Shenzhen Miandou Technology Co.,Ltd. 53451e74-719e-9499-e063-6394a90a9e5a 2026-06-02 Warnings Name fallback generic name: CLOTRIMAZOLE Medi-First Clotrimazole 1% ANTIFUNGAL Cream CLOTRIMAZOLE Unifirst First Aid Corporation 522eeb91-8378-32f4-e063-6394a90aff43 2026-05-20 Warnings Name fallback generic name: CLOTRIMAZOLE Fungicure Intensive CLOTRIMAZOLE Kobayashi Healthcare International, Inc. 1f1b413f-278e-434f-8590-4cf731663f5c 2026-05-15 Warnings Name fallback generic name: CLOTRIMAZOLE Tagrid Feminine Itch Relief Cream Antifungal Formula Clotrimazole 1% CLOTRIMAZOLE TAGRID LLC fe76e89c-470c-4903-bc8d-3fcdaee47d5a 2026-05-15 Warnings Name fallback generic name: CLOTRIMAZOLE Tagrid Intertrigo Cream For Skin Fold Rash Clotrimazole 1% CLOTRIMAZOLE TAGRID LLC d40453ba-cbd4-4087-98af-3ac721a55ab4 2026-05-15 Warnings Name fallback generic name: CLOTRIMAZOLE 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