DermaSana

Product NDC
55992-023
11-digit product format
559920023
Labeler code
55992
Product ID
55992-023_76022b1f-449d-418a-9065-47b565f9efa0
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
OMG Medical Group, LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-02-14
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE; TRICLOSAN
Active strength
200 mg/mg; mg/mg
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55992-023IInactivated by FDA2026-10-16
excluded packagepackage55992-02355992-023-01IInactivated by FDA2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55992-023-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55992-023-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55992-023-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55992-023-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55992-023-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55992-023-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55992-023-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55992-023-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55992-023-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55992-023-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55992-023-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55992-023-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55992-023-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55992-023-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55992-023-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55992-023-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55992-023-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55992-023-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55992-023-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55992-023-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55992-023-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55992-023-01110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55992-023-012019-11-27C16284748780-19855d018-d95e-cd31-e053-dbdaa90ab51aDermaSana

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55992-023-01DermaSana200 mg in 1 PACKAGECREAM2006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
TRICLOSANACTIVE INGREDIENT4NM5039Y5XDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
MICONAZOLEACTIVE MOIETY7NNO0D7S5MDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
TRICLOSANACTIVE MOIETY4NM5039Y5XDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70DERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
LAURETH-7INACTIVE INGREDIENTZ95S6G8201DERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
POLYACRYLAMIDE (10000 MW)INACTIVE INGREDIENTE2KR9C9V2IDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6
WATERINACTIVE INGREDIENT059QF0KO0RDERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55992-023DERMASANA (MICONAZOLE NITRATE) CREAM [OMG MEDICAL GROUP, LLC]6Legacy NDC, 1 package rows20130325_f3e0eb4c-3b09-4d1c-9067-c58b8e06c50f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55992-023-0155992002301200 mg in 1 PACKAGE200 mgHistorical