FDA.reportPublic FDA data

Desenex

Product NDC
0316-0225
11-digit product format
003160225
Labeler code
0316
Product ID
0316-0225_4833f384-eb1d-0049-e063-6394a90a9f53
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
POWDER
Route
TOPICAL
Labeler
Crown Laboratories
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-19
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0316-0225DDiscontinued by firm2026-09-14
excluded packagepackage0316-02250316-0225-15DDiscontinued by firm2026-09-14
excluded packagepackage0316-02250316-0225-30DDiscontinued by firm2026-09-14

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 · 6 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 packagepackage0316-0225-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0316-0225-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0316-0225-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0316-0225-15f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Desenex
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998461Internal RxNorm lookup
998465Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
09964187-12f1-bbe6-e063-6394a90acba0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0225-01Desenex43 g in 1 BOTTLE, PLASTICPOWDER434
0316-0225-02Desenex85 g in 1 BOTTLE, PLASTICPOWDER854

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0225-15GM - Gram0316-022501400da0-bdbd-4a2e-9de5-d2848d3a99ef12019-01-24
0316-0225-30GM - Gram0316-022541ddbc5d-8568-478a-a3a1-fdee93d77f5412019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0225DESENEX (MICONAZOLE NITRATE) POWDER [CROWN LABORATORIES]10Current NDC, Legacy NDC20231216_7c4a483e-199a-7ee1-e053-2a91aa0a3dec.zip
0316-0225DESENEX (MICONAZOLE NITRATE) POWDER [CROWN LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20231111_09964187-12f1-bbe6-e063-6394a90acba0.zip

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 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Antifungal Medicated BarTOLNAFTATEDefense Soap LLC812d78ea-a14a-e3a2-e053-2a91aa0a6ff52026-09-09WarningsExact identifier
application number: M005
Radthary GROIN ANTIFUNGAL CreamMICONAZOLE NITRATE 2% GROIN ANTIFUNGAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5b1945f3-84ba-f3dc-e063-6294a90ab8a02026-09-09WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsExact identifier
application number: M005
Remedy Antifungal With OlivamineMICONAZOLE NITRATEMedline Industries, LP28c5183e-05b4-1754-e054-00144ff8d46c2026-09-08WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATE 2%Gentell LLC5afdc429-cb44-703c-e063-6294a90a971a2026-09-08WarningsExact identifier
application number: M005
HSENJT Antifungal CreamMICONAZOLE NITRATEHuizhou Haosen Trading Co., Ltd.5aa587f5-5ddf-542a-e063-6294a90a522b2026-09-07WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALMICONAZOLE NITRATE 2% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4a832f39-ac11-d8b3-e063-6394a90acb392026-09-06WarningsExact identifier
application number: M005
Noicaky FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5adcc5f7-2d47-2ad7-e063-6294a90a48482026-09-06WarningsExact identifier
application number: M005
LIFE66II ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab83796-0780-3b58-e063-6394a90a2e4e2026-09-05WarningsExact identifier
application number: M005
FGPER Topical Antifungal PenUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5abdcbff-6ab1-2f0a-e063-6294a90a57ef2026-09-05WarningsExact identifier
application number: M005
AOUGK SALICYLIC ACID WART REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5ac88b51-b46c-5cc6-e063-6394a90af9e52026-09-05WarningsExact identifier
application number: M005
Jock Itch PowderMICONAZOLE NITRATEPremier Brands of America Inc5aaacc88-6752-ab47-e063-6394a90af7cd2026-09-04WarningsExact identifier
application number: M005
ANTIFUNGAL BODY WASHTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.5a695043-f776-df5a-e063-6394a90ac2742026-09-01WarningsExact identifier
application number: M005
KetoconClear CreamKETOCONAZOLEGuangzhou Shunfei Network Technology Co., Ltd.5a54eebe-5b4a-28dd-e063-6294a90a607f2026-08-31WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEInvaDerm Corporation5a5cfed9-0587-7bef-e063-6294a90a64bf2026-08-31WarningsExact identifier
application number: M005
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-27WarningsExact identifier
application number: M005
DrAny NAIL FUNGUS TREATMENTUNDECYLENIC ACID, TOLNAFTATEHong Kong Juxin Negosyo Kag Komersyo Co., Limited59ef412b-fc7b-0a84-e063-6394a90abf252026-08-26WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
application number: M005
Okkazhie WART REMOVER40% SALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.59c2d759-d1e9-6c9d-e063-6294a90a04db2026-08-23WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998465Desenex 2 % Topical PowderPSN09964187-12f1-bbe6-e063-6394a90acba04
998461miconazole nitrate 2 % Topical PowderPSN09964187-12f1-bbe6-e063-6394a90acba04
998465miconazole nitrate 0.02 MG/MG Topical Powder [Desenex]SBD09964187-12f1-bbe6-e063-6394a90acba04
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD09964187-12f1-bbe6-e063-6394a90acba04
998465Desenex 0.02 MG/MG Topical PowderSY09964187-12f1-bbe6-e063-6394a90acba04
998465Desenex 2 % Topical PowderSY09964187-12f1-bbe6-e063-6394a90acba04
998461miconazole nitrate 2 % Topical PowderSY09964187-12f1-bbe6-e063-6394a90acba04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0225-010031602250143 g in 1 BOTTLE, PLASTIC (0316-0225-01) 43 g2023-10-19NoNoCurrent
0316-0225-020031602250285 g in 1 BOTTLE, PLASTIC (0316-0225-02) 85 g2023-10-19NoNoCurrent
0316-0225-150031602251543 g in 1 CONTAINER (0316-0225-15) 43 g2018-12-010000-00-00NoNoCurrent
0316-0225-300031602253085 g in 1 CONTAINER (0316-0225-30) 85 g2018-12-010000-00-00NoNoCurrent