Secura Antifungal

Product NDC
69740-328
11-digit product format
697400328
Labeler code
69740
Product ID
69740-328_4e7a7f19-4af6-d825-e063-6394a90aa2d4
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Smith & Nephew Medical Ltd
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-08-01
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct69740-328IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69740-32869740-328-00IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
Secura Antifungal
Brand name suffix
Greaseless
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998483Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9be600e4-76ec-4071-a8ec-a0b23155271dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69740-328-002024-03-12C16284748780-11030e365-1b60-111a-e063-dadaa90a10e2Secura Antifungal
69740-328-002024-01-30C16284748780-11030e365-1b60-111a-e063-dadaa90a10e2Secura Antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69740-328-00Secura AntifungalGreaseless57 g in 1 TUBECREAM5713

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
MICONAZOLEACTIVE MOIETY7NNO0D7S5MSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
ALLANTOININACTIVE INGREDIENT344S277G0ZSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744SECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8SECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
CETETH-20INACTIVE INGREDIENTI835H2IHHXSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4SECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309SECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
KARAYA GUMINACTIVE INGREDIENT73W9IQY50QSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
POLYOXYL 40 CASTOR OILINACTIVE INGREDIENT4ERD2076EFSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
SODIUM CETOSTEARYL SULFATEINACTIVE INGREDIENT7ZBS06BH4BSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
WATERINACTIVE INGREDIENT059QF0KO0RSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69740-328SECURA ANTIFUNGAL GREASELESS (MICONAZOLE NITRATE) CREAM SECURA ANTIFUNGAL EXTRA THICK (MICONAZOLE NITRATE) CREAM [SMITH & NEPHEW MEDICAL LTD]12Current NDC, Legacy NDC, 1 package rows20250418_9be600e4-76ec-4071-a8ec-a0b23155271d.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 6 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c93390-ee07-4f78-e063-6394a90add422026-07-17WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kitPSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56cb7085-87d8-4273-e063-6394a90ac5df2026-07-17WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT CARETOLNAFTATE 1% ANTIFUNGAL FOOT CAREWenzhou Yuyuan Pharmaceutical Co., Ltd.56b10492-894c-33e1-e063-6394a90a8c0f2026-07-17WarningsExact identifier
application number: M005
Foot Choice-Nail Fungal PenUNDECYLENIC ACIDFoot Choice LLC4b0036a6-8751-4f44-b6b1-5be57fa92cdc2026-07-17WarningsExact identifier
application number: M005
2% MICONAZOLE NITRATE ANTIFUNGAL Cream2% MICONAZOLE NITRATE ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd56b54359-db21-b8b4-e063-6394a90a6f8c2026-07-16WarningsExact identifier
application number: M005
DRAVYNOR BALANITIS RELIEF CreamMICONAZOLE NITRATE 2% BALANITIS RELIEF CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.56b76a52-0743-4fe6-e063-6294a90a98a82026-07-16WarningsExact identifier
application number: M005
5% Benzoyl Peroxide FOLLICULITIS Cream5% BENZOYL PEROXIDE FOLLICULITIS CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd56c558fa-303f-fc52-e063-6394a90a72f02026-07-16WarningsExact identifier
application number: M005
Antifungal Ringworm Treatment CreamMICONAZOLE NITRATEYunqi Cosmetics (Shenzhen) Co., Ltd56a2ceea-c4c0-c30c-e063-6394a90a0e6a2026-07-15WarningsExact identifier
application number: M005
Medi-First Antifungal Cream Miconazole CreamMICONAZOLEUnifirst First Aid Corporation56a51b75-9c23-bcd2-e063-6394a90a9b122026-07-15WarningsExact identifier
application number: M005
Clear Root Labs Tinea TreatmentCLEAR ROOT LABS TINEA TREATMENTAidance Scientic Inc., DBA Aidance Skincare & Topicals56a67bad-c677-d3b7-e063-6394a90ad2052026-07-15WarningsExact identifier
application number: M005
Clear Root Labs Antifungal TreatmentCLEAR ROOT LABS ANTIFUNGAL TREATMENTAidance Scientific, Inc., DBA Aidance Skincare & Topicals5696bf23-230a-5f37-e063-6294a90a74132026-07-15WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL NAIL LiquidTOLNAFTATE 1% ANTIFUNGAL NAIL LIQUIDJiangxi Yudexi Pharmaceutical Co., LTD56b17e50-bff1-5eb0-e063-6294a90a3c082026-07-15WarningsExact identifier
application number: M005
terrasil Antifungal Cleansing BarCLOTRIMAZOLEAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions10a4fde0-87e1-4474-bcb5-255b0a7f1ecb2026-07-14WarningsExact identifier
application number: M005
OAKDOLCHE Tea Tree Oil AntifungalTOLNAFTATENanjing Qiaotun Technology Co., Ltd.569dee15-e68d-220e-e063-6294a90af7c52026-07-14WarningsExact identifier
application number: M005
Kimtara Nail Fungus TreatmentKIMTARA NAIL FUNGUS TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5678e260-10c4-f203-e063-6294a90a62232026-07-13WarningsExact identifier
application number: M005
Aiilo NAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.5689ac31-4d23-0fcc-e063-6394a90ac75b2026-07-13Exact identifier
application number: M005
MIWIFY ANTIFUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.56519b25-f3c8-bcac-e063-6394a90af8792026-07-11WarningsExact identifier
application number: M005
Joymeey FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5652a22e-7b43-3c31-e063-6294a90ae4f12026-07-11WarningsExact identifier
application number: M005
iBeaLee Nail Repair PenIBEALEE NAIL REPAIR PENShenzhen Earth Surface Trading Co., Ltd.564dc711-7fe2-7a8d-e063-6294a90aac262026-07-10WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN9be600e4-76ec-4071-a8ec-a0b23155271d13
998483miconazole nitrate 20 MG/ML Topical CreamSCD9be600e4-76ec-4071-a8ec-a0b23155271d13
998483miconazole nitrate 2 % Topical CreamSY9be600e4-76ec-4071-a8ec-a0b23155271d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69740-328-006974003280057 g in 1 TUBE (69740-328-00) 57 g2003-08-010000-00-00NoNoCurrent