FDA.reportPublic FDA data

Silka Athletes Foot

Product NDC
50066-084
11-digit product format
500660084
Labeler code
50066
Product ID
50066-084_c55dd887-1f9e-4ffc-a6a7-2ca1fa7d5407
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Genomma Lab USA
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-03
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Silka Athletes Foot
Listing expiration
2026-12-31

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
998428Internal RxNorm lookup
2704865Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
307104a2-2df6-43b0-bf3f-f4d93d3e40f1Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-084-46Silka Athletes Foot130 g in 1 CANISTERAEROSOL, SPRAY1301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-084SILKA ATHLETES FOOT (MICONAZOLE NITRATE) AEROSOL, SPRAY [GENOMMA LAB USA]1Current NDC, 1 package rows20250209_307104a2-2df6-43b0-bf3f-f4d93d3e40f1.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 38 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd67d1d65a-71d4-41fc-a71c-85a28ce6de0c2025-06-18WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd640df217-6982-441e-835a-dbe2031e732b2025-06-18WarningsExact identifier
application number: M005
EYELID WIPESEYELID WIPESShenzhen Shierjie Biological Engineering Co., LTD377fb842-aa78-ab2a-e063-6394a90a69f92025-06-13WarningsExact identifier
application number: M005
Lunavia Antifungal Foot BalmZINC UNDECYLENATE 10%XF Agencija Limited466f3285-9800-4219-902f-b78a713b952f2025-06-13WarningsExact identifier
application number: M005
Foot Cure Antifungal Foot BalmZINC UNDECYLENATESansar LLCac6075bf-cc1d-4e8a-aa13-5a85e80f34ee2025-06-13WarningsExact identifier
application number: M005
Lunavia AntifungalUNDECYLENIC ACID 25%XF Agencija Limited55891d2f-e2b8-4d9f-8140-dc258926ed902025-06-13WarningsExact identifier
application number: M005
TEGASOLVE TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Zhengzhou Hangrui Network Technology Co., Ltd.375b0515-1b1f-23b8-e063-6294a90a9d682025-06-12WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREECVS Pharmacy979ab1d2-f184-455d-b31a-2ff2bd4592b82025-06-12WarningsExact identifier
application number: M005
Gemachlich ZuHause Fungal Nail RevitalizerGEMACHLICH ZUHAUSE FUNGAL NAIL REVITALIZERGuangdong Quadrant Ecological Technology Co., Ltd.37332cdf-7171-42cc-e063-6394a90a0fcf2025-06-10WarningsExact identifier
application number: M005
Eyelid WipesEYELID WIPESShenzhen Shierjie Biological Engineering Co., LTD36ddfa37-3913-9e48-e063-6294a90ae1be2025-06-08WarningsExact identifier
application number: M005
Everywhere Flushable WipesEVERYWHERE FLUSHABLE WIPESShenzhen Shierjie Biological Engineering Co., LTD371be299-5aaf-b9d7-e063-6294a90a87f52025-06-08WarningsExact identifier
application number: M005
Fungus MasterMICONAZOLE NITRATEClinical Resolution Laboratory, Inc.36eb334e-246b-249f-e063-6294a90ab8112025-06-06WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEHudson Health LLC8d725a50-fbe4-4a48-9cbf-f8b5c12dd6472025-06-03WarningsExact identifier
application number: M005
CharmTex Lightly Scented AntibacterialBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd1c9f4bff-3f6f-4498-b8a2-7d7f49d6ad2d2025-06-01WarningsExact identifier
application number: M005
DermaD ANTIFUNGAL TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.b97684ae-79d0-4208-b480-67794596ece72025-05-29WarningsExact identifier
application number: M005
Fungazol Athlete FootMICONAZOLE NITRATERida LLCce60e1ec-a69b-4b98-a2b2-105e9cd37bc72025-05-28WarningsExact identifier
application number: M005
Antifungal Boday WashTOLNAFTATECAVTECH HOLDING LLC3619d717-fe42-412f-e063-6394a90a03842025-05-27WarningsExact identifier
application number: M005
Toenail Fungus LiquidTOENAIL FUNGUS LIQUIDShenzhen Earth Surface Trading Co., Ltd.361f4c5c-7fa7-0440-e063-6294a90aad9f2025-05-27WarningsExact identifier
application number: M005
help it AntisepticBENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b22f423-eb11-445f-a484-9326c1fe3ad52025-05-27WarningsExact identifier
application number: M005
Seacall Hydrocortisone Ointment.SEACALL HYDROCORTISONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.3616980a-03dc-deba-e063-6394a90a6ce72025-05-26WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998428miconazole nitrate 2 % Powder SprayPSN307104a2-2df6-43b0-bf3f-f4d93d3e40f11
2704865SILKA 2 % Powder SprayPSN307104a2-2df6-43b0-bf3f-f4d93d3e40f11
2704865miconazole nitrate 0.02 MG/MG Powder Spray [Silka Powder]SBD307104a2-2df6-43b0-bf3f-f4d93d3e40f11
998428miconazole nitrate 0.02 MG/MG Powder SpraySCD307104a2-2df6-43b0-bf3f-f4d93d3e40f11
998428miconazole nitrate 2 % Powder SpraySY307104a2-2df6-43b0-bf3f-f4d93d3e40f11
2704865Silka Powder 0.02 MG/MG Powder SpraySY307104a2-2df6-43b0-bf3f-f4d93d3e40f11
2704865Silka Powder 2 % Powder SpraySY307104a2-2df6-43b0-bf3f-f4d93d3e40f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50066-084-4650066008446130 g in 1 CANISTER (50066-084-46) 130 g2025-02-03NoNoCurrent