FDA.reportPublic FDA data

Silka Antifungal

Product NDC
50066-085
11-digit product format
500660085
Labeler code
50066
Product ID
50066-085_9c9b657b-df37-4ee7-acd4-0f2ba98a891f
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
LIQUID
Route
TOPICAL
Labeler
Genomma Lab USA
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-30
Substance
TOLNAFTATE
Active strength
1 g/100mL
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 Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313423Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb1dc636-837f-491c-97c1-e74288aebc27Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-085-01Silka Antifungal13 mL in 1 BOTTLE, GLASSLIQUID131
50066-085-01Silka Antifungal1 in 1 CARTONLIQUID11

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 48 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Black Bottle Tea Tree Antifungal Foot and Body WashTOLNAFTATERestoration Rockstar, Llc (dba: Kroning Signature Black Bottle)2c966d97-30f5-4942-b64d-742884ce6a2f2023-11-10WarningsExact identifier
application number: M005
Smooth Gator Fungus EliminatorCLOTRIMAZOLESmooth Gator, LLC262b04f5-1b5d-4c67-a557-01f8b17113022023-11-10WarningsExact identifier
application number: M005
TOLNAFTATE ANTIFUNGALTOLNAFTATEGeri-Care Pharmaceuticals, Corpf9e60430-eec1-4bc2-9522-eb5aa527d90a2023-11-08WarningsExact identifier
application number: M005
Terrasil Jock Itch Treatment Maximum StrengthCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCc62fbf23-5d19-44ab-9c1a-e9b803192ed02023-11-08WarningsExact identifier
application number: M005
terrasil The Fungal Solution KitCLOTRIMAZOLEAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions9a5eb581-62a2-41fe-a174-e852fc47e2352023-11-08WarningsExact identifier
application number: M005
EmoniNail AntifungalUNDECYLENIC ACIDGG Healthworks Inc.84ace47a-d3ae-4735-87b6-dbbf1c40cf542023-11-06WarningsExact identifier
application number: M005
CIDACIN Antifungal TreatmentTOLNAFTATEPedicis Research LLCbd53a9e3-65c8-4834-8e23-a2a928b83a662023-11-05WarningsExact identifier
application number: M005
MacerRx WebMICONAZOLE NITRATEClinical Therapeutic Solutionsc9327f41-10f1-41f3-855b-838c701d67672023-11-05WarningsExact identifier
application number: M005
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions7e8897ff-67d1-4336-866e-cb76a36edddc2023-11-05WarningsExact identifier
application number: M005
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions308a91d1-3511-4e2d-a62f-a31d77d70e062023-11-05WarningsExact identifier
application number: M005
Human Science Antifungal Foot CareUNDECYLENIC ACIDHUMAN SCIENCE, LLC26b2519b-7d7b-4b33-b5d6-a41fe6f735382023-11-05WarningsExact identifier
application number: M005
HomeHealth AntifungalTOLNAFTATEHome Health895cd24c-3f78-4e2e-bf98-8bb6605798da2023-11-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LP800a9dab-d287-427e-af6d-26996e0def412023-11-01WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE-IODINEDr Radows58e1757c-45ce-455e-bd64-a9e99cd3680f2023-10-30WarningsExact identifier
application number: M005
JOCK-EZECLOTRIMAZOLEBentlin Products LLCd3ff5bfb-2e0f-4daa-84b3-4a3016ca92802023-10-30WarningsExact identifier
application number: M005
TheraPlus PlusCLOTRIMAZOLEZhejiang Jingwei Pharmaceutical Co., Ltd.de75179d-1889-4823-9f39-4bebdf185d762023-10-27WarningsExact identifier
application number: M005
Evercare Antifungal Treatment Super Absorbent PowderMICONAZOLE NITRATEPANEFFORT, LLCf91910f3-b461-43a4-9120-fda69483fffa2023-10-26WarningsExact identifier
application number: M005
Thera plus Antifungal ClotrimazoleCLOTRIMAZOLEFOURSTAR GROUP USA, INC.1265be99-8922-4b76-bd63-19bfb42c38962023-10-26WarningsExact identifier
application number: M005
Thera plus Antifungal TolnaftateTOLNAFTATEFOURSTAR GROUP USA, INC.c628dda8-7a6d-5f3a-e053-2995a90a35f82023-10-26WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltde1789944-3a41-4c86-b173-3a6993ae21412023-10-23WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSNfb1dc636-837f-491c-97c1-e74288aebc271
313423tolnaftate 10 MG/ML Topical SolutionSCDfb1dc636-837f-491c-97c1-e74288aebc271
313423tolnaftate 1 % Topical SolutionSYfb1dc636-837f-491c-97c1-e74288aebc271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50066-085-01500660085011 BOTTLE, GLASS in 1 CARTON (50066-085-01) / 13 mL in 1 BOTTLE, GLASS2025-09-30NoNoCurrent