FDA.reportPublic FDA data

Dermatool Fungal Nail Treatment

Product NDC
84728-510
11-digit product format
847280510
Labeler code
84728
Product ID
84728-510_2d2c0e12-123e-75bd-e063-6394a90ae546
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate 1%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Papalo Group LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-06
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
Dermatool Fungal Nail Treatment
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
2d2c0e12-123d-75bd-e063-6394a90ae546Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84728-510-01Dermatool Fungal Nail Treatment1 in 1 CARTONLIQUID11
84728-510-01Dermatool Fungal Nail Treatment15 mL in 1 BOTTLE, GLASSLIQUID151
84728-510-02Dermatool Fungal Nail Treatment2 in 1 BOXLIQUID21
84728-510-02Dermatool Fungal Nail Treatment15 mL in 1 BOTTLE, GLASSLIQUID151
84728-510-03Dermatool Fungal Nail Treatment15 mL in 1 BOTTLE, GLASSLIQUID151
84728-510-03Dermatool Fungal Nail Treatment3 in 1 BOXLIQUID31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84728-510DERMATOOL FUNGAL NAIL TREATMENT (TOLNAFTATE 1%) LIQUID [PAPALO GROUP LLC]1Current NDC, 6 package rows20250204_2d2c0e12-123d-75bd-e063-6394a90ae546.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 33 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUNGAL NAILS REPAIRING ESSENCEPEPPERMINT OILZhenping Renren Industry Co., Ltd.3e82649c-d784-d64c-e063-6294a90ac95d2025-09-11WarningsExact identifier
application number: M005
equate Athletes FootTOLNAFTATEWal-Mart Stores Ince90297d0-0f87-4ae3-b9b7-959266d57c242025-09-11WarningsExact identifier
application number: M005
Bee Venom Toenail Fungus TreatmentBEE VENOM TOENAIL FUNGUS TREATMENTShenzhen Earth Surface Trading Co., Ltd.3e7d22b0-2f57-fcac-e063-6394a90aefd92025-09-10WarningsExact identifier
application number: M005
Amerfresh Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltdcdc4f0ff-07bd-47c8-850b-1698308bb6602025-09-09WarningsExact identifier
application number: M005
Antifungal CreamMICONAZOLE NITRATEEncube Ethicals, Inc.8be4bbfa-424c-4ccf-b8bc-65b16c1260532025-09-04WarningsExact identifier
application number: M005
ANTIFUNGALCLOTRIMAZOLEEncube Ethicals, Inc.afbc28f8-bb76-424d-9d73-136e6c283ead2025-09-04WarningsExact identifier
application number: M005
Hermon Balanitis relief kitSULFUR 1X HPUSBeautivity LLC3dce086e-a4eb-4b21-e063-6394a90aa1b22025-09-02WarningsExact identifier
application number: M005
Extra Strength Nail Fungus TreatmentUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abc0892-e52b-a40f-e063-6294a90a0e352025-09-02WarningsExact identifier
application number: M005
Hermon Balanitis CreamSULFUR 1X HPUSBeautivity LLC3dba4e4b-8224-6a96-e063-6394a90a91292025-09-01WarningsExact identifier
application number: M005
CaseysBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.a29d6c19-01aa-45b0-92cd-3f1148bad4f82025-08-30WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREEVALU MERCHANDISERS, CO.1d258684-9034-460c-953d-78e2b51981672025-08-26WarningsExact identifier
application number: M005
Femmesil Maximum StrengthMICONAZOLE NITRATEAidance Skincare & Topical Solutions, LLCd8b01fe1-4465-497b-909e-f51f31fdf8332025-08-25WarningsExact identifier
application number: M005
femmesil Ultra TherapyCLOTRIMAZOLEAidance Scientific, Inc.3d36794a-07d0-860c-e063-6294a90a6e8f2025-08-25WarningsExact identifier
application number: M005
Nedtol Folliculitis Treatment CreamsMICONAZOLE NITRATEJiashen International Trade Limited3d0a1e39-82e4-9337-e063-6294a90aa9a32025-08-23WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLETRIFECTA PHARMACEUTICALS USA LLC6b74d405-42d6-4c46-ba78-3007d1e8ffb82025-08-23WarningsExact identifier
application number: M005
FUNGLARA Anti FungalUNDECYLENIC ACIDFUNGLARA LLCa23c2399-36ea-4f22-8140-066e22c9a8622025-08-20WarningsExact identifier
application number: M005
Rapid MicroGelTOLNAFTATEThe Tetra Corporationafb6d7c4-1f75-4694-83c8-d6469250d6a12025-08-19WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEAvPAK3ca3b475-7b69-442a-e063-6294a90a7b3f2025-08-18WarningsExact identifier
application number: M005
Formula 3TOLNAFTATEThe Tetra Corporation0895274b-a09d-4264-a43f-852e44eb31632025-08-18WarningsExact identifier
application number: M005
Formula 7 - The SolutionTOLNAFTATEThe Tetra Corporation18619649-7f79-4b6e-8b7c-69d70365d5572025-08-18WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSN2d2c0e12-123d-75bd-e063-6394a90ae5461
313423tolnaftate 10 MG/ML Topical SolutionSCD2d2c0e12-123d-75bd-e063-6394a90ae5461
313423tolnaftate 1 % Topical SolutionSY2d2c0e12-123d-75bd-e063-6394a90ae5461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84728-510-01847280510011 BOTTLE, GLASS in 1 CARTON (84728-510-01) / 15 mL in 1 BOTTLE, GLASS2023-04-06NoNoCurrent
84728-510-02847280510022 BOTTLE, GLASS in 1 BOX (84728-510-02) / 15 mL in 1 BOTTLE, GLASS2025-01-31NoNoCurrent
84728-510-03847280510033 BOTTLE, GLASS in 1 BOX (84728-510-03) / 15 mL in 1 BOTTLE, GLASS2025-02-03NoNoCurrent