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 34 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlyCylicSALICYLIC ACIDThe Tetra Corporation501d3ba9-ba42-4c1c-983b-492adaee039d2025-08-18WarningsExact identifier
application number: M005
SupreH Ringworm Treatment BalmSUPREH RINGWORM TREATMENT BALMShenzhen Xinxin Yunhai Technology Co., Ltd.3c77222b-d92e-84b0-e063-6294a90aadd72025-08-16WarningsExact identifier
application number: M005
OetMoe Antifungal SolutionOETMOE ANTIFUNGAL SOLUTIONShenzhen Earth Surface Trading Co., Ltd.3c26d917-4186-6f02-e063-6394a90a99f62025-08-12WarningsExact identifier
application number: M005
Cureforte Anti Fungal Foot CareANTI FUNGAL FOOT CARE DROPSSTEEL CITY HEALTH PRIVATE LIMITED39f762a6-9d0c-8ded-e063-6394a90a36592025-08-11WarningsExact identifier
application number: M005
Derman Antifungal Powder TolnaftateTOLNAFTATETaisho Pharmaceutical California Inc.3a854765-740c-4719-8abf-4b3f932cdee02025-08-07WarningsExact identifier
application number: M005
Derman antifungal creamTOLNAFTATETaisho Pharmaceutical California Inc.15d9b3c9-01af-4083-a1bc-014505d8798d2025-08-07WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEHudson Health LLC24b22794-f9f8-6f32-e063-6394a90aec982025-08-07WarningsExact identifier
application number: M005
Toe Area TreatmentTOLNAFTATECVS17681cc8-fbb1-a0cf-e063-6294a90add182025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc178e7b3f-949f-3f51-e063-6294a90a93952025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATELEADER/Cardinal Health 110, Inc.17695563-3765-74cb-e063-6294a90a61202025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETarget Corporation1dff278f-47bc-459a-e063-6394a90a26462025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETopCo Associates19c268a1-7b2e-63c9-e063-6394a90acddc2025-08-07WarningsExact identifier
application number: M005
Antifungal Liquid Maximum StrengthTOLNAFTATEWalgreens Company137eabb7-cb4f-1631-e063-6294a90ab8472025-08-07WarningsExact identifier
application number: M005
WCTNGO Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad0d73-b33d-b962-e063-6294a90a7ba72025-08-06WarningsExact identifier
application number: M005
ONIADBA Nail Fungus Treatment PenTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad19f1-d5b3-c5de-e063-6294a90a0c032025-08-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEPremier Brands of America Inc2644ba07-aaee-6402-e063-6394a90a28272025-08-06WarningsExact identifier
application number: M005
Anti- Fungal Miconazole NitrateMICONAZOLE NITRATEPremier Brands of America Inc.f186bdc1-db6c-0fab-e053-2995a90a7c582025-08-06WarningsExact identifier
application number: M005
ONIADBA Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3baa99ab-6d22-8d7d-e063-6294a90af3e82025-08-05WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.cca84334-2e2d-4991-9d1e-d5b7c9ffd3922025-08-01WarningsExact identifier
application number: M005
RoyceDerm CoolDefense Refreshing Shower GelTOLNAFTATE 1.0%RoyceDerm LLC3b3216d6-8cc8-ea89-e063-6294a90ab6912025-07-31WarningsExact 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