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 47 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ER Hand Sanitizer PacketsALCOHOLEVER READY FIRST AIDd0b6d09c-26e0-45c7-8d37-7d42143b2e312024-01-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEProficient Rx LPeeb241a3-93ee-4b74-8cbb-65713d15e7e02024-01-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LPba1dc4a4-073f-4f30-bb9c-9ed0437004312024-01-01WarningsExact identifier
application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEProficient Rx LP7c64553b-589c-4e65-a6f0-b2847bbbe8a62024-01-01WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes foot treatment with MentholTOLNAFTATEScholl's Wellness Companydad00745-e411-35b8-e053-2a95a90a10002023-12-21WarningsExact identifier
application number: M005
TINEACIDETOLNAFTATEBlaine Labs Inc.273eb424-5dc3-40c8-9ea7-2f732cbd11c92023-12-21WarningsExact identifier
application number: M005
TERPENICOL ANTIFUNGALUNDECYLENIC ACIDBlaine Labs Inc.a020334e-aac9-4ea5-a0ea-8e5b021fe2eb2023-12-21WarningsExact identifier
application number: M005
TERPENICOLUNDECYLENIC ACIDBlaine Labs Inc.efd99ed1-07d3-4862-ae47-883f7d1c91c62023-12-21WarningsExact identifier
application number: M005
sunmark antifungalTOLNAFTATEA-S Medication Solutions6f85fbb0-297c-4949-83f2-ed9a521721542023-12-16WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7a0ef38a-9584-4e67-ba86-c31f86da1ed02023-12-11WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7d284f6f-a970-49fe-b45a-d5c6c2688bc22023-12-11WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.2096e241-3ed3-49cd-88c4-71db1fd2934a2023-12-06WarningsExact identifier
application number: M005
Undecylenic AcidUNDECYLENIC ACIDChemco Corporation7391b53f-5567-1f45-e053-2991aa0a4fce2023-12-05WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.be92b480-56e8-4371-adbc-40fe74f6747c2023-12-01WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb4c4240f-f84c-ec5e-e053-2a95a90aa0822023-11-17WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb564f971-2a9b-a605-e053-2995a90aee692023-11-17WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLEVERLIT GLOBAL INC.b9909c59-02e7-4d6c-aa2b-206f1ab4d02c2023-11-14WarningsExact identifier
application number: M005
FLUSH Maximum Strength Antifungal formulaUNDECYLENIC ACIDTriple Point Group, LLC1d9e56ef-c7c9-4aff-ab9e-b163e566e3d52023-11-11WarningsExact identifier
application number: M005
SIMPLY VITAL Antifungal CreamCLOTRIMAZOLEALPHA PLANTS INCd3842de3-0d13-4dc2-920b-90a4b822bbb82023-11-11WarningsExact identifier
application number: M005
CLARUS AC Antifungal SolutionTOLNAFTATEClinical Therapeutic Solutions28ab9f1b-65cd-4405-a9a3-f3c9b836693d2023-11-10WarningsExact 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