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

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 Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui313423

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

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, GLASS2023-04-06NoNoHistorical
84728-510-02847280510022 BOTTLE, GLASS in 1 BOX (84728-510-02) / 15 mL in 1 BOTTLE, GLASS2025-01-31NoNoHistorical
84728-510-03847280510033 BOTTLE, GLASS in 1 BOX (84728-510-03) / 15 mL in 1 BOTTLE, GLASS2025-02-03NoNoHistorical