Nail Antifungal Treatment

Product NDC
85283-001
11-digit product format
852830001
Labeler code
85283
Product ID
85283-001_4a9c8198-0dec-8302-e063-6394a90afcb3
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate 1% FUNGI NAIL
Dosage form
LIQUID
Route
TOPICAL
Labeler
BENM INC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-21
Substance
SALICYLIC ACID; TOLNAFTATE
Active strength
5; 1 mg/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nail Antifungal Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID5 mg/100mL
TOLNAFTATE1 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ, 06KB629TKV

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85283-001-01Nail Antifungal Treatment30 mL in 1 BOTTLELIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85283-001NAIL ANTIFUNGAL TREATMENT (TOLNAFTATE 1% FUNGI NAIL) LIQUID [BENM INC]1Current NDC, 1 package rows20250223_2ea24785-c648-4104-e063-6294a90ab12f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85283-001-018528300010130 mL in 1 BOTTLE (85283-001-01) 30 ml2025-02-21NoNoHistorical