Home NDC 85565-008 Dryello Tolnaftate 1% Antifungal
Product NDC 85565-008
11-digit product format 855650008
Labeler code 85565
Product ID 85565-008_58b6820c-f602-5921-e063-6294a90aa5e9
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form STICK
Route TOPICAL
Labeler ProPedix, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-10
Substance TOLNAFTATE
Active strength 1 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 Dryello Tolnaftate 1% Antifungal
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 06KB629TKV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199126 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 23 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85565-008-01 85565000801 2 APPLICATOR in 1 BOX (85565-008-01) / 15 g in 1 APPLICATOR 2 applicator 2026-08-10 No No Current