Home NDC 85477-331 Tolfyra
Product NDC 85477-331
11-digit product format 854770331
Labeler code 85477
Product ID 85477-331_9a2daff0-df69-4dd4-9b2b-84d1b74de374
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form LIQUID
Route TOPICAL
Labeler Oncora Pharma, LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-01
Substance TOLNAFTATE
Active strength .3 g/30mL
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 Tolfyra
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE .3 g/30mL
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 313423 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85477-331-01 Tolfyra 30 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 30 6
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 36 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85477-331-01 85477033101 30 mL in 1 BOTTLE, WITH APPLICATOR (85477-331-01) 30 ml 2026-05-01 No No Current