Home NDC 69396-016 Tolnaftate Cream 1% ANTIFUNGAL
Product NDC 69396-016
11-digit product format 693960016
Labeler code 69396
Product ID 69396-016_352f8de3-8ff3-4098-e063-6294a90ace4d
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form CREAM
Route TOPICAL
Labeler Trifecta Pharmaceuticals Usa Llc
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-04-09
Substance TOLNAFTATE
Active strength 1 g/100g
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 Tolnaftate Cream 1% ANTIFUNGAL
Listing expiration 2026-12-31 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 103951 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 69396-016-05 Tolnaftate Cream 1% ANTIFUNGAL 1 in 1 BOX CREAM 1 8 69396-016-05 Tolnaftate Cream 1% ANTIFUNGAL 15 g in 1 TUBE CREAM 15 8 69396-016-20 Tolnaftate Cream 1% ANTIFUNGAL 1 in 1 BOX CREAM 1 8 69396-016-20 Tolnaftate Cream 1% ANTIFUNGAL 30 g in 1 TUBE CREAM 30 8 69396-016-33 Tolnaftate Cream 1% ANTIFUNGAL 30 g in 1 TUBE CREAM 30 8 69396-016-33 Tolnaftate Cream 1% ANTIFUNGAL 3 in 1 BOX CREAM 3 8 69396-016-66 Tolnaftate Cream 1% ANTIFUNGAL 30 g in 1 TUBE CREAM 30 8 69396-016-66 Tolnaftate Cream 1% ANTIFUNGAL 6 in 1 BOX CREAM 6 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-016 TOLNAFTATE CREAM 1% ANTIFUNGAL (TOLNAFTATE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC] 8 Current NDC, Legacy NDC, 8 package rows 20250516_96a40ccd-17f7-4e4e-98da-207802fa2b2d.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 40 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 Marketing end Sample Exclude flag Status 69396-016-05 69396001605 1 TUBE in 1 BOX (69396-016-05) / 15 g in 1 TUBE 1 tube 2016-04-09 0000-00-00 No No Current 69396-016-20 69396001620 1 TUBE in 1 BOX (69396-016-20) / 30 g in 1 TUBE 1 tube 2016-04-09 0000-00-00 No No Current 69396-016-33 69396001633 3 TUBE in 1 BOX (69396-016-33) / 30 g in 1 TUBE 3 tube 2025-05-15 No No Current 69396-016-66 69396001666 6 TUBE in 1 BOX (69396-016-66) / 30 g in 1 TUBE 6 tube 2023-06-20 No No Current