Home NDC 69396-130 Tolnaftate
Product NDC 69396-130
11-digit product format 693960130
Labeler code 69396
Product ID 69396-130_2a923ecc-8dad-73b1-e063-6394a90a7022
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate 1%
Dosage form CREAM
Route TOPICAL
Labeler Trifecta Pharmaceuticals USA, LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-30
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
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 69396-130-01 Tolnaftate 1 in 1 BOX CREAM 1 2 69396-130-01 Tolnaftate 28.3 g in 1 TUBE CREAM 28.3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-130 TOLNAFTATE (TOLNAFTATE 1%) CREAM [TRIFECTA PHARMACEUTICALS USA, LLC] 2 Current NDC, 2 package rows 20250101_091b907f-544a-86c9-e063-6294a90a5d87.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 8 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 69396-130-01 69396013001 1 TUBE in 1 BOX (69396-130-01) / 28.3 g in 1 TUBE 1 tube 2023-06-30 No No Current