Home NDC 69396-042 Tolnaftate Cream 1% ANTIFUNGAL
Product NDC 69396-042
11-digit product format 693960042
Labeler code 69396
Product ID 69396-042_29b3b3a6-1e40-3efa-e063-6294a90a15c2
Type HUMAN OTC DRUG
Nonproprietary name Family Wellness Tolnaftate
Dosage form CREAM
Route TOPICAL
Labeler Trifecta Pharmaceuticals USA, LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-30
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 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 69396-042-05 Tolnaftate Cream 1% ANTIFUNGAL 1 in 1 BOX CREAM 1 5 69396-042-05 Tolnaftate Cream 1% ANTIFUNGAL 15 g in 1 TUBE CREAM 15 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-042 TOLNAFTATE CREAM 1% ANTIFUNGAL (FAMILY WELLNESS TOLNAFTATE) CREAM [TRIFECTA PHARMACEUTICALS USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241222_915759af-0d7f-6a87-e053-2a95a90acbd6.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 51 · 1,004 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 69396-042-05 69396004205 1 TUBE in 1 BOX (69396-042-05) / 15 g in 1 TUBE 1 tube 2019-08-30 0000-00-00 No No Current