Home NDC 55319-538 Antifungal Liquid
Product NDC 55319-538
11-digit product format 553190538
Labeler code 55319
Product ID 55319-538_3bcee78b-434d-e14d-e063-6394a90a6444
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form LIQUID
Route TOPICAL
Labeler Family Dollar Services, Inc
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-03
Marketing end 2026-11-30
Substance TOLNAFTATE
Active strength 10 mg/mL
NDC exclude flag No
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 Antifungal Liquid Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 10 mg/mL
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 55319-538-01 Antifungal Liquid 1 in 1 CARTON LIQUID 1 3 55319-538-01 Antifungal Liquid 30 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-538 ANTIFUNGAL LIQUID (TOLNAFTATE) LIQUID [FAMILY DOLLAR SERVICES, INC] 2 Current NDC, 2 package rows 20241123_178e7b3f-949f-3f51-e063-6294a90a9395.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 23 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55319-538-01 55319053801 1 BOTTLE, WITH APPLICATOR in 1 CARTON (55319-538-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR 2024-05-03 2026-11-30 No No Historical