Home NDC 55505-193 Fungi Nail Anti-Fungal Pen
Product NDC 55505-193
11-digit product format 555050193
Labeler code 55505
Product ID 55505-193_c41f43f6-0f87-4dbb-89f2-6e0a36ac081b
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form LIQUID
Route TOPICAL
Labeler Kramer Laboratories
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-03-01
Substance TOLNAFTATE
Active strength 1 g/100mL
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 Fungi Nail Anti-Fungal Pen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 1 g/100mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55505-193-51 Fungi Nail Anti-Fungal Pen 3 mL in 1 TUBE, WITH APPLICATOR LIQUID 3 6 55505-193-51 Fungi Nail Anti-Fungal Pen 1 in 1 CARTON LIQUID 1 6 55505-193-60 Fungi Nail Anti-Fungal Pen 1 in 1 CARTON LIQUID 1 6 55505-193-60 Fungi Nail Anti-Fungal Pen 2 in 1 PACKAGE LIQUID 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55505-193 FUNGI NAIL ANTI-FUNGAL PEN (TOLNAFTATE) LIQUID [KRAMER LABORATORIES] 5 Current NDC, Legacy NDC, 4 package rows 20250323_1a0a3b14-d8f2-4363-b3c9-f5028e8eada3.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 41 of 49 · 969 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 55505-193-51 55505019351 1 TUBE, WITH APPLICATOR in 1 CARTON (55505-193-51) / 3 mL in 1 TUBE, WITH APPLICATOR 2020-03-01 0000-00-00 No No Current 55505-193-60 55505019360 2 CARTON in 1 PACKAGE (55505-193-60) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 3 mL in 1 TUBE, WITH APPLICATOR 2 carton 2021-05-18 No No Current