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 40 of 49 · 969 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HAND SANITIZER ALCOHOL NINGBO TIANBO FIRST AID PRODUCT CO., LTD. 88a14b15-09d6-45de-97b6-cddce7ca420b 2025-04-19 Warnings Exact identifier application number: M005 ELLEN HAND SANITIZER ETHYL ALCOHOL PT. SUPER HOME PRODUCT INDONESIA 33077eab-e686-249d-e063-6394a90a1b6d 2025-04-18 Warnings Exact identifier application number: M005 MEDI-FIRST First Aid Antiseptic BENZALKONIUM CHLORIDE Ultra Distributors Inc b6efaca5-49d0-b000-e053-2995a90ab9aa 2025-04-07 Warnings Exact identifier application number: M005 ANTIBACTERIAL HAND SANITIZER ETHYL ALCOHOL ASC Marketing Ltd. b42ebe64-0cad-2d26-e053-2a95a90af3dd 2025-04-07 Warnings Exact identifier application number: M005 Anti-Bacterial HAND SANITIZER ETHYL ALCOHOL DISNEY DESTINATIONS,LLC ae739bda-edf3-634b-e053-2a95a90a7385 2025-04-07 Warnings Exact identifier application number: M005 Hand Sanitizer ETHYL ALCOHOL Orazen Inc aa846bb7-a64b-3358-e053-2995a90a9d09 2025-04-07 Warnings Exact identifier application number: M005 Hand Sanitizer ETHYL ALCOHOL Orazen Inc 9ae42862-f730-9d67-e053-2a95a90af955 2025-04-07 Warnings Exact identifier application number: M005 Hand Sanitizer ETHYL ALCOHOL Orazen Inc 7e8f4517-c996-8797-e053-2991aa0a4f58 2025-04-07 Warnings Exact identifier application number: M005 Hand Sanitizer ETHYL ALCOHOL Raining Rose, Inc. 43ab2651-6e0a-3d48-e054-00144ff88e88 2025-04-07 Warnings Exact identifier application number: M005 Folliculitis Treatment Cream MICONAZOLE NITRATE TAGRID LLC 32396be0-f74a-5483-e063-6294a90ab3ae 2025-04-07 Warnings Exact identifier application number: M005 Antifungal Treatment Liquid 25 undeclylenic Acid UNDECYLENIC ACID SANSAR, LLC 2ae0f300-154e-44c8-bcc3-b5c334e661ac 2025-04-02 Warnings Exact identifier application number: M005 BBlove ALCOHOL WIPES BBLOVE ALCOHOL WIPES Shenzhen Shierjie Biological Engineering Co., LTD 3126955d-8fd1-04f8-e063-6294a90a886f 2025-03-31 Warnings Exact identifier application number: M005 Tagrid Jock Itch Miconazole Nitrate 2% MICONAZOLE NITRATE TAGRID LLC 31abdc68-5027-15e7-e063-6394a90ac4e6 2025-03-31 Warnings Exact identifier application number: M005 Tea Tree Oil Foot Soak and Body Soak ZINC UNDECYLENATE SANSAR, LLC c43816ac-2228-43ce-ba45-80cf3a7788f2 2025-03-28 Warnings Exact identifier application number: M005 health beyond HAND SANITIZER ALCOHOL Nantong Health & Beyond Hygienic Products Inc. e5746be7-e9dc-42a6-a3d0-b386427caec5 2025-03-27 Warnings Exact identifier application number: M005 Tagrit Antifungal Treament Ketoconazole 1% KETOCONAZOLE TAGRID LLC 315a8832-c42f-c07a-e063-6394a90a8218 2025-03-27 Warnings Exact identifier application number: M005 1236-CS Antifungal Powder (Talc Free) 1236-CCANTIFUNGAL POWDER(TALC FREE) Dynarex Corporation 312ba573-4008-83e6-e063-6294a90a4a6d 2025-03-25 Warnings Exact identifier application number: M005 Antifungal Medicated Bar TOLNAFTATE RoyceDerm LLC 31305ed2-a0a0-6d4c-e063-6294a90a6ba5 2025-03-25 Warnings Exact identifier application number: M005 Forticept Antimicrobial Hydrogel Wound Dressing BENZETHONIUM CHLORIDE, THYMOL Lidan, Inc cd5b7a72-1b87-434d-973e-071d2c8a438c 2025-03-25 Warnings Exact identifier application number: M005 Forticept HP Antiseptic Wound Cleanser BENZALKONIUM CHLORIDE, ALLANTOIN Lidan, inc. 41bb46ee-edce-4e1b-bcfd-5c5729e1eb15 2025-03-25 Warnings Exact identifier application number: M005
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