Home NDC 55505-219 Opti-Nail 2-in-1
Product NDC 55505-219
11-digit product format 555050219
Labeler code 55505
Product ID 55505-219_22f25809-6afc-43fc-81dc-de6745e20ab8
Type HUMAN OTC DRUG
Nonproprietary name Tolnaftate
Dosage form LIQUID
Route TOPICAL
Labeler Kramer Laboratories
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-20
Marketing end 2027-01-01
Substance TOLNAFTATE
Active strength 1 g/100mL
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 Opti-Nail 2-in-1 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313423 Internal RxNorm lookup 2627287 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 55505-219-67 Opti-Nail 2-in-1 5 mL in 1 TUBE, WITH APPLICATOR LIQUID 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55505-219 OPTI-NAIL 2-IN-1 (TOLNAFTATE) LIQUID [KRAMER LABORATORIES] 3 Current NDC, 1 package rows 20241228_bc8a5492-8bd0-4c80-a270-e4958aeb5ed6.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 55505-219-67 55505021967 5 mL in 1 TUBE, WITH APPLICATOR (55505-219-67) 5 ml 2023-01-20 2027-01-01 No No Historical