Home NDC 59088-443 Mycozyl AL
Product NDC 59088-443
11-digit product format 590880443
Labeler code 59088
Product ID 59088-443_07edd043-4ac5-b2de-e063-6394a90af25d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolnaftate
Dosage form LIQUID
Route TOPICAL
Labeler PURETEK CORPORATION
Application M005
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2023-10-17
Substance TOLNAFTATE
Active strength .1 g/10mL
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 Mycozyl AL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE .3 g/30mL
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 59088-443-03 Mycozyl AL 30 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 30 3 59088-443-03 Miconatate 30 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 1 mL in 30 0.3 g in 30mL 3 59088-443-01 Mycozyl AL 10 mL in 1 BOTTLE LIQUID 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-443 MICONATATE (MICONAZOLE NITRATE AND TOLNAFTATE) KIT [PURETEK CORPORATION] 3 Current NDC, Legacy NDC 20241018_c45c8f8f-9042-a428-e053-2a95a90acda9.zip 59088-443 MYCOZYL AL (TOLNAFTATE) LIQUID [PURETEK CORPORATION] 3 Current NDC, Legacy NDC, 1 package rows 20241004_b82c9a8a-f6f1-dca6-e053-2995a90a47f9.zip 59088-443 MYCOZYL AL (TOLNAFTATE) LIQUID [PURETEK CORPORATION] 1 Current NDC, Legacy NDC, 1 package rows 20231018_07edd043-4ac4-b2de-e063-6394a90af25d.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 49 · 974 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 59088-443-01 59088044301 10 mL in 1 BOTTLE (59088-443-01) 10 ml 2023-10-17 No No Current 59088-443-03 59088044303 30 mL in 1 BOTTLE, WITH APPLICATOR (59088-443-03) 30 ml 2021-06-09 0000-00-00 No No Current