Home NDC 59088-279 Mycozyl HC Cream Gel
Product NDC 59088-279
11-digit product format 590880279
Labeler code 59088
Product ID 59088-279_137f9cc1-68c5-edcc-e063-6394a90abf6a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolnaftate, Hydrocortisone
Dosage form GEL
Route TOPICAL
Labeler PURETEK CORPORATION
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-03-14
Substance TOLNAFTATE; HYDROCORTISONE
Active strength 10; 6.67 mg/g; mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 HC Cream Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLNAFTATE 10 mg/g HYDROCORTISONE 6.67 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 06KB629TKV Internal UNII lookup WI4X0X7BPJ Internal UNII 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 59088-279-03 Mycozyl HC Cream Gel 28 g in 1 TUBE GEL 28 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-279 MYCOZYL HC CREAM GEL (TOLNAFTATE, HYDROCORTISONE) GEL [PURETEK CORPORATION] 1 Current NDC, 1 package rows 20240316_137f9cc1-68c6-edcc-e063-6394a90abf6a.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59088-279-03 59088027903 28 g in 1 TUBE (59088-279-03) 28 g 2024-03-14 No No Current