FDA.reportPublic FDA data

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
IngredientStrength
TOLNAFTATE.3 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313423Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b82c9a8a-f6f1-dca6-e053-2995a90a47f9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-443-03Mycozyl AL30 mL in 1 BOTTLE, WITH APPLICATORLIQUID303
59088-443-03Miconatate30 mL in 1 BOTTLE, WITH APPLICATORLIQUID1 mL in 300.3 g in 30mL3
59088-443-01Mycozyl AL10 mL in 1 BOTTLELIQUID101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-443-03ML - Milliliter59088-443958250a3-49e2-439f-998a-bf21bf22ea5212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-443MICONATATE (MICONAZOLE NITRATE AND TOLNAFTATE) KIT [PURETEK CORPORATION]3Current NDC, Legacy NDC20241018_c45c8f8f-9042-a428-e053-2a95a90acda9.zip
59088-443MYCOZYL AL (TOLNAFTATE) LIQUID [PURETEK CORPORATION]3Current NDC, Legacy NDC, 1 package rows20241004_b82c9a8a-f6f1-dca6-e053-2995a90a47f9.zip
59088-443MYCOZYL AL (TOLNAFTATE) LIQUID [PURETEK CORPORATION]1Current NDC, Legacy NDC, 1 package rows20231018_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 28 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cura Hongo AntifungalCLOTRIMAZOLEPharmadel LLCdf031309-2778-00cf-e053-2a95a90a5eea2025-11-17WarningsExact identifier
application number: M005
CharmTex All in One Antibacterial Shave Gel Body WashBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltda7433f39-a8d9-4c78-864d-d7ef193a7daf2025-11-16WarningsExact identifier
application number: M005
Mint Blast Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLCf7fcac19-7b72-4b7a-a28e-669a0eebec9c2025-11-15WarningsExact identifier
application number: M005
Lavender Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLC9db58924-a84d-4763-badb-b3aeb46e1ea62025-11-15WarningsExact identifier
application number: M005
Citrus Detox Foot and Shoe AntifungalUNDECYLENIC ACID 10%SANSAR, LLC6585c9f5-a6cb-4534-9a61-ecbb6dcb7bdc2025-11-15WarningsExact identifier
application number: M005
AlphaTip Nail Repair PenNAIL REPAIR PENGuangzhou Qiexiran Cosmetics Co., Ltd.435c7973-8a67-8f51-e063-6394a90af58f2025-11-11WarningsExact identifier
application number: M005
Pharmlitalia Antifungal Medicated BodyTOLNAFTATEFoshan Sugar Max Cosmetics CO.,Ltd399302d2-0da4-4167-8884-b34a9aba86862025-11-10WarningsExact identifier
application number: M005
PerfectHeal AntifungalCLOTRIMAZOLEZhejiang Dingtai Pharmaceutical Co., Ltdd9750991-8f10-4d6b-8841-bea022d5ad732025-11-10WarningsExact identifier
application number: M005
PiYanPing AntifungalMICONAZOLE NITRATEZhejiang Dingtai Pharmaceutical Co., Ltd840364aa-d799-4163-a9e8-3f10c18f86ae2025-11-10WarningsExact identifier
application number: M005
SKINHEAL ANTIFUNGALTOLNAFTATEZhejiang Dingtai Pharmaceutical Co., Ltd570ee9fb-a495-4a99-9215-0cd1bb2e02902025-11-10WarningsExact identifier
application number: M005
HUA TUO XIAN GAO ANTIFUNGALCLOTRIMAZOLEMADISON ONE ACME INCe11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d2025-11-10WarningsExact identifier
application number: M005
Selan AntifungalSELAN ANTIFUNGALTrividia Manufacturing Solutions, Inc8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a292025-11-07WarningsExact identifier
application number: M005
Fortinia UltraCLOTRIMAZOLE 1%The Podiatree Company43065a59-fb81-b1c2-e063-6294a90a36e02025-11-07WarningsExact identifier
application number: M005
MICOCLEARCLOTRIMAZOLE ANTIFUNGALRising Pharma Holdings, Inc.d75b7d3c-3f1c-47e1-8122-4645f56a444e2025-11-06WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP1ea444eb-f2f5-8c63-e063-6294a90acac82025-11-06WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL POWDER SPRAYPremier Brands of America Inc.38ccf19c-2290-ad99-e063-6394a90a54692025-11-06WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL POWDER SPRAY WITH BAKING SODATarget Corporation37792b12-c3dc-558f-e063-6294a90a7e752025-11-06WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYTopco Associates LLC5f8ae9ab-5e34-7a60-e053-2991aa0a98172025-11-06WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATE JOCK ITCH POWDER SPRAY TALC FREETopco Associates LLC5f8ac6b7-c46c-226c-e053-2991aa0a96062025-11-06WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYTopco Associates LLC3dd0df06-3c74-4c34-a69e-4240945f5fa52025-11-06WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSNc45c8f8f-9042-a428-e053-2a95a90acda93
313423tolnaftate 1 % Topical SolutionPSNb82c9a8a-f6f1-dca6-e053-2995a90a47f93
313423tolnaftate 1 % Topical SolutionPSNc45c8f8f-9042-a428-e053-2a95a90acda93
998461miconazole nitrate 0.02 MG/MG Topical PowderSCDc45c8f8f-9042-a428-e053-2a95a90acda93
313423tolnaftate 10 MG/ML Topical SolutionSCDb82c9a8a-f6f1-dca6-e053-2995a90a47f93
313423tolnaftate 10 MG/ML Topical SolutionSCDc45c8f8f-9042-a428-e053-2a95a90acda93
998461miconazole nitrate 2 % Topical PowderSYc45c8f8f-9042-a428-e053-2a95a90acda93
313423tolnaftate 1 % Topical SolutionSYb82c9a8a-f6f1-dca6-e053-2995a90a47f93
313423tolnaftate 1 % Topical SolutionSYc45c8f8f-9042-a428-e053-2a95a90acda93
313423tolnaftate 1 % Topical SolutionPSN07edd043-4ac4-b2de-e063-6394a90af25d1
313423tolnaftate 10 MG/ML Topical SolutionSCD07edd043-4ac4-b2de-e063-6394a90af25d1
313423tolnaftate 1 % Topical SolutionSY07edd043-4ac4-b2de-e063-6394a90af25d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-443-015908804430110 mL in 1 BOTTLE (59088-443-01) 10 ml2023-10-17NoNoCurrent
59088-443-035908804430330 mL in 1 BOTTLE, WITH APPLICATOR (59088-443-03) 30 ml2021-06-090000-00-00NoNoCurrent