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 21 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terramed Just Think Comfort Armor Antifungal MedicatedTOLNAFTATERida LLC33994035-b429-4ead-8885-98e38b25059a2026-02-04WarningsExact identifier
application number: M005
BeamBalm FUNGL NAILTOLNAFTATE 1% FUNGL NAILJiangxi Yudexi Pharmaceutical Co., LTD49f72e97-2393-dca8-e063-6394a90a6f102026-02-03WarningsExact identifier
application number: M005
MARIANP FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.49d1dbc4-91be-1f5c-e063-6394a90a55ec2026-02-02WarningsExact identifier
application number: M005
Jorvinl Nail Fungus TreatmentUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.49d88844-9cb0-f575-e063-6394a90a0d2f2026-02-02WarningsExact identifier
application number: M005
FlyLeaf Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.49d8e823-b7a2-8c18-e063-6294a90a77452026-02-02WarningsExact identifier
application number: M005
BLDAXN FUNGUS NAIL PENUNDECYLENIC ACID, TOLNAFTATEGuangdong Quadrant Ecological Technology Co., Ltd.49e291e1-be83-8926-e063-6394a90a13c22026-02-02WarningsExact identifier
application number: M005
INSTANT HAND SANITIZERINSTANT HAND SANITIZERNINGBO MEITELI COSMETICS CO., LTD49e44671-5d79-aa8e-e063-6294a90a9d2e2026-02-02WarningsExact identifier
application number: M005
Alveora FOOT ODOR PROBIOTICTOLNAFTATE 1% FOOT ODOR PROBIOTICJiangxi Yudexi Pharmaceutical Co., LTD49964c81-1c86-e1f5-e063-6394a90a7d082026-01-30WarningsExact identifier
application number: M005
Alveora NAIL FUNGUS TREATMENTALVEORA NAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD49985b01-ef96-0d27-e063-6294a90ac1692026-01-30WarningsExact identifier
application number: M005
ProClearz Laser AntifungalTOLNAFTATERooftop Consumer Health, inc53648135-7b79-4775-993b-48fa1298b7472026-01-29WarningsExact identifier
application number: M005
Proclearz Professional Fungal ShieldTOLNAFTATERooftop Consumer health, inc51125209-c279-4abb-af07-500982651cab2026-01-29WarningsExact identifier
application number: M005
TheraCare Antifungal CreamTOLNAFTATEVeridian Healthcaree9478d74-c0d9-4b88-a474-b88d10f525712026-01-29WarningsExact identifier
application number: M005
BLDAXN NAIL REPAIR PENUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4992fbd8-f205-2ff6-e063-6394a90a7d062026-01-29WarningsExact identifier
application number: M005
Jock Itch Clotrimazole AntifungalCLOTRIMAZOLEWalMarta7677ad4-5239-40da-809a-501b91caedbf2026-01-29WarningsExact identifier
application number: M005
ProCure AntifungalMICONAZOLE NITRATE 2%Twin Med LLC3d380fe4-a870-cb55-e063-6394a90a9c902026-01-28WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWal-Mart Stores, Inc.401f4993-0200-f1fd-e063-6294a90a65892026-01-28WarningsExact identifier
application number: M005
Foot PowderMICONAZOLE NITRATEWalgreens Company137a493b-6ed5-d649-e063-6294a90ac4422026-01-28WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYWal-Mart Stores, Inc.76259769-9923-4856-a160-a738bc8a72f02026-01-27WarningsExact identifier
application number: M005
Signature Select Instant Hand Sanitizer Wipes with Aloe VeraALCOHOLLiving Better Brands LLCcf4b671f-697a-47d3-921e-2de4330739182026-01-26WarningsExact identifier
application number: M005
Signature Select Advanced Hand Sanitizer with Aloe VeraALCOHOLLiving Better Brands LLCcbf0fead-0729-460b-82c0-1596c995cf2b2026-01-26WarningsExact 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