FDA.reportPublic FDA data

Micomitin Antifungal

Product NDC
59088-640
11-digit product format
590880640
Labeler code
59088
Product ID
59088-640_249cb373-baaf-ac39-e063-6294a90a591b
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
LIQUID
Route
TOPICAL
Labeler
PureTek Corporation
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-30
Substance
TOLNAFTATE
Active strength
.3 g/30mL
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
Micomitin Antifungal
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
de9842ba-0254-8ae1-e053-2995a90a0664Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-640-03Micomitin Antifungal30 mL in 1 BOTTLELIQUID303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-640-03ML - Milliliter59088-640d6e8dd0b-585d-4513-9334-a69c3cad7b5812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-640MICOMITIN ANTIFUNGAL (TOLNAFTATE) LIQUID [PURETEK CORPORATION]3Current NDC, 1 package rows20241018_de9842ba-0254-8ae1-e053-2995a90a0664.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 11 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEChain Drug Marketing Association327095bd-a7c9-291d-e063-6394a90afafa2026-06-09WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYChain Drug Marketing Association34b5c11f-710f-60e4-e063-6394a90a990d2026-06-09WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYChain Drug Marketing Association342affe8-0a4d-6fe6-e063-6394a90a8dad2026-06-09WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEChain Drug Marketing Associationedc2da26-ae46-4175-86ed-83e1a65f6d142026-06-09WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYChain Drug Marketing Associationaa97d2ca-bcf4-3ee1-e053-2a95a90a748d2026-06-09WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYChain Drug Marketing Association1bd8e096-1717-4656-b52c-086d2f56f0702026-06-09WarningsExact identifier
application number: M005
BODYKOO JOCK ITCH CreamCLOTRIMAZOLE1% JOCK ITCH CREAMJiangxi Yudexi Pharmaceutical Co., LTD53553b31-81bb-d293-e063-6294a90aa0a52026-06-09WarningsExact identifier
application number: M005
BODYKOO ATHLETE FOOT CreamMICONAZOLE NITRATE2% ATHLETE FOOT CREAMJiangxi Yudexi Pharmaceutical Co., LTD53561903-54fe-f8ec-e063-6294a90a19fe2026-06-09WarningsExact identifier
application number: M005
Clotrimazole CreamCLOTRIMAZOLE USP1%Aldermed Inc.53bdd76b-6290-f1d3-e063-6394a90a9ff12026-06-08WarningsExact identifier
application number: M005
Miconazole CreamMICONAZOLE NITRATEAldermed Inc.4a7fc48a-c103-dc84-e063-6394a90ab80f2026-06-08WarningsExact identifier
application number: M005
Antifungal PowderMICONAZOLE NITRATEAldermed Inc.60954089-5220-4f4c-8595-b5ee4562562c2026-06-08WarningsExact identifier
application number: M005
Jock Itch PowderMICONAZOLE NITRATEWalgreens Company06d2f36c-8615-af08-e063-6394a90aa4242026-06-05WarningsExact identifier
application number: M005
Miconazole Nitrate 2%JOCK ITCH SPRAYWalgreens Companycf6cbaf4-beba-6fdf-e053-2995a90a76d22026-06-04WarningsExact identifier
application number: M005
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD5368b131-7537-8679-e063-6394a90a67542026-06-04WarningsExact identifier
application number: M005
Nail Fungus Treatment PenUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe842e1-b3db-c003-e063-6394a90a46b82026-06-04WarningsExact identifier
application number: M005
Lasolex ACMICONAZOLE NITRATE 2% ANTIFUNGALPureTek Corporation52bb4bc1-e88f-f5ea-e063-6394a90ae1e82026-06-03WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.13a14d3c-bfce-42b5-8463-4ec69e94774e2026-06-03WarningsExact identifier
application number: M005
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd43cbad59-9899-ab3b-e063-6294a90a9e122026-06-02WarningsExact identifier
application number: M005
Athletes Foot CreamCLOTRIMAZOLEShenzhen Miandou Technology Co.,Ltd.53451e74-719e-9499-e063-6394a90a9e5a2026-06-02WarningsExact identifier
application number: M005
Lasolex ALMICONAZOLE NITRATE 2% ANTIFUNGALPureTek Corporation534df9be-b47a-03a1-e063-6394a90a265a2026-06-02WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSNde9842ba-0254-8ae1-e053-2995a90a06643
313423tolnaftate 10 MG/ML Topical SolutionSCDde9842ba-0254-8ae1-e053-2995a90a06643
313423tolnaftate 1 % Topical SolutionSYde9842ba-0254-8ae1-e053-2995a90a06643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-640-035908806400330 mL in 1 BOTTLE (59088-640-03) 30 ml2023-08-30NoNoCurrent