FDA.reportPublic FDA data

CLARUS AC Antifungal Solution

Product NDC
44577-128
11-digit product format
445770128
Labeler code
44577
Product ID
44577-128_09d7052e-ec64-ef60-e063-6294a90af214
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Clinical Therapeutic Solutions
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-01
Substance
TOLNAFTATE
Active strength
10 mg/g
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
CLARUS AC Antifungal Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

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
28ab9f1b-65cd-4405-a9a3-f3c9b836693dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44577-128-00CLARUS AC Antifungal Solution15 g in 1 TUBELIQUID152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44577-128CLARUS AC ANTIFUNGAL SOLUTION (TOLNAFTATE) LIQUID [CLINICAL THERAPEUTIC SOLUTIONS]2Current NDC, Legacy NDC, 1 package rows20231111_28ab9f1b-65cd-4405-a9a3-f3c9b836693d.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 · 973 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
313423tolnaftate 1 % Topical SolutionPSN28ab9f1b-65cd-4405-a9a3-f3c9b836693d2
313423tolnaftate 10 MG/ML Topical SolutionSCD28ab9f1b-65cd-4405-a9a3-f3c9b836693d2
313423tolnaftate 1 % Topical SolutionSY28ab9f1b-65cd-4405-a9a3-f3c9b836693d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44577-128-004457701280015 g in 1 TUBE (44577-128-00) 15 g2021-03-010000-00-00NoNoCurrent