FDA.reportPublic FDA data

APUREE Nailtific Extra-Max Strength Daytime Antigungal

Product NDC
84167-423
11-digit product format
841670423
Labeler code
84167
Product ID
84167-423_4e3d226b-57f2-75a6-e063-6394a90a96cd
Type
HUMAN OTC DRUG
Nonproprietary name
APUREE Nailtific Extra-Max Strength Daytime Antigungal
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangzhou Meixi Biotechnology Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-30
Substance
TOLNAFTATE; UNDECYLENIC ACID
Active strength
1; 25 g/1; g/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct84167-423DDiscontinued by firm2026-10-15
excluded packagepackage84167-42384167-423-03DDiscontinued by firm2026-10-15

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
APUREE Nailtific Extra-Max Strength Daytime Antigungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/1
UNDECYLENIC ACID25 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup
K3D86KJ24NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2691548Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e3d226b-57f1-75a6-e063-6394a90a96cdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84167-423-01APUREE Nailtific Extra-Max Strength Daytime Antigungal1 in 1 BOXLIQUID11
84167-423-01APUREE Nailtific Extra-Max Strength Daytime Antigungal30 in 1 VIAL, SINGLE-USELIQUID301

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 34 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEAvPAK3ca3b475-7b69-442a-e063-6294a90a7b3f2025-08-18WarningsExact identifier
application number: M005
Formula 3TOLNAFTATEThe Tetra Corporation0895274b-a09d-4264-a43f-852e44eb31632025-08-18WarningsExact identifier
application number: M005
Formula 7 - The SolutionTOLNAFTATEThe Tetra Corporation18619649-7f79-4b6e-8b7c-69d70365d5572025-08-18WarningsExact identifier
application number: M005
GlyCylicSALICYLIC ACIDThe Tetra Corporation501d3ba9-ba42-4c1c-983b-492adaee039d2025-08-18WarningsExact identifier
application number: M005
SupreH Ringworm Treatment BalmSUPREH RINGWORM TREATMENT BALMShenzhen Xinxin Yunhai Technology Co., Ltd.3c77222b-d92e-84b0-e063-6294a90aadd72025-08-16WarningsExact identifier
application number: M005
OetMoe Antifungal SolutionOETMOE ANTIFUNGAL SOLUTIONShenzhen Earth Surface Trading Co., Ltd.3c26d917-4186-6f02-e063-6394a90a99f62025-08-12WarningsExact identifier
application number: M005
Cureforte Anti Fungal Foot CareANTI FUNGAL FOOT CARE DROPSSTEEL CITY HEALTH PRIVATE LIMITED39f762a6-9d0c-8ded-e063-6394a90a36592025-08-11WarningsExact identifier
application number: M005
Derman Antifungal Powder TolnaftateTOLNAFTATETaisho Pharmaceutical California Inc.3a854765-740c-4719-8abf-4b3f932cdee02025-08-07WarningsExact identifier
application number: M005
Derman antifungal creamTOLNAFTATETaisho Pharmaceutical California Inc.15d9b3c9-01af-4083-a1bc-014505d8798d2025-08-07WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEHudson Health LLC24b22794-f9f8-6f32-e063-6394a90aec982025-08-07WarningsExact identifier
application number: M005
Toe Area TreatmentTOLNAFTATECVS17681cc8-fbb1-a0cf-e063-6294a90add182025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc178e7b3f-949f-3f51-e063-6294a90a93952025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATELEADER/Cardinal Health 110, Inc.17695563-3765-74cb-e063-6294a90a61202025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETarget Corporation1dff278f-47bc-459a-e063-6394a90a26462025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETopCo Associates19c268a1-7b2e-63c9-e063-6394a90acddc2025-08-07WarningsExact identifier
application number: M005
Antifungal Liquid Maximum StrengthTOLNAFTATEWalgreens Company137eabb7-cb4f-1631-e063-6294a90ab8472025-08-07WarningsExact identifier
application number: M005
WCTNGO Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad0d73-b33d-b962-e063-6294a90a7ba72025-08-06WarningsExact identifier
application number: M005
ONIADBA Nail Fungus Treatment PenTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad19f1-d5b3-c5de-e063-6294a90a0c032025-08-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEPremier Brands of America Inc2644ba07-aaee-6402-e063-6394a90a28272025-08-06WarningsExact identifier
application number: M005
Anti- Fungal Miconazole NitrateMICONAZOLE NITRATEPremier Brands of America Inc.f186bdc1-db6c-0fab-e053-2995a90a7c582025-08-06WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN4e3d226b-57f1-75a6-e063-6394a90a96cd1
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD4e3d226b-57f1-75a6-e063-6394a90a96cd1
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY4e3d226b-57f1-75a6-e063-6394a90a96cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84167-423-01841670423011 VIAL, SINGLE-USE in 1 BOX (84167-423-01) / 30 LIQUID in 1 VIAL, SINGLE-USE2026-03-30NoNoCurrent