FDA.reportPublic FDA data

Antifungal Pen

Product NDC
85210-001
11-digit product format
852100001
Labeler code
85210
Product ID
85210-001_9e2dd8ab-e1b8-43fd-b156-f3788c591db4
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID 25%
Dosage form
LIQUID
Route
TOPICAL
Labeler
XF Agencija Limited
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-28
Substance
UNDECYLENIC ACID
Active strength
25 g/100mL
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
Antifungal Pen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998329Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a15d4512-0fc6-424f-9dd3-ab433d9b7a26Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85210-001-01Antifungal Pen1 in 1 CARTONLIQUID11
85210-001-01Antifungal Pen3 mL in 1 APPLICATORLIQUID31
85210-001-02Antifungal Pen3 mL in 1 APPLICATORLIQUID31
85210-001-02Antifungal Pen3 in 1 CARTONLIQUID31
85210-001-03Antifungal Pen6 in 1 CARTONLIQUID61
85210-001-03Antifungal Pen3 mL in 1 APPLICATORLIQUID31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85210-001ANTIFUNGAL PEN (UNDECYLENIC ACID 25%) LIQUID [XF AGENCIJA LIMITED]1Current NDC, 6 package rows20250129_a15d4512-0fc6-424f-9dd3-ab433d9b7a26.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 43 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Fungal TreatmentCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions278290f9-be14-81a8-e063-6294a90ad8cc2024-12-26WarningsExact identifier
application number: M005
DEO PEDICO ABOVE NEYMAR JR MENDEO PEDICO ABOVE NEYMAR JR MENBASTON INDUSTRIA DE AEROSSOIS LTDAed4a9844-f20b-da5d-e053-2995a90adc092024-12-26WarningsExact identifier
application number: M005
Vite20MICONAZOLE NITRATEBlaine Labs Inc.28a8d0dd-aab9-44ff-bab6-7ec4b5036a712024-12-24WarningsExact identifier
application number: M005
Vite20UNDECYLENIC ACIDBlaine Labs Inc.18f8ea1c-360e-43c0-98df-5816af4dec662024-12-24WarningsExact identifier
application number: M005
Tolnaftate Cream 1% ANTIFUNGALFAMILY WELLNESS TOLNAFTATETrifecta Pharmaceuticals USA, LLC915759af-0d7f-6a87-e053-2a95a90acbd62024-12-20WarningsExact identifier
application number: M005
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLERugby Laboratoriesa1365bc7-b376-adca-e053-2a95a90acf192024-12-20WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL MICONAZOLE POWDER SPRAYPremier Brands of America Inc.dc7a23bb-b246-89b1-e053-2995a90a9f2d2024-12-20WarningsExact identifier
application number: M005
Warrior Antifungal FootMICONAZOLE NITRATE 2%Derma Care Research Labs, LLCcf2e9dc1-275b-4454-e053-2995a90af2952024-12-20WarningsExact identifier
application number: M005
Tolnaftate Cream 1%TOLNAFTATEPharmacy Value Alliance, LLC.3abfd734-229b-1a0e-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M005
Dermatool Fungal Nail TreatmentTOLNAFTATE 1%Derma Care Research Labs, LLCfbc1a55e-b994-4962-e053-6394a90a13ba2024-12-19WarningsExact identifier
application number: M005
Novonail SolutionTOLNAFTATE 1%Derma Care Research Labs, LLC013d6107-e3b0-0264-e063-6394a90ae1e22024-12-19WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATERugbyf420de00-408f-9a2c-e053-2995a90adced2024-12-17WarningsExact identifier
application number: M005
Relispray Antifungal LiquidTOLNAFTATEMidas-Care Pharmaceuticals Pvt. Ltd.6522ad59-f810-408c-a9f9-9359d79302ce2024-12-17WarningsExact identifier
application number: M005
ClotrimazoleFAMILY WELLNESS CLOTRIMAZOLETrifecta Pharmaceuticals USA LLC915759af-0d7b-6a87-e053-2a95a90acbd62024-12-13WarningsExact identifier
application number: M005
Blistex Odor-Eaters PowderTOLNAFTATEBlistex Inc819edb2f-dda7-45c3-b0da-ebcae354154e2024-12-12WarningsExact identifier
application number: M005
Walgreens Athletes FootTOLNAFTATE SPRAYWalgreensc68ad65d-b016-0069-e053-2995a90ae7ef2024-12-11WarningsExact identifier
application number: M005
Dr. Rainer s Vaginal CreamMICONAZOLE NITRATEPlexoris Health Care Products, Llc1f0ee635-c70d-4194-a01d-370ca5c22fcd2024-12-11WarningsExact identifier
application number: M005
BOA VIDA AntifungalMICONAZOLE NITRATECentral Solutions Inc69c5340d-9abd-43bf-a90b-9568d615f06f2024-12-09WarningsExact identifier
application number: M005
BLUESEA DISPOSABLE HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTD7a552be2-a9e1-4c6f-b1c2-79113a73bd2f2024-12-06WarningsExact identifier
application number: M005
U HAND SANITIZER CLASSICBENZALKONIUM CHLORIDEBLUE SEA AEROSOL & DAILY CARE CO., LTDfbc27a24-0e81-4907-b24f-881c4fe0ec442024-12-06WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSNa15d4512-0fc6-424f-9dd3-ab433d9b7a261
998329undecylenic acid 250 MG/ML Topical SolutionSCDa15d4512-0fc6-424f-9dd3-ab433d9b7a261
998329undecylenic acid 25 % Topical SolutionSYa15d4512-0fc6-424f-9dd3-ab433d9b7a261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85210-001-01852100001011 APPLICATOR in 1 CARTON (85210-001-01) / 3 mL in 1 APPLICATOR1 applicator2025-01-28NoNoCurrent
85210-001-02852100001023 APPLICATOR in 1 CARTON (85210-001-02) / 3 mL in 1 APPLICATOR3 applicator2025-01-28NoNoCurrent
85210-001-03852100001036 APPLICATOR in 1 CARTON (85210-001-03) / 3 mL in 1 APPLICATOR6 applicator2025-01-28NoNoCurrent