FDA.reportPublic FDA data

Treatonic Antifungal Pen

Product NDC
85569-017
11-digit product format
855690017
Labeler code
85569
Product ID
85569-017_55b69f19-20f6-4203-e063-6394a90a43b0
Type
HUMAN OTC DRUG
Nonproprietary name
25% Undecylenic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
100 KARMA INC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-18
Substance
UNDECYLENIC ACID
Active strength
2.25 g/9g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Treatonic Antifungal Pen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID2.25 g/9g

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
1362039Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52d89172-e8a7-70c0-e063-6294a90a3563Available on FDA.report

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 29 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-Fungal PowderMICONAZOLE NITRATETopCo Associates19c3fbc5-abde-57df-e063-6394a90a125c2025-11-06WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYTopco Associates LLC17993a9f-0d44-43a1-8608-94ee8a08b5392025-11-06WarningsExact identifier
application number: M005
DVO Estriol creamESTRIOL0.2%Guangzhou Huixue Biotechnology Co., Ltd.42e4cc84-7c00-6937-e063-6294a90a0c092025-11-05WarningsExact identifier
application number: M005
MedlineMICONAZOL NITRATEMedline Industries, LPdad58efb-cc20-577a-e053-2a95a90abd9d2025-11-03WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYHEBc6af941a-0b85-4611-a6f3-b13fcf3c4a872025-11-03WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYHEBc585605b-ecb8-4dd8-9205-a9be02d751fa2025-11-03WarningsExact identifier
application number: M005
Premier Solutions Antifungal Tolnaftate LiquidTOLNAFTATEPremier Brands of America, Inc.e1971c1c-5687-577b-e053-2a95a90ad95f2025-11-03WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYPremier Brands of America Inc.3803c643-35d1-06d4-e063-6294a90ac6f62025-11-03WarningsExact identifier
application number: M005
Anti-fungal Powder Miconazole NitrateMICONAZOLE NITRATEMeijer Distribution Inc03fd069d-685d-b8ac-e063-6394a90a31f82025-10-31WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYPremier Brands of America Inc.7a6a63cd-e87d-4229-8acf-b65d63909eb62025-10-31WarningsExact identifier
application number: M005
AzolenMICONAZOLE NITRATEStratus Pharmaceuticals, Inc.9c2574f3-3be4-405a-9c87-943dc6ef87772025-10-30WarningsExact identifier
application number: M005
Family Care AntifungalCLOTRIMAZOLEUnited Exchange Corp.63255079-ecf1-1e77-e053-2a91aa0a7b6c2025-10-30WarningsExact identifier
application number: M005
Miconazorb AFMICONAZOLE NITRATEAmerisourceBergen Drug Corporation13a20d21-42d5-fe56-e063-6394a90aaf572025-10-30WarningsExact identifier
application number: M005
Antifungal Liquid ContinuousMICONAZOLE NITRATEFamily Dollar Services, Inc17cc4601-f946-df8b-e063-6394a90a38972025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYARMY & AIR FORCE EXCHANGE SERVICE932b1be8-3dbb-49ae-822a-c44a24fbe36a2025-10-30WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYGEISS, DESTIN AND DUNN, INC.c367c2e8-5423-bf01-e053-2a95a90ab8e92025-10-30WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYHarris Teeter, LLC636b0d6f-4e36-4c96-9e71-7bfdebb7f3cb2025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYHarris Teeter, LLCf140e9bb-507b-4048-8b7b-8cc51b6a497d2025-10-30WarningsExact identifier
application number: M005
HEB Athlete Foot AntifungalMICONAZOLE NITRATEHEB2e204111-b5d3-0220-e063-6294a90a67bb2025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL SPRAY LIQUIDKroger Co.0cfebac3-684d-4599-b75f-9a82708db7172025-10-30WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85569-017-01855690017013 BOTTLE, DROPPER in 1 CARTON (85569-017-01) / 3 g in 1 BOTTLE, DROPPER2026-06-18NoNoCurrent