Treatonic Nailtonic Repair Pens

Product NDC
85569-015
11-digit product format
855690015
Labeler code
85569
Product ID
85569-015_55b683b8-9807-67b7-e063-6294a90a6af9
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
2026-03-05
Substance
UNDECYLENIC ACID
Active strength
11.25 g/45g
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 Nailtonic Repair Pens
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID11.25 g/45g

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
4a9c32b3-e78d-3c85-e063-6394a90a7bf2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85569-015-01Treatonic Nailtonic Repair Pens45 g in 1 CARTONGEL451

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 6 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOVS MULTI-PURPOSE NAIL REPAIRTOLNAFTATE 1% MULTI-PURPOSE NAIL REPAIRWenzhou Yuyuan Pharmaceutical Co., Ltd.56df87a7-7fc2-5ba4-e063-6394a90a652b2026-07-18WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c93390-ee07-4f78-e063-6394a90add422026-07-17WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kitPSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56cb7085-87d8-4273-e063-6394a90ac5df2026-07-17WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT CARETOLNAFTATE 1% ANTIFUNGAL FOOT CAREWenzhou Yuyuan Pharmaceutical Co., Ltd.56b10492-894c-33e1-e063-6394a90a8c0f2026-07-17WarningsExact identifier
application number: M005
Foot Choice-Nail Fungal PenUNDECYLENIC ACIDFoot Choice LLC4b0036a6-8751-4f44-b6b1-5be57fa92cdc2026-07-17WarningsExact identifier
application number: M005
2% MICONAZOLE NITRATE ANTIFUNGAL Cream2% MICONAZOLE NITRATE ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd56b54359-db21-b8b4-e063-6394a90a6f8c2026-07-16WarningsExact identifier
application number: M005
DRAVYNOR BALANITIS RELIEF CreamMICONAZOLE NITRATE 2% BALANITIS RELIEF CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.56b76a52-0743-4fe6-e063-6294a90a98a82026-07-16WarningsExact identifier
application number: M005
5% Benzoyl Peroxide FOLLICULITIS Cream5% BENZOYL PEROXIDE FOLLICULITIS CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd56c558fa-303f-fc52-e063-6394a90a72f02026-07-16WarningsExact identifier
application number: M005
Antifungal Ringworm Treatment CreamMICONAZOLE NITRATEYunqi Cosmetics (Shenzhen) Co., Ltd56a2ceea-c4c0-c30c-e063-6394a90a0e6a2026-07-15WarningsExact identifier
application number: M005
Medi-First Antifungal Cream Miconazole CreamMICONAZOLEUnifirst First Aid Corporation56a51b75-9c23-bcd2-e063-6394a90a9b122026-07-15WarningsExact identifier
application number: M005
Clear Root Labs Tinea TreatmentCLEAR ROOT LABS TINEA TREATMENTAidance Scientic Inc., DBA Aidance Skincare & Topicals56a67bad-c677-d3b7-e063-6394a90ad2052026-07-15WarningsExact identifier
application number: M005
Clear Root Labs Antifungal TreatmentCLEAR ROOT LABS ANTIFUNGAL TREATMENTAidance Scientific, Inc., DBA Aidance Skincare & Topicals5696bf23-230a-5f37-e063-6294a90a74132026-07-15WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL NAIL LiquidTOLNAFTATE 1% ANTIFUNGAL NAIL LIQUIDJiangxi Yudexi Pharmaceutical Co., LTD56b17e50-bff1-5eb0-e063-6294a90a3c082026-07-15WarningsExact identifier
application number: M005
terrasil Antifungal Cleansing BarCLOTRIMAZOLEAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions10a4fde0-87e1-4474-bcb5-255b0a7f1ecb2026-07-14WarningsExact identifier
application number: M005
OAKDOLCHE Tea Tree Oil AntifungalTOLNAFTATENanjing Qiaotun Technology Co., Ltd.569dee15-e68d-220e-e063-6294a90af7c52026-07-14WarningsExact identifier
application number: M005
Kimtara Nail Fungus TreatmentKIMTARA NAIL FUNGUS TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5678e260-10c4-f203-e063-6294a90a62232026-07-13WarningsExact identifier
application number: M005
Aiilo NAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.5689ac31-4d23-0fcc-e063-6394a90ac75b2026-07-13Exact identifier
application number: M005
MIWIFY ANTIFUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.56519b25-f3c8-bcac-e063-6394a90af8792026-07-11WarningsExact identifier
application number: M005
Joymeey FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5652a22e-7b43-3c31-e063-6294a90ae4f12026-07-11WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2677690tolnaftate 1 % Medicated PatchPSN4c197131-9ca8-6024-e063-6294a90aa9cb1
1362039undecylenic acid 25 % Topical GelPSN4a9c32b3-e78d-3c85-e063-6394a90a7bf21
1362039undecylenic acid 25 % Topical GelPSN4c197131-9ca8-6024-e063-6294a90aa9cb1
2677690tolnaftate 0.01 MG/MG Medicated PatchSCD4c197131-9ca8-6024-e063-6294a90aa9cb1
1362039undecylenic acid 0.25 MG/MG Topical GelSCD4a9c32b3-e78d-3c85-e063-6394a90a7bf21
1362039undecylenic acid 0.25 MG/MG Topical GelSCD4c197131-9ca8-6024-e063-6294a90aa9cb1
2677690tolnaftate 1 % Medicated PatchSY4c197131-9ca8-6024-e063-6294a90aa9cb1
1362039undecylenic acid 25 % Topical GelSY4a9c32b3-e78d-3c85-e063-6394a90a7bf21
1362039undecylenic acid 25 % Topical GelSY4c197131-9ca8-6024-e063-6294a90aa9cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85569-015-018556900150145 g in 1 CARTON (85569-015-01) 45 g2026-03-05NoNoCurrent