FDA.reportPublic FDA data

AlphaTip Nail Repair Pen

Product NDC
85817-008
11-digit product format
858170008
Labeler code
85817
Product ID
85817-008_435c7973-8a68-8f51-e063-6394a90af58f
Type
HUMAN OTC DRUG
Nonproprietary name
Nail Repair Pen
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangzhou Qiexiran Cosmetics Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-12
Substance
UNDECYLENIC ACID
Active strength
20 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
AlphaTip Nail Repair Pen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID20 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
1437295Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
435c7973-8a67-8f51-e063-6394a90af58fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85817-008-01AlphaTip Nail Repair Pen3 mL in 1 TUBE, WITH APPLICATORLIQUID31
85817-008-01AlphaTip Nail Repair Pen2 in 1 BOXLIQUID21

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 27 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Myco Nail A Antifungal SolutionUNDECYLENIC ACIDKramer Novis550358d7-69e8-4ea3-bcf9-d647c457287d2025-12-04WarningsExact identifier
application number: M005
Tea Tree Oil Antifungal SoapsTOLNAFTATENanjing Jitaxing Technology Co., LTD4517d3a7-9144-b91d-e063-6294a90a49902025-12-03WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions23ca78c0-16a9-455c-99a7-b9a9a3affa602025-12-03WarningsExact identifier
application number: M005
Gembooxt Nail Fungus SolutionGEMBOOXT NAIL FUNGUS SOLUTIONGuangdong Quadrant Ecological Technology Co., Ltd.44f5c1bc-decf-beef-e063-6394a90ab5622025-12-02WarningsExact identifier
application number: M005
WELMATE Clotrimazole Topical SolutionCLOTRIMAZOLEYYBA CORPdc5bac4a-938c-4678-89ac-a899440c6a3c2025-12-02WarningsExact identifier
application number: M005
Tolnaftate Cream 1% ANTIFUNGALTOLNAFTATECARDINAL HEALTH 110 dba LEADERbb14825c-518d-bfba-e053-2995a90a78892025-12-02WarningsExact identifier
application number: M005
ProCure AntifungalMICONAZOLE NITRATE 2%Twin Med LLC3d375325-ddad-f1e1-e063-6394a90a679f2025-12-01WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc0a6cb1f7-a2a2-46a2-ae63-d205318996f02025-12-01WarningsExact identifier
application number: M005
CAREALL Miconazole NitrateMICONAZOLE NITRATENew World Imports, Incbed775be-8bcb-44c2-9b9f-8bb25b4b24532025-12-01WarningsExact identifier
application number: M005
CAREALL TolnaftateTOLNAFTATENew World Imports, Inccabf84c1-1500-46fe-b226-b16d4a0666c72025-12-01WarningsExact identifier
application number: M005
TrimazoleCLOTRIMAZOLETrifluent Pharma LLCa3bafc52-1404-4e0b-84c1-e28bffcb091e2025-12-01WarningsExact identifier
application number: M005
APUREE Pure Nailtific Extra-Strength Fungal Nail PatchesAPUREE PURE NAILTIFIC EXTRA-STRENGTH FUNGAL NAIL PATCHESGuangzhou Meixi Biotechnology Co., Ltd.445354d8-bec2-0fd9-e063-6394a90a00992025-11-24WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEVALU MERCHANDISERS, COf4abb499-6893-9efb-e053-2995a90a33ed2025-11-24WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE ATHLETES FOOT POWDER SPRAY TALC FREEVALU MERCHANDISERS, CO9ac97d4a-169b-49ff-aa34-ccb5b43726a12025-11-24WarningsExact identifier
application number: M005
TolnafateFOOT ODOR CONTROL POWDER SPRAYVALU MERCHANDISERS, CO51b69b0f-d63f-4fe0-87e6-722f955687612025-11-24WarningsExact identifier
application number: M005
Miconazole Nitrate Antifungal PowderMICONAZOLE NITRATE ANTIFUNGAL POWDERMarlex Pharmaceuticals, Inc.de4f703c-39e9-855e-e053-2a95a90a6ea92025-11-21WarningsExact identifier
application number: M005
Odor-Eaters Athletes FootTOLNAFTATEBlistex Inc.20d795d1-2345-4d4f-8439-07ad11ff8f652025-11-21WarningsExact identifier
application number: M005
Derman AntifungalZINC UNDECYLENATECompania Internacional de Comercio, S.A.P.I de C.V.0129d801-90f6-49fd-857f-27d6ba9fc66c2025-11-19WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions9afb964c-9b88-4701-adcf-7070e25cb6c12025-11-19WarningsExact identifier
application number: M005
AU KAH CHUEN ANTIFUNGALCLOTRIMAZOLEANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.3a262bcd-e6c0-4554-ab1c-9c861f90e1902025-11-18WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437295undecylenic acid 20 % Topical SolutionPSN435c7973-8a67-8f51-e063-6394a90af58f1
1437295undecylenic acid 200 MG/ML Topical SolutionSCD435c7973-8a67-8f51-e063-6394a90af58f1
1437295undecylenic acid 20 % Topical SolutionSY435c7973-8a67-8f51-e063-6394a90af58f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85817-008-01858170008012 TUBE, WITH APPLICATOR in 1 BOX (85817-008-01) / 3 mL in 1 TUBE, WITH APPLICATOR2025-11-12NoNoCurrent