FDA.reportPublic FDA data

NAIL REPAIR PEN

Product NDC
84763-008
11-digit product format
847630008
Labeler code
84763
Product ID
84763-008_45814b84-0e52-6c9d-e063-6394a90a2905
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Yunqi Cosmetics (Shenzhen) Co., Ltd
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-09
Substance
UNDECYLENIC ACID
Active strength
.25 g/mL
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
NAIL REPAIR PEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID.25 g/mL

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
45814b84-0e51-6c9d-e063-6394a90a2905Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84763-008-01NAIL REPAIR PEN24 mL in 1 TUBE, WITH APPLICATORLIQUID241
84763-008-01NAIL REPAIR PEN8 in 1 BOXLIQUID81
84763-008-02NAIL REPAIR PEN12 mL in 1 TUBE, WITH APPLICATORLIQUID121
84763-008-02NAIL REPAIR PEN4 in 1 BOXLIQUID41

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 17 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Velloryn ANTIFUNGAL CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4e38e1f1-0466-5b91-e063-6294a90a66c42026-03-30WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength Daytime AntigungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGALGuangzhou Meixi Biotechnology Co., Ltd.4e3d226b-57f1-75a6-e063-6394a90a96cd2026-03-30WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength Nighttime AntifungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGALGuangzhou Meixi Biotechnology Co., Ltd.4e3e8895-34b4-de69-e063-6294a90a55322026-03-30Exact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREECVS Pharmacy3380263d-ee7b-4946-a467-35a24789a9012026-03-27WarningsExact identifier
application number: M005
Micro-Guard (AF)MICONAZOLE NITRATEColoplast Corpa43a94d0-fec0-470f-bdb4-535dcce6d1e02026-03-27WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Fresh CitrusLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d77ec6-a1d1-13dc-e063-6394a90a95f42026-03-26WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Deeply CleanLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d83736-66da-abb9-e063-6294a90a3d672026-03-26WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Sea Minerals and Aloe VeraLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d8848c-d157-6e2c-e063-6294a90aa2592026-03-26WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock ItchANTIFUNGAL TREATMENT KITBeautivity LLC4800a93b-7042-827b-e063-6294a90acd952026-03-25WarningsExact identifier
application number: M005
Toenail Fungus TreatmentTERBINAFINEShenzhen Wankelai E-commerce Co., Ltd.4dc1d7f7-e4ae-c54b-e063-6394a90aa4202026-03-24WarningsExact identifier
application number: M005
Lasolex Liquid SolutionCLOTRIMAZOLE 1%PureTek Corporation4dc9e64d-8235-b218-e063-6394a90a01572026-03-24WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment .Soap. BarTOLNAFTATE 1%Beautivity LLC4dbbf09b-5bc1-501b-e063-6394a90a2a9d2026-03-23WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4dbc521c-2f5f-9736-e063-6294a90ad85d2026-03-23WarningsExact identifier
application number: M005
seebeellar clotrimazole 1% antifungal creamSEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd4d80e551-76c2-150a-e063-6394a90a79962026-03-20WarningsExact identifier
application number: M005
Nail Fungal PenUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.4d5b5c22-4781-6391-e063-6294a90a70102026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MADRID MUSEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5cecf6-c232-6cd9-e063-6394a90a03e92026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER VALENCIA VIBESALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5de4d6-4c58-f393-e063-6294a90a323a2026-03-19WarningsExact identifier
application number: M005
Toenail Fungus PenUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.4d5e256f-7fd5-f903-e063-6394a90a11602026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MALLORCA BREEZEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5e50de-62fd-f9e9-e063-6394a90af0bd2026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MAR BELLAALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d6005d9-5d4d-033e-e063-6294a90ad36f2026-03-19WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN45814b84-0e51-6c9d-e063-6394a90a29051
998329undecylenic acid 250 MG/ML Topical SolutionSCD45814b84-0e51-6c9d-e063-6394a90a29051
998329undecylenic acid 25 % Topical SolutionSY45814b84-0e51-6c9d-e063-6394a90a29051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84763-008-01847630008018 TUBE, WITH APPLICATOR in 1 BOX (84763-008-01) / 24 mL in 1 TUBE, WITH APPLICATOR2025-12-09NoNoCurrent
84763-008-02847630008024 TUBE, WITH APPLICATOR in 1 BOX (84763-008-02) / 12 mL in 1 TUBE, WITH APPLICATOR2025-12-09NoNoCurrent