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 31 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Antifungal LiquidTOLNAFTATEFSA Store Inc.fae36294-68b6-bf14-e053-6394a90aaacd2025-10-27WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.58dd955e-e68b-4fbd-90c8-a85b15c00dc72025-10-25WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLEVERLIT GLOBAL INC.1360cdd8-b2b2-4af9-b6ff-af1101d49e182025-10-25WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYBetter Living Brands LLCccff8d63-ee7d-eada-e053-2995a90ac5dd2025-10-24WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYBetter Living Brands LLCccff4830-6d81-2a0d-e053-2a95a90a154c2025-10-24WarningsExact identifier
application number: M005
Liquid Antifungal TreatmentTOLNAFTATEHudson Health LLC14a9efd8-e49f-12fa-e063-6394a90aa8a02025-10-24WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEHudson Health LLC36ec5f05-5d1c-25df-e063-6394a90a9dd92025-10-24WarningsExact identifier
application number: M005
Signature Care Antifungal Cream Tolnaftate 1%TOLNAFTATEBETTER LIVING BRANDS LLCb02b81d6-8db4-927b-e053-2995a90a39582025-10-24WarningsExact identifier
application number: M005
Winco Foods TolnaftateTOLNAFTATEWinco Foods, LLC218f7613-1401-4f1b-bf46-576b536825af2025-10-23WarningsExact identifier
application number: M005
zourunan MULTI-PURPOS TREATMENTMULTI-PURPOS TREATMENTGuchutang Biotechnology (Longyan) Co., Ltd41bad254-b674-9521-e063-6294a90ab6342025-10-22WarningsExact identifier
application number: M005
zourunan FOOT ODOR PROBIOTICFOOT ODORGuchutang Biotechnology (Longyan) Co., Ltd41bbc02c-53f2-2d94-e063-6394a90ac9ec2025-10-22WarningsExact identifier
application number: M005
Signature Care Athletes FootCLOTRIMAZOLESafewayc1750c17-4afb-aecf-e053-2a95a90af35b2025-10-22WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATEImperial Feet B.V.1189c7d8-7c8f-ae01-e063-6294a90ac2702025-10-21WarningsExact identifier
application number: M005
Fungicure Liquid GelCLOTRIMAZOLEKobayashi Healthcare International, Inc.dfd03852-29bd-4e16-97f3-64dfde5f8ff82025-10-21WarningsExact identifier
application number: M005
Athlete Foot Medicated barTOLNAFTATEBeautivity LLC3b2cedb2-18f4-f571-e063-6394a90a64182025-10-21WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATEQuantum, Inc.6cb95707-9831-41f1-a23e-9e3356141fdc2025-10-20WarningsExact identifier
application number: M005
Toe FungusTOLNAFTATEImperial Feet B.V.118a6c97-4e8a-050a-e063-6294a90a11082025-10-17WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALTOLNAFTATEGuangzhou Haishi Biological Technology Co., Ltd.4141574d-7a5b-c437-e063-6394a90aacb62025-10-16WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYHY-VEE, INC415ecf9b-460d-82b6-e063-6294a90a0e052025-10-16WarningsExact identifier
application number: M005
SEACALL NAIL REVIVE SERUMNAIL REVIVE SERUMGuangdong Quadrant Ecological Technology Co., Ltd.1f4d0c9a-361e-72e5-e063-6394a90a7cda2025-10-15WarningsExact 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