FDA.reportPublic FDA data

Fungal Nail Repair Pen

Product NDC
84763-011
11-digit product format
847630011
Labeler code
84763
Product ID
84763-011_523c32f7-b804-bf79-e063-6394a90aad5a
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
2026-05-20
Substance
UNDECYLENIC ACID
Active strength
.25 g/mL
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
Fungal Nail Repair Pen
Listing expiration
2027-12-31

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
523c32f7-b803-bf79-e063-6394a90aad5aAvailable 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
84763-011-01Fungal Nail Repair Pen15 mL in 1 BOTTLE, DROPPERLIQUID151
84763-011-01Fungal Nail Repair Pen5 in 1 BOXLIQUID51

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 39 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATECardinal Health 110 dba LEADER34f4c733-2eb2-0db0-e063-6394a90a64312025-05-13WarningsExact identifier
application number: M005
Dr CANUSO fungal nail eraserTOLNAFTATE OILRenu Laboratories, LLC2083f9ed-09d6-26e6-e054-00144ff88e882025-05-13WarningsExact identifier
application number: M005
Dr. Canuso foot repair serumTOLNAFTATE SERUMRenu Laboratories, LLC1fcc52c5-7030-13cb-e054-00144ff8d46c2025-05-13WarningsExact identifier
application number: M005
Private Label Antifungal Barrier CreamMICONAZOLE NITRATE ANTIFUNGAL CREAMSwiss-American CDMO, LLC2ee40c37-504b-43ed-960a-5350154074922025-05-09WarningsExact identifier
application number: M005
Osimoon Fungal Nail Treatment KitOSIMOON FUNGAL NAIL TREATMENT KITGuangzhou Zanming Trading Co., Ltd.34aec10d-a0d0-d956-e063-6394a90a39b22025-05-09WarningsExact identifier
application number: M005
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC33d9c724-d4c4-2597-e063-6294a90aa5f32025-04-28WarningsExact identifier
application number: M005
ANTIFUNGALCLOTRIMAZOLEVIVE HEALTH LLC33db98f5-f6d9-742a-e063-6394a90a2a032025-04-28WarningsExact identifier
application number: M005
Foot Cure Nail Repair PenANTIFUNGAL NAIL REPAIR PENSANSAR, LLC9c823e27-8bb3-4ccd-bf7e-a99d45908e882025-04-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER CUCUMBER MELONALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3380404d-9499-e9fb-e063-6394a90a0f272025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER SWEET GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3380fe6d-e059-401a-e063-6394a90a787a2025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3381cefb-281c-9b85-e063-6294a90acfd92025-04-24WarningsExact identifier
application number: M005
Wish Hand Sanitizer Coconut Cream White FloralsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA33826aef-6e50-2730-e063-6394a90a727b2025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER GOLDEN CITRUSALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3391a78e-525d-c2ba-e063-6394a90a1e992025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA33927939-a9dc-ab67-e063-6394a90a71cc2025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT. SUPER HOME PRODUCT INDONESIA336c751f-6a33-ca55-e063-6394a90a97492025-04-23WarningsExact identifier
application number: M005
WISH HAND SANITIZER VIOLET ORCHID SANDALWOODALCOHOL HAND SANITIZERPT. SUPER HOME PRODUCT INDONESIA337e4526-238a-bc2d-e063-6394a90a5a272025-04-23WarningsExact identifier
application number: M005
ELLEN HAND SANITIZER2ETHYL ALCOHOLPT. SUPER HOME PRODUCT INDONESIA334574b6-6d4a-bd37-e063-6394a90a67d62025-04-21WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEGERI-GENTLE CORPORATIONe6734616-c16b-430c-e053-2a95a90a18f82025-04-21WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLEGERI-GENTLE CORPORATIONe673748f-d00b-4ce8-e053-2995a90a92202025-04-21WarningsExact identifier
application number: M005
PHYTOZINE RINGWORM TREATMENT MAXIMUM STRENGTHTOLNAFTATEThe Sisquoc Healthcare Corporation5dff6ee7-f7a9-4841-8357-6b0801d253f12025-04-21WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN523c32f7-b803-bf79-e063-6394a90aad5a1
998329undecylenic acid 250 MG/ML Topical SolutionSCD523c32f7-b803-bf79-e063-6394a90aad5a1
998329undecylenic acid 25 % Topical SolutionSY523c32f7-b803-bf79-e063-6394a90aad5a1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN523c32f7-b803-bf79-e063-6394a90aad5a1
998329undecylenic acid 250 MG/ML Topical SolutionSCD523c32f7-b803-bf79-e063-6394a90aad5a1
998329undecylenic acid 25 % Topical SolutionSY523c32f7-b803-bf79-e063-6394a90aad5a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84763-011-01847630011015 BOTTLE, DROPPER in 1 BOX (84763-011-01) / 15 mL in 1 BOTTLE, DROPPER2026-05-20NoNoCurrent