FDA.reportPublic FDA data

FUNGAL NAIL TREATMENT

Product NDC
76986-031
11-digit product format
769860031
Labeler code
76986
Product ID
76986-031_4ce3f0e2-b533-b89f-e063-6294a90a7e25
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangdong Quadrant Ecological Technology Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-13
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 TREATMENT
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
4ce3f0e2-b532-b89f-e063-6294a90a7e25Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76986-031-01FUNGAL NAIL TREATMENT30 mL in 1 BOTTLELIQUID301

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 11 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEChain Drug Marketing Association327095bd-a7c9-291d-e063-6394a90afafa2026-06-09WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYChain Drug Marketing Association34b5c11f-710f-60e4-e063-6394a90a990d2026-06-09WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYChain Drug Marketing Association342affe8-0a4d-6fe6-e063-6394a90a8dad2026-06-09WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEChain Drug Marketing Associationedc2da26-ae46-4175-86ed-83e1a65f6d142026-06-09WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYChain Drug Marketing Associationaa97d2ca-bcf4-3ee1-e053-2a95a90a748d2026-06-09WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYChain Drug Marketing Association1bd8e096-1717-4656-b52c-086d2f56f0702026-06-09WarningsExact identifier
application number: M005
BODYKOO JOCK ITCH CreamCLOTRIMAZOLE1% JOCK ITCH CREAMJiangxi Yudexi Pharmaceutical Co., LTD53553b31-81bb-d293-e063-6294a90aa0a52026-06-09WarningsExact identifier
application number: M005
BODYKOO ATHLETE FOOT CreamMICONAZOLE NITRATE2% ATHLETE FOOT CREAMJiangxi Yudexi Pharmaceutical Co., LTD53561903-54fe-f8ec-e063-6294a90a19fe2026-06-09WarningsExact identifier
application number: M005
Clotrimazole CreamCLOTRIMAZOLE USP1%Aldermed Inc.53bdd76b-6290-f1d3-e063-6394a90a9ff12026-06-08WarningsExact identifier
application number: M005
Miconazole CreamMICONAZOLE NITRATEAldermed Inc.4a7fc48a-c103-dc84-e063-6394a90ab80f2026-06-08WarningsExact identifier
application number: M005
Antifungal PowderMICONAZOLE NITRATEAldermed Inc.60954089-5220-4f4c-8595-b5ee4562562c2026-06-08WarningsExact identifier
application number: M005
Jock Itch PowderMICONAZOLE NITRATEWalgreens Company06d2f36c-8615-af08-e063-6394a90aa4242026-06-05WarningsExact identifier
application number: M005
Miconazole Nitrate 2%JOCK ITCH SPRAYWalgreens Companycf6cbaf4-beba-6fdf-e053-2995a90a76d22026-06-04WarningsExact identifier
application number: M005
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD5368b131-7537-8679-e063-6394a90a67542026-06-04WarningsExact identifier
application number: M005
Nail Fungus Treatment PenUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe842e1-b3db-c003-e063-6394a90a46b82026-06-04WarningsExact identifier
application number: M005
Lasolex ACMICONAZOLE NITRATE 2% ANTIFUNGALPureTek Corporation52bb4bc1-e88f-f5ea-e063-6394a90ae1e82026-06-03WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.13a14d3c-bfce-42b5-8463-4ec69e94774e2026-06-03WarningsExact identifier
application number: M005
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd43cbad59-9899-ab3b-e063-6294a90a9e122026-06-02WarningsExact identifier
application number: M005
Athletes Foot CreamCLOTRIMAZOLEShenzhen Miandou Technology Co.,Ltd.53451e74-719e-9499-e063-6394a90a9e5a2026-06-02WarningsExact identifier
application number: M005
Lasolex ALMICONAZOLE NITRATE 2% ANTIFUNGALPureTek Corporation534df9be-b47a-03a1-e063-6394a90a265a2026-06-02WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN4ce3f0e2-b532-b89f-e063-6294a90a7e251
998329undecylenic acid 250 MG/ML Topical SolutionSCD4ce3f0e2-b532-b89f-e063-6294a90a7e251
998329undecylenic acid 25 % Topical SolutionSY4ce3f0e2-b532-b89f-e063-6294a90a7e251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76986-031-017698600310130 mL in 1 BOTTLE (76986-031-01) 30 ml2026-03-13NoNoCurrent