FDA.reportPublic FDA data

Undecylenic Acid

Product NDC
70947-025
11-digit product format
709470025
Labeler code
70947
Product ID
70947-025_eff70205-270d-be0c-e053-2a95a90a5b9c
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Worldwide Cosmetics, Inc
Application
M005
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-10-01
Marketing end
0000-00-00
Substance
UNDECYLENIC ACID
Active strength
25 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70947-025IInactivated by FDA2026-10-15
excluded packagepackage70947-02570947-025-15IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70947-025-152022-06-28C16284748780-19d75b9d0-6ddb-f424-e053-dadaa90a57ce70947-025-15
70947-025-152020-01-31C16284748780-19d75b9d0-6ddb-f424-e053-dadaa90a57ce70947-025-15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70947-025-15ETERNAL SPIRIT BEAUTY FUNGI FRESH15 mL in 1 BOTTLE, WITH APPLICATORLIQUID155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70947-025ETERNAL SPIRIT BEAUTY FUNGI FRESH (UNDECYLENIC ACID) LIQUID [WORLDWIDE COSMETICS, INC]5Legacy NDC, 1 package rows20231206_3cf281eb-616e-4a17-e054-00144ff88e88.zip

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 25 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Antifungal Maximum StrengthUNDECYLENIC ACIDTOPCO ASSOCIATES LLC7c44fb4e-0eef-4ced-b03f-a02ebe6c02642025-12-22WarningsExact identifier
application number: M005
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriesa3ae043b-dc97-449b-b099-70bdf8e924822025-12-19WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLERUGBY LABORATORIES6de9155b-7070-38fd-e053-2a91aa0af6f62025-12-19WarningsExact identifier
application number: M005
HC Max Anti-FungalTOLNAFTATEKramer Laboratoriesee99cd87-549f-4a43-878e-b4d5935de0e02025-12-19WarningsExact identifier
application number: M005
Fungi Nail Anti-Fungal PenTOLNAFTATEKramer Laboratories1a0a3b14-d8f2-4363-b3c9-f5028e8eada32025-12-19WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL POWDER SPRAYWinco Foods, LLCcc257a18-247f-c787-e053-2a95a90a075a2025-12-16WarningsExact identifier
application number: M005
TolnaftateODOR CONTROL POWDER SPRAYWalgreen Companya113f568-bd20-4f02-8e09-1b8223a0a9fa2025-12-16WarningsExact identifier
application number: M005
Tobcharm Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.45f92be2-0677-5989-e063-6394a90af2802025-12-15WarningsExact identifier
application number: M005
TEA TREE Oil ANTIFUNGAL CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD45bd3ad0-a0d1-314f-e063-6394a90a9a3a2025-12-12WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREETopco Associates LLC97334166-1dff-4ed2-ad31-f524b22097f92025-12-12WarningsExact identifier
application number: M005
Foot Odor Control PowderTOLNAFTATEMeijer Distribution Inc03fd2680-0040-aa8c-e063-6294a90a090f2025-12-12WarningsExact identifier
application number: M005
Foot Odor Control PowderTOLNAFTATEPremier Brands of America Inc.edb0a2da-aaa1-3b9b-e053-2995a90a50122025-12-12WarningsExact identifier
application number: M005
PedikleerTOLNAFTATERising Pharma Holdings, Inc.83396c51-7107-4d98-9d80-ebf6584f4dc82025-12-11WarningsExact identifier
application number: M005
ELAIMEI FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.457d08eb-e812-8f12-e063-6294a90ab85f2025-12-10WarningsExact identifier
application number: M005
Lofuanna FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.43da9ec2-5f2f-dfce-e063-6394a90aecca2025-12-10WarningsExact identifier
application number: M005
WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25%UNDECYLENIC ACID 25%Shenzhen Shandian Jingling Technology Co., Ltd.457f819b-0850-a97c-e063-6394a90ac3682025-12-09WarningsExact identifier
application number: M005
NAIL REPAIR PENUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd45814b84-0e51-6c9d-e063-6394a90a29052025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAYBetter Living Brandsccfef81b-f271-4551-e053-2a95a90a8ac42025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREEFoodhold USAa64c9371-0ac7-4c47-bc12-7bc77162b2442025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEHarris Teeter, LLC02eb9c78-5a89-4958-b5a4-68f39e584cf22025-12-09WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN3cf281eb-616e-4a17-e054-00144ff88e885
998329undecylenic acid 250 MG/ML Topical SolutionSCD3cf281eb-616e-4a17-e054-00144ff88e885
998329undecylenic acid 25 % Topical SolutionSY3cf281eb-616e-4a17-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70947-025-157094700251515 mL in 1 BOTTLE, WITH APPLICATOR (70947-025-15) 15 ml2016-10-010000-00-00NoNoCurrent