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 FDA2026-10-12
excluded packagepackage70947-02570947-025-15IInactivated by FDA2026-10-12

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 19 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProClearz Maximum Strength Fungal Shield Brush-on AntifungalTOLNAFTATERooftop Consumer Health, Inc.4d451e87-c25b-49cf-92b8-747b053930c22026-03-02WarningsExact identifier
application number: M005
HAND SANITIZER lsland CoconutALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf3a822-27d2-efef-e063-6294a90a05022026-03-01WarningsExact identifier
application number: M005
HAND SANITIZER Cherry BlossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf48a93-345d-b901-e063-6394a90ab41b2026-03-01WarningsExact identifier
application number: M005
HAND SANITIZER Cucumber MelonALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf552a4-b8b3-6fe3-e063-6394a90a722a2026-03-01WarningsExact identifier
application number: M005
HAND SANITIZER Watermelon SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf57b6e-c271-b4c6-e063-6394a90a63c62026-03-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLETRIFECTA PHARMACEUTICALS USA LLCe0a2a907-9c3a-4c4e-e053-2995a90abb912026-03-01WarningsExact identifier
application number: M005
FOLUPIA FUNGAL NAIL RENEWALFOLUPIA FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4bcacd53-9446-67ec-e063-6294a90a209e2026-02-27WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.d6f5c6b5-5e56-462f-8c47-7986ce53669d2026-02-25WarningsExact identifier
application number: M005
Lakeim FUNGAL NAIL RENEWAL KitFUNGAL NAIL RENEWAL KITGuangzhou Jingliang Cosmetics Co., Ltd.4b6aae50-b219-beee-e063-6394a90ab4152026-02-22WarningsExact identifier
application number: M005
Hermon Jock Itch spray.MICONAZOLE NITRATE 2%Beautivity LLC4b633528-667a-f34e-e063-6294a90a2b3d2026-02-21WarningsExact identifier
application number: M005
Lakeim Fungal Nail Repair PenFUNGAL NAIL REPAIR PENGuangzhou Jingliang Cosmetics Co., Ltd.4b23c3a6-51da-7875-e063-6394a90a14672026-02-18WarningsExact identifier
application number: M005
OSIMOON FUNGAL NAIL RENEWALFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.4b113f31-1a82-a3ca-e063-6394a90a32312026-02-17WarningsExact identifier
application number: M005
Hermon Ringworm Antifungal soap.CLOTRIMAZOLE 1%Beautivity LLC48405a7c-14cd-b3a0-e063-6394a90a9fc92026-02-13WarningsExact identifier
application number: M005
RoyceDerm Tea Tree Oil Antifungal soap.TEA TREE OIL ANTIFUNGAL SOAPRoyceDerm LLC3a6d1e32-a38b-3dde-e063-6394a90a88f32026-02-13WarningsExact identifier
application number: M005
Happy Nuts Jock Itch PowderMICONAZOLE NITRATESuit Up Brands LLC42e2d9df-6537-b3a1-e063-6394a90a47b72026-02-13WarningsExact identifier
application number: M005
Nail Antifungal TreatmentTOLNAFTATE 1% FUNGI NAILBENM INC.2ea24785-c648-4104-e063-6294a90ab12f2026-02-12WarningsExact identifier
application number: M005
Hermon Ringworm Treatment KitMICONAZOLE NITRATE 2% AND CLOTRIMAZOLE 1%Beautivity LLC4a9d9c6e-0e0f-d539-e063-6294a90acb572026-02-12WarningsExact identifier
application number: M005
PHARMBANNER Antifungal Soothing CreamANTIFUNGAL SOOTHING CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3a077685-4177-bc0d-e063-6294a90a461b2026-02-12WarningsExact identifier
application number: M005
PHARMBANNER FUNGAL NAIL RENEWALFUNGAL NAIL RENEWALShenzhen Xinxin Yunhai Technology Co., Ltd.3a08ec6c-03ae-b9e5-e063-6394a90a0afb2026-02-12WarningsExact identifier
application number: M005
PHARMBANNER Tinea Versicolor CreamTINEA VERSICOLOR CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3a095194-c7ea-7f30-e063-6294a90a7ea12026-02-12WarningsExact 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