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 15 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEWal-Mart Stores, Incaf4d4e9e-8678-3a80-e053-2995a90a677f2026-04-22WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYWal-Mart Stores, Incaf4ebb3b-041e-30dd-e053-2995a90a8d2d2026-04-22WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYWal-Mart Stores, Incaf4dd045-ca51-42b9-e053-2a95a90a03272026-04-22WarningsExact identifier
application number: M005
4ozMICONAZOLENabrace LLC4f912a20-e0f7-23c1-e063-6294a90a55d62026-04-18WarningsExact identifier
application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete FeetNABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEETNabrace LLC4fc3ddc8-08a2-ae50-e063-6294a90a1e072026-04-18WarningsExact identifier
application number: M005
SimplyVital Antifungal ClotrimazoleCLOTRIMAZOLEAlpha Plants Inc44881106-3ab4-4103-9c48-1da435ab5b132026-04-16WarningsExact identifier
application number: M005
medicatedMICONAZOLENabrace LLC4f90d8ad-33d9-0043-e063-6394a90a44662026-04-16WarningsExact identifier
application number: M005
Ingrown Nail TreatmentJALAWEF INGROWN NAIL TREATMENTConsilii LLC1ac2d7fc-1806-7925-e063-6294a90ad3b52026-04-15WarningsExact identifier
application number: M005
RDVHDLW Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDShenzhen Joyuflsh Technology Co.,Ltd.4f68796c-11e1-e5f7-e063-6394a90adeb12026-04-14WarningsExact identifier
application number: M005
ProBliva Psoriasis Scalp .spray.SALICYLIC ACID 3%CAVTECH HOLDING LLC4f695604-51c5-c1b7-e063-6294a90ab5ae2026-04-14WarningsExact identifier
application number: M005
OSIMOON Fungal Nail TreatmentFUNGAL NAIL TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.4f7817db-cd71-fba9-e063-6294a90a9cdf2026-04-14WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL PERSIMMONTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f520058-3b81-574e-e063-6294a90a2eae2026-04-13WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL CHARCOALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f538041-e2f1-4a5f-e063-6294a90a54cf2026-04-13WarningsExact identifier
application number: M005
RoyceDerm tinea ANTIFUNGAL .cream. and .soap.CREAM AND SOAPRoyceDerm LLC4f4ef2d0-98fa-e791-e063-6394a90a70452026-04-12WarningsExact identifier
application number: M005
Nailtific Daytime Treatment Antifungal Pen RefillNAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILLGuangzhou Meixi Biotechnology Co., Ltd.4257ee32-0d8f-08d4-e063-6294a90a4a892026-04-11WarningsExact identifier
application number: M005
Nailtific Nighttime Antifungal Renewal Pen RefillTOLNAFTATEGuangzhou Meixi Biotechnology Co., Ltd.42634fc7-d0c7-4813-e063-6294a90a702d2026-04-11WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEChain Drug Marketing Association Inc1a4f4d10-6782-ddb4-e063-6294a90ac2062026-04-09WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eed68e6-6814-0181-e063-6394a90a888e2026-04-08WarningsExact identifier
application number: M005
TAGOQHIA Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDGuangzhou Borderless Technology Co., Ltd.4eefbef4-7643-dca4-e063-6394a90a72c12026-04-08WarningsExact identifier
application number: M005
ZYNTHIXUNDECYLENIC ACID SOLUTIONShenzhen Siwei Yijiu Trading Co., Ltd.4ef4a167-f673-efb4-e063-6294a90a30262026-04-08WarningsExact 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