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 29 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-Fungal PowderMICONAZOLE NITRATETopCo Associates19c3fbc5-abde-57df-e063-6394a90a125c2025-11-06WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYTopco Associates LLC17993a9f-0d44-43a1-8608-94ee8a08b5392025-11-06WarningsExact identifier
application number: M005
DVO Estriol creamESTRIOL0.2%Guangzhou Huixue Biotechnology Co., Ltd.42e4cc84-7c00-6937-e063-6294a90a0c092025-11-05WarningsExact identifier
application number: M005
MedlineMICONAZOL NITRATEMedline Industries, LPdad58efb-cc20-577a-e053-2a95a90abd9d2025-11-03WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYHEBc6af941a-0b85-4611-a6f3-b13fcf3c4a872025-11-03WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYHEBc585605b-ecb8-4dd8-9205-a9be02d751fa2025-11-03WarningsExact identifier
application number: M005
Premier Solutions Antifungal Tolnaftate LiquidTOLNAFTATEPremier Brands of America, Inc.e1971c1c-5687-577b-e053-2a95a90ad95f2025-11-03WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYPremier Brands of America Inc.3803c643-35d1-06d4-e063-6294a90ac6f62025-11-03WarningsExact identifier
application number: M005
Anti-fungal Powder Miconazole NitrateMICONAZOLE NITRATEMeijer Distribution Inc03fd069d-685d-b8ac-e063-6394a90a31f82025-10-31WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYPremier Brands of America Inc.7a6a63cd-e87d-4229-8acf-b65d63909eb62025-10-31WarningsExact identifier
application number: M005
AzolenMICONAZOLE NITRATEStratus Pharmaceuticals, Inc.9c2574f3-3be4-405a-9c87-943dc6ef87772025-10-30WarningsExact identifier
application number: M005
Family Care AntifungalCLOTRIMAZOLEUnited Exchange Corp.63255079-ecf1-1e77-e053-2a91aa0a7b6c2025-10-30WarningsExact identifier
application number: M005
Miconazorb AFMICONAZOLE NITRATEAmerisourceBergen Drug Corporation13a20d21-42d5-fe56-e063-6394a90aaf572025-10-30WarningsExact identifier
application number: M005
Antifungal Liquid ContinuousMICONAZOLE NITRATEFamily Dollar Services, Inc17cc4601-f946-df8b-e063-6394a90a38972025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYARMY & AIR FORCE EXCHANGE SERVICE932b1be8-3dbb-49ae-822a-c44a24fbe36a2025-10-30WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYGEISS, DESTIN AND DUNN, INC.c367c2e8-5423-bf01-e053-2a95a90ab8e92025-10-30WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYHarris Teeter, LLC636b0d6f-4e36-4c96-9e71-7bfdebb7f3cb2025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYHarris Teeter, LLCf140e9bb-507b-4048-8b7b-8cc51b6a497d2025-10-30WarningsExact identifier
application number: M005
HEB Athlete Foot AntifungalMICONAZOLE NITRATEHEB2e204111-b5d3-0220-e063-6294a90a67bb2025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL SPRAY LIQUIDKroger Co.0cfebac3-684d-4599-b75f-9a82708db7172025-10-30WarningsExact 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