FDA.reportPublic FDA data

ETADERM Advanced Antifungal Support

Product NDC
84180-471
11-digit product format
841800471
Labeler code
84180
Product ID
84180-471_13874210-91df-0642-e063-6294a90a7c12
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
NUEPHASE LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-25
Substance
UNDECYLENIC ACID
Active strength
250 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
ETADERM Advanced Antifungal Support
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID250 mg/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
2677799Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
adb12a1c-ece9-4a59-a62c-89d212c57e6fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84180-471-00ETADERM Advanced Antifungal Support29 mL in 1 JARCREAM291

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84180-471ETADERM ADVANCED ANTIFUNGAL SUPPORT (UNDECYLENIC ACID) CREAM [NUEPHASE LLC]1Current NDC, 1 package rows20240325_adb12a1c-ece9-4a59-a62c-89d212c57e6f.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 49 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltd14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltdb82cea56-b09f-411d-a6cf-c53b3ce0e3b62023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd78131b57-1ffc-4eb8-821e-f7bb73300fe92023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdeb30e5de-9074-4760-8e92-e1d1c127227d2023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltdbe85ec5b-eb49-4f1a-a87d-5c9705a20f232023-10-22WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.579c1ab5-50b4-4b5a-a189-c1e2827d0c3a2023-10-14WarningsExact identifier
application number: M005
Micomitin AntifungalCLOTRIMAZOLEPureTek Corporationdd05f5f9-2412-1295-e053-2995a90acb962022-02-14WarningsExact identifier
application number: M005
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2677799undecylenic acid 25 % Topical CreamPSNadb12a1c-ece9-4a59-a62c-89d212c57e6f1
2677799undecylenic acid 250 MG/ML Topical CreamSCDadb12a1c-ece9-4a59-a62c-89d212c57e6f1
2677799undecylenic acid 25 % Topical CreamSYadb12a1c-ece9-4a59-a62c-89d212c57e6f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84180-471-008418004710029 mL in 1 JAR (84180-471-00) 29 ml2024-03-25NoNoCurrent