FDA.reportPublic FDA data

ELON Dual Defense Anti Fungal Formula

Product NDC
71171-778
11-digit product format
711710778
Labeler code
71171
Product ID
71171-778_2cc52b1d-28d2-6315-e063-6294a90a46c0
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID
Dosage form
LIQUID
Route
TOPICAL
Labeler
Little Giant Holdings LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-02
Substance
UNDECYLENIC ACID
Active strength
250 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71171-778-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71171-778-150efc9e666f02…f202fb6c5f17…

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
ELON Dual Defense Anti Fungal Formula
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
998329Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
45c4567d-7876-6459-e054-00144ff88e88Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71171-778-15ELON Dual Defense Anti Fungal Formula15 mL in 1 BOTTLELIQUID153
71171-778-15ELON Dual Defense Anti Fungal Formula1 in 1 BOXLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71171-778ELON DUAL DEFENSE ANTI FUNGAL FORMULA (UNDECYLENIC ACID) LIQUID [LITTLE GIANT HOLDINGS LLC]3Current NDC, Legacy NDC, 2 package rows20250130_45c4567d-7876-6459-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 12 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Athletes FootMICONAZOLE NITRATEPremier Brands of America Inc52d0909a-f404-0af4-e063-6394a90a3d0c2026-06-01WarningsExact identifier
application number: M005
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd431483f6-2386-9f5c-e063-6294a90af1042026-06-01WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWalgreens Company3f8d45e1-54a2-a658-e063-6294a90a6cbb2026-06-01WarningsExact identifier
application number: M005
Remedy NailsUNDECYLENIC ACIDAdwill Labs Inc4e87b76c-c430-466a-bc30-fe1785c7c6602026-06-01WarningsExact identifier
application number: M005
Anytalk Nail Fungus Treatment 15ml (1% Tonailate)TOLNAFTATE1%Guangzhou Huixue Biotechnology Co., Ltd.52f1f654-fba3-e90e-e063-6394a90a1df42026-05-29WarningsExact identifier
application number: M005
RoyceDerm Tea Tree Oil Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC52da8be4-467c-c011-e063-6294a90a166f2026-05-28WarningsExact identifier
application number: M005
Terramed Just Think Comfort Jock Itch Antifungal TreatmentMICONAZOLE NITRATERida LLC2acb9027-8f20-4b77-9b45-17fe11622c7c2026-05-27WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL TEA TREETOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd52b3b0df-3f62-f9bc-e063-6394a90a52b32026-05-26WarningsExact identifier
application number: M005
ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b51877-e04c-569e-e063-6394a90a2fc92026-05-26WarningsExact identifier
application number: M005
NAIL EXTRA STRENGTH REPAIR PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6208d-53e4-eaa0-e063-6394a90abe7a2026-05-26WarningsExact identifier
application number: M005
Toenail Fungus Pen PreventativeUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6766f-948b-2602-e063-6294a90a03cf2026-05-26WarningsExact identifier
application number: M005
KDMANTOLNAFTATEDongguan Youmi Trading Co., Ltd52a4e836-2059-a49f-e063-6394a90a65562026-05-25WarningsExact identifier
application number: M005
PUTRIZENUNDECYLENIC ACID, TOLNAFTATEGuangzhou Lianbiquan Biological Technology co., Ltd52a58f24-2a11-4d34-e063-6394a90a29242026-05-25WarningsExact identifier
application number: M005
Eye CareSprayEYELID CLEANSING SPRAYShenzhen Shierjie Biological Engineering Co., LTD52aef5dd-ff33-cace-e063-6294a90a415a2026-05-25WarningsExact identifier
application number: M005
Saviland PRO Extra Strength Toenail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD5250003a-8d3a-818b-e063-6294a90aa6592026-05-21WarningsExact identifier
application number: M005
Saviland SSPro X Series Extra Strength Toenail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52506297-44d7-b2a7-e063-6394a90a0a3c2026-05-21WarningsExact identifier
application number: M005
SSPROTIP X Extra Strength Nail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52512e7e-5e28-4383-e063-6294a90a448a2026-05-21WarningsExact identifier
application number: M005
Vrenmol Extra Strength Nail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52516861-e386-d0cb-e063-6394a90a17d02026-05-21WarningsExact identifier
application number: M005
SSPROTIP X Extra Strength Toenail Renewal SolutionTOLNAFTATE,UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52519110-a3c9-21da-e063-6294a90abbce2026-05-21WarningsExact identifier
application number: M005
Fungal Nail Repair PenUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd523c32f7-b803-bf79-e063-6394a90aad5a2026-05-20WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN45c4567d-7876-6459-e054-00144ff88e883
998329undecylenic acid 250 MG/ML Topical SolutionSCD45c4567d-7876-6459-e054-00144ff88e883
998329undecylenic acid 25 % Topical SolutionSY45c4567d-7876-6459-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71171-778-15711710778151 BOTTLE in 1 BOX (71171-778-15) / 15 mL in 1 BOTTLE1 bottle2017-01-020000-00-00NoNoCurrent