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 26 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bee Venom Toenail Fungus TreatmentBEE VENOM TOENAIL FUNGUS TREATMENTShenzhen Earth Surface Trading Co., Ltd.457c705a-9c49-c8c5-e063-6394a90a6aa32025-12-08WarningsExact identifier
application number: M005
Tolnaftate Antifungal PowderTOLNAFTATESCHOLL'S WELLNESS COMPANY LLC2a0e006b-60b1-41b9-a5d2-ff0e34b48ff52025-12-06WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions1e7e74f6-9bca-48ab-804a-a7a81df3b6082025-12-05WarningsExact identifier
application number: M005
Oiangna Tea Tree Oil AntifungalCLOTRIMAZOLE 1%Guangzhou Huixue Biotechnology Co., Ltd.453452a7-c613-6111-e063-6294a90aca812025-12-05WarningsExact identifier
application number: M005
Tinactin AntifungalTOLNAFTATEBayer HealthCare LLC.5f95be36-6efa-4dfb-9a40-88f4ce1de2b32025-12-05WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.c3b715a9-233a-401a-ba60-f78c1ddf1ded2025-12-05WarningsExact identifier
application number: M005
LotriminCLOTRIMAZOLEBayer HealthCare LLC.b584e17f-ed43-43bd-b643-dfa48edd78c62025-12-05WarningsExact identifier
application number: M005
Fungicure Night CreamCLOTRIMAZOLEKobayashi Healthcare International, Inc.43029403-2afd-cfa1-e063-6394a90a99a32025-12-04WarningsExact identifier
application number: M005
Lotrimin Daily Prevention DeoTOLNAFTATEBayer HealthCare LLC.9e8bfb78-ad81-93d0-e053-2995a90aa41d2025-12-04WarningsExact identifier
application number: M005
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer Healthcare LLC.0c53cf0f-767e-a422-e063-6394a90ab7642025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.0a80a5b0-3216-46f6-8801-7066ef59aee42025-12-04WarningsExact identifier
application number: M005
Lotrimin AntifungalCLOTRIMAZOLEBayer HealthCare LLC.f9536683-3f32-4c71-9b6a-70f8611e3dcf2025-12-04WarningsExact identifier
application number: M005
Lotrimin AF DeodorantMICONAZOLE NITRATEBayer HealthCare LLC.0bee54eb-df2f-15fe-e063-6294a90a2fd22025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.0beda157-efd2-5245-e063-6394a90a69112025-12-04WarningsExact identifier
application number: M005
Lotrimin AFMICONAZOLE NITRATEBayer Healthcare LLC.163996c6-af54-21ac-e063-6394a90ac05c2025-12-04WarningsExact identifier
application number: M005
Lotrimin Daily Prevent DeodorantTOLNAFTATEBayer HealthCare LLC.1bb961cd-b6e6-3aff-e063-6394a90a432e2025-12-04WarningsExact identifier
application number: M005
Tinactin DeodorantTOLNAFTATEBayer HealthCare LLC.1751d576-e94a-d7d1-e063-6294a90a03ff2025-12-04WarningsExact identifier
application number: M005
Tinactin Jock ItchTOLNAFTATEBayer HealthCare LLC163ab4df-6e4a-6239-e063-6294a90a1cd02025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLCbb878f31-2189-4427-aacf-5bce96d759782025-12-04WarningsExact identifier
application number: M005
LotriminCLOTRIMAZOLEBayer HealthCare LLCda948ef3-3709-4bfc-9d17-f6f1ea3253432025-12-04WarningsExact 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