ELON Dual Defense Anti Fungal Formula UNDECYLENIC ACID 250 mg/mL Liquid
by Little Giant Holdings LLC · 1 BOTTLE in 1 BOX (71171-778-15) / 15 mL in 1 BOTTLE
NDC 71171-0778-15
🏷️ FDA NDC (as labeled)
71171-778-15
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Undecylenic Acid (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0697-2026
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0694-2026
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0695-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
71171-778-15
Product NDC
71171-778
11-digit billing NDC
71171077815
RxCUI
998329
UNII
K3D86KJ24N
Application #
M005
SPL Set ID
45c4567d-7876-6459-e054-00144ff88e88
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2017-01-02
Route
TOPICAL
Dosage form
LIQUID
Substance
UNDECYLENIC ACID
Why two NDCs?
The FDA registers this code as 71171-778-15 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71171-0778-15. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Other antifungals for topical use class.
Drug family (ATC)
Other antifungals for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerLittle Giant Holdings LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code71171
First marketedJan 2017
Product typeHuman Otc Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
📗 Our plain-language guide HelloPharmacist
- It treats three common fungal skin infections: athlete's foot (the itchy, scaly condition that affects the feet and toes), jock itch (a fungal rash in the groin area), and ringworm...
- What exactly does undecylenic acid treat?
- For athlete's foot and ringworm, most products are used daily for 4 full weeks. For jock itch, 2 weeks of daily use is typically recommended. Some nail products note that visible i...
- That depends on the product. Most undecylenic acid creams, sprays, and general topical solutions are not effective on nails and should not be used there. However, some products — l...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Undecylenic Acid — tap one for details:
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about UNDECYLENIC ACID?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Undecylenic Acid 25 g/100mL 49283-0025-05 | Chemco | 15 ml | — | — | FDA listed | — |
| Antifungal 25 g/100mL 49283-0250-05 | Chemco | 15 ml | — | — | FDA listed | — |
| Myco Nail A Antifungal Solution 250 mg/mL 52083-0242-30 | Kramer | 1 bottle | — | — | FDA listed | — |
| Hongo Killer 25 mg/100mL 58593-0826-01 | Efficient | 30 ml | — | — | FDA listed | — |
| Terpenicol Antifungal 25 g/100mL 63347-0600-01 | Blaine | 37.5 ml | — | — | FDA listed | — |
| Premier Value Antifungal Maximum Strength 25 mg/30mL 68016-0474-00 | PHARMACY | 30 ml | — | — | FDA listed | — |
| ELON Dual Defense Anti Fungal Formula 250 mg/mLthis 71171-0778-15 | Little | 1 bottle | — | — | FDA listed | — |
| Human Science Antifungal Foot Care 250 mg/mL 71356-0156-01 | HUMAN | 30 ml | — | — | FDA listed | — |
| Tripenicol S .25 g/mL 73352-0550-01 | Trifluent | 37.5 ml | — | — | FDA listed | — |
| Bldaxn Nail Repair Pen .25 g/mL 76986-0022-01 | Guangdong | 3 bottles | — | — | FDA listed | — |
| Nerante Fungus Nail Pen .25 g/mL 76986-0030-01 | Guangdong | 6 tubes | — | — | FDA listed | — |
| Fungal Nail Treatment .25 g/mL 76986-0031-01 | Guangdong | 30 ml | — | — | FDA listed | — |
| FLUSH Maximum Strength Antifungal formula 250 mg/mL 80569-0084-15 | Triple | 15 ml | — | — | FDA listed | — |
| Antifungal Treatment Liquid 25 undeclylenic Acid 250 mg/mL 83691-0000-00 | SANSAR, | 1 bottle | — | — | FDA listed | — |
| Foot Cure Nail Repair Pen 25 g/100mL 83691-0011-01 | SANSAR, | 4 applicators | — | — | FDA listed | — |
| Omzok Antifungal Pen 25 g/100mL 83804-0007-01 | Shenzhen | 5 applicators | — | — | FDA listed | — |
| WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25% .25 g/mL 83804-0012-01 | Shenzhen | 5 tubes | — | — | FDA listed | — |
| Pharmbanner Fungal Nail Renewal 25 g/100mL 83818-0019-01 | Shenzhen | 2 bottles | — | — | FDA listed | — |
| MEOLY Fungal Nail Renewal 25 g/100mL 83818-0026-01 | Shenzhen | 2 bottles | — | — | FDA listed | — |
| Fungal Nail Renewal 25 g/100mL 84007-0130-01 | Medhome | 30 ml | — | — | Discontinued | — |
| Klipp EXTRA STRENGTH TOENAIL FUNGUS TREATMENT 25 g/100mL 84558-0018-01 | GUANGZHOU | 30 ml | — | — | FDA listed | — |
| Klipp Fungal Nail Treatment 25 g/100mL 84558-0019-01 | GUANGZHOU | 30 ml | — | — | FDA listed | — |
| Nail Repair Pen .25 g/mL 84763-0008-01 | Yunqi | 8 tubes | — | — | FDA listed | — |
| Antifungal Toenail Fungus Pen .25 g/mL 84763-0009-01 | Yunqi | 12 ml | — | — | FDA listed | — |
| Fungal Nail Repair Pen .25 g/mL 84763-0011-01 | Yunqi | 5 bottles | — | — | FDA listed | — |
| Antifungal Pen 25 g/100mL 84896-0008-01 | Guangzhou | 15 ml | — | — | FDA listed | — |
| Nail Extra Strength Repair Pen 25 g/100mL 84896-0009-01 | Guangzhou | 12 ml | — | — | FDA listed | — |
| Antifungal Pen 25 g/100mL 85210-0001-01 | XF | 1 applicator | — | — | FDA listed | — |
| South Beach Multi-Purpose Nail Repair 25 g/100mL 85214-0025-05 | SOUTH | 1 bottle | — | — | FDA listed | — |
| Bldaxn FUNGAL NAIL RENEWZL 25 g/100mL 85248-0029-01 | Jiangxi | 2 bottles | — | — | FDA listed | — |
| Puvida Fungal Nail Renewal 25 g/100mL 85248-0090-01 | Jiangxi | 30 ml | — | — | FDA listed | — |
| ViLLsure Antifungal Pen 25 g/100mL 85248-0151-01 | Jiangxi | 5 tubes | — | — | FDA listed | — |
| Serynth Antifungal Nail Treatment Pen 25 g/100mL 85248-0165-01 | Jiangxi | 2.5 ml | — | — | FDA listed | — |
| LYSSERA Fungal Nail Renewal 25 g/100mL 85248-0174-01 | Jiangxi | 4 tubes | — | — | FDA listed | — |
| Werpeka Fungal Nail Renewal 25 g/100mL 85248-0184-01 | Jiangxi | 2.5 ml | — | — | FDA listed | — |
| Toyknier Multi-Purpose Treatment 25 g/100mL 85248-0187-01 | Jiangxi | 30 ml | — | — | FDA listed | — |
| Minadcin Toenail Fungus Pen 25 g/100mL 85248-0199-01 | Jiangxi | 5 tubes | — | — | FDA listed | — |
| Beukow Antifungal Pen 25 g/100mL 85248-0200-01 | Jiangxi | 4 tubes | — | — | FDA listed | — |
| Kakalsa TOENAIL FUNGUS TREATMENT 25 g/100mL 85248-0204-01 | Jiangxi | 4 tubes | — | — | FDA listed | — |
| Avenaster Fungal Nail Care Duo Set (Night) 25 g/100mL 85248-0214-01 | Jiangxi | 3 tubes | — | — | FDA listed | — |
| TrpWinner TOENAIL FUNGUS PEN 25 g/100mL 85248-0218-01 | Jiangxi | 4 ml | — | — | FDA listed | — |
| Cyyzrose Antifungal Nail 25 g/100mL 85248-0222-01 | Jiangxi | 3 tubes | — | — | FDA listed | — |
| Bodykoo Nail Fungus Treatment 25 g/100mL 85248-0227-01 | Jiangxi | 15 ml | — | — | FDA listed | — |
| Sovs Fungal Nail Repair Renewal 25 g/100mL 85248-0232-01 | Jiangxi | 30 ml | — | — | FDA listed | — |
| Fungal Nail Treatment 25 g/100mL 85308-0002-01 | Gaoye | 30 ml | — | — | Discontinued | — |
| Fungal Nail Treatment 25 g/100mL 85308-0003-01 | Gaoye | 30 ml | — | — | Discontinued | — |
| Toenail Fungus Treatment 25 g/100mL 85569-0005-01 | 100 | 30 ml | — | — | FDA listed | — |
| Tegasolve Toenail Fungus Treatment 25 g/100mL 85578-0003-01 | Zhengzhou | 1 bottle | — | — | FDA listed | — |
| OetMoe Antifungal Solution 250 mg/mL 85636-0007-01 | Shenzhen | 20 ml | — | — | FDA listed | — |
| Bee Venom Toenail Fungus Treatment 250 mg/mL 85636-0008-01 | Shenzhen | 20 ml | — | — | FDA listed | — |
| Bee Venom Toenail Fungus Treatment 250 mg/mL 85636-0011-01 | Shenzhen | 20 ml | — | — | FDA listed | — |
| Tobcharm Fungus Nail Renewal 25 g/100mL 85817-0005-01 | Guangzhou | 2 bottles | — | — | FDA listed | — |
| Arflom Toenail Fungus Treatment Liquid 25 g/100mL 85817-0006-01 | Guangzhou | 2 bottles | — | — | FDA listed | — |
| VTROUY Fungus Nail Renewal 25 g/100mL 85817-0007-01 | Guangzhou | 2 bottles | — | — | FDA listed | — |
| FUNGLARA Anti Fungal 250 mg/mL 87028-0876-00 | FUNGLARA | 15 ml | — | — | FDA listed | — |
| Nail Fungal Pen 25 g/100g 87298-0015-01 | Guangzhou | 3 g | — | — | FDA listed | — |
| Toenail Fungus Pen 25 g/100g 87298-0016-01 | Guangzhou | 3 g | — | — | FDA listed | — |
| CuraNails Antifungal Pen 25 g/100mL 87300-0001-01 | Quality | 3 applicators | — | — | FDA listed | — |
| Lakeim Fungal Nail Repair Pen 25 g/100mL 87408-0007-01 | Guangzhou | 3 tubes | — | — | FDA listed | — |
| Lakeim FUNGAL NAIL RENEWAL Kit 25 g/100mL 87408-0009-01 | Guangzhou | 2 bottles | — | — | FDA listed | — |
| OSIMOON Fungal Nail Treatment 25 g/100mL 87408-0014-01 | Guangzhou | 2 bottles | — | — | FDA listed | — |
| Uauko Fungal Nail Treatment 25 g/100mL 87408-0018-01 | Guangzhou | 2 bottles | — | — | FDA listed | — |
| VTROUY Fungal Nail Renewal Pen 25 g/100mL 87408-0023-01 | Guangzhou | 3 tubes | — | — | FDA listed | — |
| YEARCHOICE Fungal Nail Repair Pen 25 g/100mL 87408-0024-01 | Guangzhou | 3 tubes | — | — | FDA listed | — |
| Assielf Antifungal Pen 25 g/100mL 87418-0002-01 | Shenzhen | 3 tubes | — | — | FDA listed | — |
| Zynthix 1 g/4mL 87575-4041-01 | Shenzhen | 3 applicators | — | — | FDA listed | — |
| Totclear Nail Renewal 250 mg/mL 87725-0004-01 | GOOD | 20 ml | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2017
On the market since
Jan 2017
📍
2026
Currently FDA-listed
9 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ELON Dual Defense Anti Fungal Formula (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 50%
Female · 50%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71171-0778-15 You're viewing this | 1 BOTTLE in 1 BOX (71171-778-15) / 15 mL in 1 BOTTLE | 2017-01-02 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71171-778-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71171-0778-15, written without dashes as 71171077815. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71171-0778-15, the first segment (71171) is the labeler code FDA assigned to Little Giant Holdings LLC; the middle segment (0778) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Little Giant Holdings LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Little Giant Holdings LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses Proven clinically effective in the treatment of most athletes's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). Helps prevent most athlete's foot with daily use. For effective relief of: Itching Burning Cracking
⏱️ Dosage and Administration ▾
Directions Wash affected area well, and let product sit for 1-2 minutes before rinsing. Make sure to dry affected area thoroughly. Supervise children in the use of this product For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at leat once daily Use 1-2 times daily.
Use daily for 4 weeks; if condition persists longer, ask a doctor This product is not effective on the scalp or nails
⚠️ Warnings ▾
Warnings For external use only. Do not use on children under 2 years of age except under the supervision of a doctor. When using this product avoid contact with the eyes. Stop use and ask a doctor if: Irritation occurs There is no improvement within 4 weeks Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Active ingredients: Undecylenic Acid 25.0% Purpose Antifungal
🧪 Inactive Ingredients ▾
Inactive ingredients: Aqua (Deionized Water), Calendula Officianalis Extract, Citrus Grandis (Grapefruit) Seed Extract, Ethyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil.
🎯 Purpose ▾
Purpose Antifungal
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.