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SFEIXE ANTIFUNGAL PEN UNDECYLENIC ACID 25 g/100mL Paste — NDC 87259-0001-01 package photo

SFEIXE ANTIFUNGAL PEN UNDECYLENIC ACID 25 g/100mL Paste

by Zhejiang JOOZENA Medical Technology Co., Ltd. · 3 TUBE in 1 BOX (87259-001-01) / 6 mL in 1 TUBE
NDC 87259-0001-01
🏷️ FDA NDC (as labeled) 87259-001-01 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 87259-001-01
Product NDC 87259-001
11-digit billing NDC 87259000101
UNII K3D86KJ24N
Application # M002
SPL Set ID 455ad304-86bc-0abe-e063-6294a90a5b43
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-08
Route TOPICAL
Dosage form PASTE
Substance UNDECYLENIC ACID
Why two NDCs? The FDA registers this code as 87259-001-01 — 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 → 87259-0001-01. 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.

🏭 Manufacturer & labeler

LabelerZhejiang JOOZENA Medical Technology Co., Ltd.
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code87259
First marketedDec 2025
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

🧪 What is this product?

This is a topical paste containing undecylenic acid, an over-the-counter monograph drug product. Undecylenic acid is typically used in antifungal products applied to the skin to help address fungal infections. The paste form allows direct application to affected areas. As an OTC monograph product, it is marketed according to established FDA guidelines for this category of antifungal agents.

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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII L13YF113GN
    A plant extract from Euphorbia hirta, a tropical herb. It functions as a natural flavoring agent and may help preserve the medicine by providing antimicrobial properties in the formulation.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII C4ZF6XLD2X
    A synthetic polymer used as a binder and thickening agent in medicines. It helps hold tablet ingredients together and can increase the viscosity of liquid formulations.
  • UNII 49G13A93VE
    A plant extract from the bark of the golden larch tree, used in herbal or botanical formulations for its traditional properties. It may serve as an active botanical ingredient or natural additive in certain supplement or traditional medicine products.
  • UNII YUL4LO94HK
    Resorcinol is a chemical compound used in medicines as an active antimicrobial and keratolytic agent in topical products. It helps reduce bacteria and promotes skin cell shedding in treatments for acne and other skin conditions.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

The official label also stateswater, euphorbia hirta whole, glycerin,hydracrylic acid,pseudolarix amabilis bark, resorcinol,

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 systemPer gPer 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sfeixe Antifungal Pen 25 g/100mLthis 87259-0001-01 Zhejiang 3 tubes — — FDA listed —
Toenail Fungus Treatment 25 g/100mL 85595-0002-01 Guangzhou 2 tubes — — Discontinued —
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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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 SFEIXE ANTIFUNGAL PEN (this brand).

Top reported reactions

Treatment Failure3
Intentional Dose Omission2
Nausea2
Vision Blurred2
Abdominal Discomfort1
Abdominal Pain Upper1
Ankle Fracture1

Reporter sex

20 reports
Male · 50%
Female · 50%

Serious outcomes

Death1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 3 0
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 NDCDescription Marketing startStatus
87259-0001-01 You're viewing this 3 TUBE in 1 BOX (87259-001-01) / 6 mL in 1 TUBE 2025-12-08 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 ✓ Available
Inactive ingredients (structured) ✓ 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 87259-001-01, 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: 87259-0001-01, written without dashes as 87259000101. 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 87259-0001-01, the first segment (87259) is the labeler code FDA assigned to Zhejiang JOOZENA Medical Technology Co., Ltd.; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Zhejiang JOOZENA Medical Technology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Zhejiang JOOZENA Medical Technology Co., Ltd. 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 52 words ▾

This product is not effective for thetreatment of ringworm of the scalp or nails. For athlete's foot:pay special attention to spaces between the toes, wearwell-fitting, ventilated shoes, and change shoes and socks atleast once daily. To prevent athlete's foot, apply once ortwice daily(morning and/or night). Apply to skin around thenail and cuticle.

⏱️ Dosage and Administration 42 words ▾

For athlete's foot and ringworm: use daily for 4 weeks, Cleanthe affected area and dry thoroughly. Apply a thin layer ofthe product over affected area twice daily (morning andnight) or as directed by a doctor. Supervise children in theuse of this product,

⚠️ Warnings 45 words ▾

Warnings For external use only. Do not use on children under 2 years of age unless directedby a doctor. When using this product, avoid contact with eyes.Stop use and ask a doctor if irritation occurs, there is noimprovement within 4 weeks (for athlete's foot andringworm).

🧪 Active Ingredient 3 words ▾

UNDECYLENIC ACID 25%

🧪 Inactive Ingredients 9 words ▾

water, euphorbia hirta whole, glycerin,hydracrylic acid,pseudolarix amabilis bark, resorcinol,

🎯 Purpose 26 words ▾

Cures most Athlete's Foot (Tinea Pedis) and Ringworm(Tinea Corporis). Relieves itching, scaling, cracking, burning,redness, sorenes, and irritation and discomfort.Helpsprevent most athlete's foot (dermatophytosis) with daily use.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 87257-0001-01 · Nanjing 87261-0100-01 · Dermgentle →
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.