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FGPER Topical Antifungal Pen UNDECYLENIC ACID 25 g/100mL Liquid — NDC 85593-0126-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

FGPER Topical Antifungal Pen UNDECYLENIC ACID 25 g/100mL Liquid — NDC 85593-126-01 (Billing 85593-0126-01)

by Guangzhou ChuanMa International Trading Co.,Ltd. · 4 APPLICATOR in 1 BOX / 3 mL in 1 APPLICATOR

This is a package of FGPER Topical Antifungal Pen UNDECYLENIC ACID 25 g/100mL Liquid from Guangzhou ChuanMa International Trading Co.,Ltd., marketed since Sep 2026 and currently FDA-listed. It is this product's only package size.

NDC 85593-0126-01
🏷️ FDA NDC (as labeled) 85593-126-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85593-126-01
Product NDC 85593-126
11-digit billing NDC 85593012601
RxCUI 998329
UNII K3D86KJ24N
UPC 0699838984424
Application # M005
SPL Set ID 5abdcbff-6ab1-2f0a-e063-6294a90a57ef
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-05
Route TOPICAL
Dosage form LIQUID
Substance UNDECYLENIC ACID
Quick answers
  • RxCUI (RxNorm): 998329
Why two NDCs? The FDA registers this code as 85593-126-01 — 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 → 85593-0126-01. 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.

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.

Clinical

🧪 What is this product?

This is a topical liquid antifungal product containing undecylenic acid, marketed as an over-the-counter monograph drug. Undecylenic acid is commonly used in antifungal preparations applied to the skin to help address fungal infections. The liquid form allows for application to affected skin areas. This product is regulated under the FDA's established rules for nonprescription antifungal drugs rather than as an individually approved application.

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.

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 mLPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85593-0126-01 You're viewing this Main listing 4 APPLICATOR in 1 BOX / 3 mL in 1 APPLICATOR 2026-09-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Undecylenic Acid 25 g/100mL 49283-0025-05 Chemco 15 ml — — FDA listed —
Terpenicol Antifungal 25 g/100mL 63347-0600-01 Blaine 37.5 ml — — FDA listed —
South Beach Multi-Purpose Nail Repair 25 g/100mL 85214-0025-05 SOUTH 1 bottle — — FDA listed —
Assielf Antifungal Pen 25 g/100mL 87418-0002-01 Shenzhen 3 tubes — — 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 25 g/100mL 49283-0250-05 Chemco 15 ml — — FDA listed —
Venrock 25 g/100mL 85772-0009-01 Guangzhou 1 bottle — — FDA listed —
Foot Choice-Nail Fungal Pen 25 g/100mL 87830-0001-01 Foot 2 applicators — — FDA listed —
Persiancat ANTIFUNGAL PEN 25 g/100mL 85593-0130-01 Guangzhou 3 vials — — FDA listed —
FGPER Topical Antifungal Pen 25 g/100mLthis 85593-0126-01 Guangzhou 4 applicators — — FDA listed —
Pureskin Antifungal Pen 25 g/100mL 87217-0004-01 BENLONG 4 applicators — — FDA listed —
Neomen Antifungal Pen 25 g/100mL 88017-0001-01 Heartland 4 applicators — — 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

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 RV6J6604TK
    Eucalyptol is a natural oil compound extracted from eucalyptus plants. In medicines, it serves as a flavoring agent and aromatic component to improve taste and smell.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.

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

The official label also statesInactive ingredients ISOPROPYL ALCOHOL, ISOPROPYL MYRISTATE, MELALEUCAALTERNIFOLIA (TEA TREE) LEAF OIL, EUCALYPTOL

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.

Manufacturer & labeler

LabelerGuangzhou ChuanMa International Trading Co.,Ltd.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85593
First marketedSep 2026
Product typeHuman Otc Drug
Portfolio37 products on file
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.

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 91 words ▾

Directions ·wash the affected area and dry thoroughlyremove cap, hold brush downward, and twist base slowly until productreaches brushapply a thin layer over affected area twice daily, morning and night, oras directed byadoctor supervise children in the use of this productfor athlete's foot, pay special attention to spaces between the toes;wear well-fiting,ventilated shoes and change shoes and socks at leastonce dailyfor athlete's foot and rinaworm. use daily for 4 weks,for jock itch, usedail for 2 weeksif condition persists longer, consult a doctorthis product is not effective on the scalp or nails

⏱️ Dosage and Administration 29 words ▾

Stop use and aska doctor if irritation occurs; there is noimprovement within 4 weeks for athlete's foot or ringworm;or there is no improvement within 2 weeks for jock itch.

⚠️ Warnings 28 words ▾

WarningsFor external use only. Do not use on children under 2 years of age unless directed by a doctor When using this product avoid contact with the eyes.

🧪 Active Ingredient 5 words ▾

Undecylenic Acid 25%W/W Purpose Antifungal

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients ISOPROPYL ALCOHOL, ISOPROPYL MYRISTATE, MELALEUCAALTERNIFOLIA (TEA TREE) LEAF OIL, EUCALYPTOL

🎯 Purpose 12 words ▾

treats most athlete's foot (tinea pedis),jock itch (tinea cruris), and ringworm(tinea corporis)

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 2 words ▾

package 85593-126-01

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Guangzhou ChuanMa International Trading Co.,Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangzhou ChuanMa International Trading 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.
← 85593-0125-01 · Guangzhou 85593-0127-01 · Guangzhou →
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.