ANTIFUNGAL PEN UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE 1 g/100mL; 25 g/100mL Liquid — NDC 87571-0001-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ANTIFUNGAL PEN UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE 1 g/100mL; 25 g/100mL Liquid — NDC 87571-001-02 (Billing 87571-0001-02)

by Hanyang Qisheng (Shenzhen) Technology Co., Ltd. · 6 BOTTLE in 1 PACKAGE / 5 mL in 1 BOTTLE

This is a package of ANTIFUNGAL PEN UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE 1 g/100mL; 25 g/100mL Liquid from Hanyang Qisheng (Shenzhen) Technology Co., Ltd., marketed since Apr 2026 and currently FDA-listed.

NDC 87571-0001-02
🏷️ FDA NDC (as labeled) 87571-001-02 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle Pack sizes2 compare ↓
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 87571-001-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87571 labeler · 001 product · 02 package
Package marketed since
Apr 3, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8757100102 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87571-001-02
Product NDC 87571-001
11-digit billing NDC 87571000102
RxCUI 2740011
UNII 012C11ZU6G, K3D86KJ24N
Application # M005
SPL Set ID 4e85f338-ffd7-85b1-e063-6294a90a3c87
Established class (EPC) Allylamine Antifungal
Chemical class Allylamine
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-03
Route TOPICAL
Dosage form LIQUID
Substance TERBINAFINE HYDROCHLORIDE; UNDECYLENIC ACID
Quick answers
  • RxCUI (RxNorm): 2740011
Why two NDCs? The FDA registers this code as 87571-001-02 — 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 → 87571-0001-02. 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 an over-the-counter topical liquid product containing terbinafine hydrochloride and undecylenic acid. Both active ingredients are commonly used in antifungal products applied to the skin. Terbinafine is typically used to help treat fungal infections, while undecylenic acid is commonly used as an antifungal and antiyeast ingredient in topical preparations. This product is marketed under the FDA's over-the-counter monograph rules for antifungal drugs.

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.
Try another pack size: 3 bottles
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
87571-0001-01 87571-001-01 Main listing 3 BOTTLE in 1 PACKAGE / 5 mL in 1 BOTTLE 2026-04-03 — Active
87571-0001-02 You're viewing this 6 BOTTLE in 1 PACKAGE / 5 mL in 1 BOTTLE 2026-04-03 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 6 bottle in 1 package / 5 ml in 1 bottle.
What NDC number is used to bill for this package of ANTIFUNGAL PEN UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE 1 g/100mL; 25 g/100mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Antifungal Pen 1 g/100mL; 25 g/100mLthis 87571-0001-02 Hanyang 6 bottles — — 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
Apr 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 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • 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.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.

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

The official label also statesETHYLHEXYL PALMITATE SQUALANE CAPRYLIC/CAPRIC TRIGLYCERIDE BISABOLOL TOCOPHEROL TEA TREE OIL

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

LabelerHanyang Qisheng (Shenzhen) Technology Co., Ltd.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code87571
First marketedApr 2026
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.

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 10 words ▾

For the effective treatment of nail fungus,discoloration, thickening,splitting,crumbling and brittleness.

⏱️ Dosage and Administration 60 words ▾

Use twice a day for 4 weeks. For initial use, soak the affected nail in warm water to soften it. Gentlyf ile thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results f ile nails every 2-3 days. Rotate clockwise, after the solution f lows out,apply the solution to the affected area.

⚠️ Warnings 3 words ▾

For externaluse only.

🧪 Active Ingredient 6 words ▾

TERBINAFINE HYDROCHLORIDE 1% UNDECYLENIC ACID 25%

🧪 Inactive Ingredients 10 words ▾

ETHYLHEXYL PALMITATE SQUALANE CAPRYLIC/CAPRIC TRIGLYCERIDE BISABOLOL TOCOPHEROL TEA TREE OIL

🎯 Purpose 1 words ▾

Antifungal

📄 Do Not Use 13 words ▾

Do not use children under 2years of age unless directed by a doctor.

📄 When Using This Product 9 words ▾

When using this product avoid contact with the eyes.

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if irritation occurs,discontinue use and consulta doctor.

📄 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 1 words ▾

label

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

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 ANTIFUNGAL PEN (this brand).

Top reported reactions

Treatment Failure3
Intentional Dose Omission2
Nausea2
Vision Blurred2
Abdominal Discomfort1
Abdominal Pain Upper1
Alopecia1

Age at onset

Adult1
Elderly1

Reporter sex

21 reports
Male · 48%
Female · 52%

Serious outcomes

Hospitalization6
Life-threatening1
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.

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 Hanyang Qisheng (Shenzhen) Technology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 3 bottles (87571-0001-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Hanyang Qisheng (Shenzhen) 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.
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.