Home › NDC Lookup › Ingredients › Tolnaftate, Undecylenic Acid › 85038-0001-01
Toenail Fungus Treatment Extra Strength Pen TOLNAFTATE, UNDECYLENIC ACID 1 g/100mL; 25 g/100mL Liquid — NDC 85038-0001-01 package photo

Toenail Fungus Treatment Extra Strength Pen TOLNAFTATE, UNDECYLENIC ACID 1 g/100mL; 25 g/100mL Liquid

by Lianjiang Shanlilai E-commerce Co., Ltd. · 3 BOTTLE in 1 PACKAGE (85038-001-01) / 5 mL in 1 BOTTLE
NDC 85038-0001-01
🏷️ FDA NDC (as labeled) 85038-001-01 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

🆔 Identity & classification

FDA NDC (as labeled) 85038-001-01
Product NDC 85038-001
11-digit billing NDC 85038000101
RxCUI 2691548
UNII 06KB629TKV, K3D86KJ24N
Application # M005
SPL Set ID 28fbcc50-a3ac-d6d1-e063-6294a90aa2b6
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-11
Route TOPICAL
Dosage form LIQUID
Substance TOLNAFTATE; UNDECYLENIC ACID
Why two NDCs? The FDA registers this code as 85038-001-01 — 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 → 85038-0001-01. 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.

🏷️ 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

LabelerLianjiang Shanlilai E-commerce Co., Ltd.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85038
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio6 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.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter monograph topical liquid product for toenail fungus. It contains two active ingredients, tolnaftate and undecylenic acid, both of which are typically used to help treat fungal infections of the toenails and feet. Tolnaftate and undecylenic acid work by targeting fungal growth and are commonly included together in antifungal formulations. The product is applied directly to the affected nail area.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • 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.
  • 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.

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

The official label also statesALCOHOL DIMETHICONE CETOSTEARYL ALCOHOL TEA TREE OIL PROPYLENE GLYCOL TOCOPHEROL SAFFLOWER OIL WATER

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bldaxn Fungus Nail Pen .01 g/mL; .25 g/mL 76986-0026-01 Guangdong 4 bottles — — FDA listed —
RDVHDLW Extra Strength NAIL REPAIR PEN .25 g/mL; .01 g/mL 83766-0001-01 Shenzhen 5 bottles — — FDA listed —
DRAWZONE Toenail Fungus Treatment Pen 25 g/100mL; 1 g/100mL 83766-0107-01 Shenzhen 6 bottles — — FDA listed —
ERWCNMIE Toenail Fungus Treatment Pen 1 g/100mL; 25 g/100mL 83766-0108-01 Shenzhen 3 bottles — — FDA listed —
Nailtific Daytime Treatment Antifungal Pen Refill 1.5 g/6mL; .06 g/6mL 84167-0012-27 Guangzhou 1 bottle — — FDA listed —
APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen 25 g/1; 1 g 84167-0364-02 Guangzhou 2 bottles — — FDA listed —
APUREE Nailtific Extra-Max Strength Daytime Antigungal 1 g/1; 25 g 84167-0423-01 Guangzhou 1 vial — — FDA listed —
APUREE Nailtific Extra-Max Strength Antigungal .25 g/1; .01 g 84167-0662-23 Guangzhou 5 bottles — — FDA listed —
Toenail Fungus Treatment Extra Strength Pen 1 g/100mL; 25 g/100mLthis 85038-0001-01 Lianjiang 3 bottles — — FDA listed —
TOENAIL FUNGUS TREATMENT Liquid 25 g/100mL; 1 g/100mL 85038-0002-01 Lianjiang 1 bottle — — FDA listed —
Yamangu Fungal Nail Repair Pen 25 g/100mL; 1 g/100mL 85248-0196-01 Jiangxi 6 tubes — — FDA listed —
Htrcsw Fungal Nail Renewal 25 g/100mL; 1 g/100mL 85248-0217-01 Jiangxi 3 tubes — — FDA listed —
cmojsk TOENAIL FUNGUS PEN 1 g/100mL; 25 g/100mL 85248-0220-01 Jiangxi 4 tubes — — FDA listed —
Fitcube NAIL REPAIR PEN 25 g/100mL; 1 g/100mL 85248-0230-01 Jiangxi 4 tubes — — FDA listed —
TAGOQHIA Extra Strength NAIL REPAIR PEN 25 g/100mL; 1 g/100mL 85304-0031-01 Guangzhou 3 bottles — — FDA listed —
Extra Strength Nail Fungus Treatment 1 g/100mL; 25 g/100mL 85966-0001-01 GUANGZHOU 30 ml — — FDA listed —
Nail Fungus Treatment Pen 25 g/100mL; 1 g/100mL 85966-0005-01 GUANGZHOU 3 bottles — — FDA listed —
Extra Strength Toenaiil Renewal Pen .01 g/mL; .25 g/mL 85966-0010-01 GUANGZHOU 5 ml — — FDA listed —
EXTRA STRENGTH TOENAIIL RENEWAL Solution .25 g/mL; .01 g/mL 85966-0011-01 GUANGZHOU 1 bottle — — FDA listed —
Extra Strength Toenail Renewal Pen .25 g/mL; .01 g/mL 85966-0012-01 GUANGZHOU 5 ml — — FDA listed —
Extra Strength Toenail Renewal Solution .25 g/mL; .01 g/mL 85966-0013-01 GUANGZHOU 30 ml — — FDA listed —
SSPROTIP X Extra Strength Toenail Renewal Solution .01 g/mL; .25 g/mL 85966-0017-01 GUANGZHOU 1 bottle — — FDA listed —
ONIADBA Fungal Nail Treatment Swabs 1 g/100mL; 25 g/100mL 85992-0002-01 Shenzhen 23 ml — — FDA listed —
WCTNGO Fungal Nail Treatment Swabs 1 g/100mL; 25 g/100mL 85992-0003-01 Shenzhen 23 ml — — FDA listed —
ONIADBA Nail Fungus Treatment Pen 1 g/100mL; 25 g/100mL 85992-0004-01 Shenzhen 4 tubes — — FDA listed —
Putrizen 1 g/4g; .04 g/4g 87724-5118-01 Guangzhou 5 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85038-0001-01 You're viewing this 3 BOTTLE in 1 PACKAGE (85038-001-01) / 5 mL in 1 BOTTLE 2024-12-11 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 85038-001-01, 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: 85038-0001-01, written without dashes as 85038000101. 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 85038-0001-01, the first segment (85038) is the labeler code FDA assigned to Lianjiang Shanlilai E-commerce 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 Lianjiang Shanlilai E-commerce Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lianjiang Shanlilai E-commerce 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 9 words ▾

For the effective treatment of nail fungus,discoloration,thick-ening,splitting,crumbling and brittleness.

⏱️ Dosage and Administration 65 words ▾

Wash and dry your nails before use, Remove the capcovering the brush of the pen. Twist the end of the pen clockwise to dispense the liquidonto the brush. Apply the liquid 3 times over the areas that need to berepalred, and make sure to cover all affected parts. Use 2-3 times daily for 2-4 week s, depending on thecondition of the area that needs repair.

⚠️ Warnings 4 words ▾

For external use only.

📦 Storage and Handling 15 words ▾

Store between 15° to 30 °C (59 °to 86 °F)Avoid freezing andexcessive heat above 40C°(104F).

🧪 Active Ingredient 5 words ▾

TOLNAFTATE 1% UNDECYLENIC ACID 25%

🧪 Inactive Ingredients 13 words ▾

ALCOHOL DIMETHICONE CETOSTEARYL ALCOHOL TEA TREE OIL PROPYLENE GLYCOL TOCOPHEROL SAFFLOWER OIL WATER

🎯 Purpose 1 words ▾

Anti-fungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85037-0002-02 · Olive 85038-0002-01 · Lianjiang →
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.