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Extra Strength Toenail Renewal Pen Undecylenic Acid, Tolnaftate .25 g/mL; .01 g/mL Liquid, 5 mL — NDC 85966-0012-01 package photo

Extra Strength Toenail Renewal Pen Undecylenic Acid, Tolnaftate .25 g/mL; .01 g/mL Liquid, 5 mL

by GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD · 5 mL in 1 BOTTLE, DROPPER (85966-012-01)
NDC 85966-0012-01
🏷️ FDA NDC (as labeled) 85966-012-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 85966-012-01
Product NDC 85966-012
11-digit billing NDC 85966001201
RxCUI 2691548
UNII K3D86KJ24N, 06KB629TKV
Application # M005
SPL Set ID 4eeb59d2-3891-2e45-e063-6294a90a4fcf
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-08
Route TOPICAL
Dosage form LIQUID
Substance UNDECYLENIC ACID; TOLNAFTATE
Why two NDCs? The FDA registers this code as 85966-012-01 — 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 → 85966-0012-01. 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

LabelerGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85966
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio19 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 a topical liquid product marketed as an over-the-counter monograph drug, applied directly to toenails. It contains tolnaftate and undecylenic acid, two antifungal agents commonly used together in products intended to address fungal nail conditions. Both ingredients are typically found in antifungal treatments designed for topical use on nails and skin.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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.
  • UNII 6SO6U10H04
    Biotin is a B-vitamin used as a nutritional supplement in some medications. It may also serve as a colorant or marker in formulations.
  • UNII 9H4PO4Z4FT
    A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
  • UNII A1A1I8X02B
    A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII 578389D6D0
    Clove oil is an essential oil derived from clove plant buds. It's used in medicines as a flavoring agent and for its mild preservative properties to help maintain product stability.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII M6QU9ZUH2X
    A natural essential oil derived from the Manuka tree, used in medicines as a fragrance, flavor enhancer, and preservative to improve product appeal and shelf stability.
  • 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 7D0CGR40U1
    A natural oil extracted from oregano leaves, used as a flavoring agent and preservative in medicines. It adds taste and may help protect the product from degradation.
  • UNII O414PZ4LPZ
    A beta hydroxy acid derived from willow bark or synthesized chemically. In topical medicines, it acts as a keratolytic agent that helps soften and shed dead skin cells, improving penetration of active ingredients.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • 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 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.

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

The official label also statesUrea Ethoxydiglycol Lactic Acid Dimethyl Sulfone Biotin Melaleuca Ericifolia Leaf Oil Leptospermum Scoparium Branch/Leaf Oil Eucalyptus Globulus Leaf Oil Origanum Vulgare Leaf Oil Eugenia Caryophyllus (Clove) Bud Oil Squalane Simmondsia Chinensis Seed Oil Salicylic Acid Tocopheryl Acetate Ethylhexylglycerin Aqua

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/100mL 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/mLthis 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

🏛️
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85966-0012-01 You're viewing this 5 mL in 1 BOTTLE, DROPPER (85966-012-01) 2026-04-08 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 85966-012-01, 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: 85966-0012-01, written without dashes as 85966001201. 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 85966-0012-01, the first segment (85966) is the labeler code FDA assigned to GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD; the middle segment (0012) 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 GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GUANGZHOU SAWEILAN IMPORT & EXPORT 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.

📄 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 53 words ▾

Helps improve the appearance of nails and supports the renewal of discolored or rough nail surfaces through mechanical and chemical exfoliating action. Proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Relieves itching, scaling, cracking, burning, and discomfort associated with these conditions.

⏱️ Dosage and Administration 160 words ▾

Clean the affected nail and dry thoroughly. File the nail surface to remove thickness Pro Tip: To prevent re-infection, always disinfect the file with 70% rubbing alcohol after each use. Twist the base of the pen clockwise until the liquid flows to the nib.

Apply a thin layer of the product over affected area twice daily (morning and night. Wait 2-3 minutes for the treatment to be fully absorbed. Allow to dry, then apply the affected toe with the waterproof protective film.

For best results, use overnight or before wearing shoes to keep the medication in place. NOTE: For athlete's foot Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and jock itch, use daily for a full 4-week course.

If symptoms persist, consult a doctor. Not intended for use on the scalp or nails. This product is not effective on the scalp or nails.

⚠️ Warnings 14 words ▾

For external use only. Store in a cool place and avoid sunshine and heat.

🧪 Active Ingredient 5 words ▾

Undecylenic Acid 25% Tolnaftate 1%

🧪 Inactive Ingredients 39 words ▾

Urea Ethoxydiglycol Lactic Acid Dimethyl Sulfone Biotin Melaleuca Ericifolia Leaf Oil Leptospermum Scoparium Branch/Leaf Oil Eucalyptus Globulus Leaf Oil Origanum Vulgare Leaf Oil Eugenia Caryophyllus (Clove) Bud Oil Squalane Simmondsia Chinensis Seed Oil Salicylic Acid Tocopheryl Acetate Ethylhexylglycerin Aqua

🎯 Purpose 1 words ▾

Antifungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85966-0011-01 · GUANGZHOU 85966-0013-01 · 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.