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Kimtara Nail Fungus Treatment 1 g/100mL; 25 g/100mL Liquid, 3 mL — NDC 84558-0023-01 package photo

Kimtara Nail Fungus Treatment 1 g/100mL; 25 g/100mL Liquid, 3 mL

by GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd · 3 mL in 1 BOX (84558-023-01)
NDC 84558-0023-01
🏷️ FDA NDC (as labeled) 84558-023-01 billing pads the product segment with a zero
This package
Contains3 mL Pack sizes2 compare ↓
Also comes in: 30 ml 84558-0023-02
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) 84558-023-01
Product NDC 84558-023
11-digit billing NDC 84558002301
RxCUI 2747127
UNII G7RIW8S0XP, K3D86KJ24N
Application # M005
SPL Set ID 5678e260-10c4-f203-e063-6294a90a6223
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 2026-07-13
Route TOPICAL
Dosage form LIQUID
Substance TERBINAFINE; UNDECYLENIC ACID
Why two NDCs? The FDA registers this code as 84558-023-01 — 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 → 84558-0023-01. 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 YUSONG FINE CHEMICLS Co., Ltd
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code84558
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio25 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?

Kimtara Nail Fungus Treatment is a topical liquid containing terbinafine and undecylenic acid. Terbinafine is an antifungal that works by disrupting fungal cell membranes, while undecylenic acid is a fatty acid commonly used in over-the-counter antifungal products. This OTC monograph product is applied directly to affected nails and surrounding skin and is typically used to address fungal nail infections. Both ingredients are included in FDA's established rule-book for over-the-counter antifungal treatments.

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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 331KBJ17RK
    Canola oil is a plant-based oil derived from rapeseed. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and may improve how the body absorbs certain medications.
  • 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 ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • 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 AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 6Y8XYV2NOF
    A waxy substance made by honeybees from plant resins and pollen. In medicines, it acts as a binder and coating agent to hold ingredients together and protect the product.
  • UNII 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • 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 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.

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

The official label also statesAloe Barbadensis Leaf Extract, Canola Oil,Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Leptospermum Scoparium Branch/LeafOil,Origanum Vulgare Oil, Mentha Piperita (Peppermint) Oil, Propolis Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Melaleuca Alternifolia(Tea Tree) Leaf Oil, Tocopherol

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.
Try another pack size: 30 ml
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
Kimtara Nail Fungus Treatment 1 g/100mL; 25 g/100mLthis 84558-0023-01 GUANGZHOU 3 ml — — 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
Jul 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
84558-0023-01 You're viewing this 3 mL in 1 BOX (84558-023-01) 2026-07-13 Active
84558-0023-02 30 mL in 1 BOX (84558-023-02) 2026-07-13 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 84558-0023-01?
NDC 84558-0023-01 contains 3 mL — 3 ml in 1 box.
What is the difference between NDC 84558-0023-01 and NDC 84558-0023-02?
Both are Kimtara Nail Fungus Treatment 1 g/100mL; 25 g/100mL Liquid — the drug itself is identical. NDC 84558-0023-01 is the 3 mL package, while NDC 84558-0023-02 is the 30 ml package.
What NDC number is used to bill for this package of Kimtara Nail Fungus Treatment 1 g/100mL; 25 g/100mL Liquid?
Bill NDC 84558-0023-01 — the 11-digit billing format is 84558002301. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 84558-023-01, 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: 84558-0023-01, written without dashes as 84558002301. 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 84558-0023-01, the first segment (84558) is the labeler code FDA assigned to GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd; the middle segment (0023) 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 YUSONG FINE CHEMICLS 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 30 ml (84558-0023-02). 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?
GUANGZHOU YUSONG FINE CHEMICLS 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 15 words ▾

Use Treats athlete's foot, ringworm, and jock itch. Helps improve the appearance of fungus-affected nails.

⏱️ Dosage and Administration 63 words ▾

Directions FIRST USE: Twist the top of the pen several times to prime. Wait 1-2 minutes for the solution to reach the brush tip. DAILY USE: File the affected nail surface gently. Twist the top of the pen a few times to release the solution. Apply evenly to the nail surface and edges. Allow to dry completely. Use twice daily for best results.

⚠️ Warnings 5 words ▾

Warnings For external use only.

📦 Storage and Handling 10 words ▾

Other information Store at room temperature. Keep cap tightly closed.

🧪 Active Ingredient 7 words ▾

Active Ingredient(s) Undecylenic Acid 25% Terbinafine 1%

🧪 Inactive Ingredients 44 words ▾

Inactive ingredients Aloe Barbadensis Leaf Extract, Canola Oil,Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Leptospermum Scoparium Branch/LeafOil,Origanum Vulgare Oil, Mentha Piperita (Peppermint) Oil, Propolis Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Melaleuca Alternifolia(Tea Tree) Leaf Oil, Tocopherol

🎯 Purpose 2 words ▾

Purpose Antifungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84558-0022-01 · GUANGZHOU 84558-0024-01 · 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.