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antifungal pen 1 g/100U Liquid, 2-count — NDC 84558-0022-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

antifungal pen 1 g/100U Liquid, 2-count — NDC 84558-022-01 (Billing 84558-0022-01)

by GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd · 2 U in 1 BOX

This is a package of 2 us of antifungal pen 1 g/100U Liquid from GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd, marketed since Jun 2026 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 84558-0022-01
🏷️ FDA NDC (as labeled) 84558-022-01 billing pads the product segment with a zero
This package
Contains2-count Pack sizes3 compare ↓
Main listing for product 84558-022 · Also comes in: 1 u 84558-022-03 3 us 84558-022-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 30, 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

NDC database record

One package, one record: these facts belong to NDC 84558-022-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84558 labeler · 022 product · 01 package
Package marketed since
Jun 24, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8455802201 2
FDA record last changed
Jul 30, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84558-022-01
Product NDC 84558-022
11-digit billing NDC 84558002201
UNII 06KB629TKV
Application # M005
SPL Set ID 5756256e-ed2b-4e13-e063-6294a90a1e0f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-24
Route TOPICAL
Dosage form LIQUID
Substance TOLNAFTATE
Why two NDCs? The FDA registers this code as 84558-022-01 — 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 → 84558-0022-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It treats fungal skin infections like athlete's foot, ringworm and, in some products, jock itch. Many products also help prevent athlete's foot. Some are made for skin around the n...
  • Wash and dry the area well, then apply a thin layer. Most products are used twice a day, morning and night. The length of use varies, often 4 weeks for athlete's foot and ringworm,...
  • The main one is skin irritation. If that happens, stop using it and talk to a doctor.
  • Call if you see no improvement within 4 weeks for athlete's foot or ringworm, or 2 weeks for jock itch. Call if irritation develops. Call right away if anyone swallows it.
📖 Read our full Tolnaftate guide →

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.

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: 1 u 3 us
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
84558-0022-01 You're viewing this Main listing 2 U in 1 BOX 2026-06-24 — Active
84558-0022-02 84558-022-02 3 U in 1 BOX 2026-06-24 — Active
84558-0022-03 84558-022-03 1 U in 1 BOX 2026-06-24 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 2-count package — 2 u in 1 box.
How does this package differ from NDC 84558-0022-03?
Both are antifungal pen 1 g/100U Liquid — the drug itself is identical. This page's package is the 2-count one, while NDC 84558-0022-03 is the 1 u package.
What NDC number is used to bill for this package of antifungal pen 1 g/100U 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/100Uthis 84558-0022-01 GUANGZHOU 2 us — — 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
Jun 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.

🧪 Avoiding an ingredient? See Tolnaftate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 YUSONG FINE CHEMICLS Co., Ltd
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code84558
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio26 products on file

More NDCs from GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd labeler code 84558

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

Use For the effective treatment of discoloration, thickening, splitting, crumbling and brittleness. Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Helps prevent most athlete's foot with daily use. Provides effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort.

⏱️ Dosage and Administration 66 words ▾

Directions Before first use, twist the end of the pen until liquid appears on the applicator tip. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice or three times daily, morning and night, or as directed by a doctor. This product is not effective on the scalp or nails.lf the condition persists longer, please consult a doctor.

⚠️ Warnings 67 words ▾

Warnings For external use only. Avoid contact with the eyes and mucous membranest. ln the event of oversensitivity, stop using dermavia+Fungal Nail Treatment liquid. Consult your doctor if there is no improvement within two weeks. Consult your doctor before using if you are pregnant or are breastfeeding. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 13 words ▾

Other information Storage: Store in a dry and dark place at room temperature(5-25°C).

🧪 Active Ingredient 4 words ▾

Active Ingredient(s) Tolnaftate 1%

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients Argania Spinosa Kernel Oil, Melaleuca Alternifolia Leaf Oil, Origanum Vulgare Oil, Prunus Amygdalus Dulcis Oil,Simmondsia Chinensis Seed Oil, Tocopherol, Vitis Vinifera Seed Oil.

🎯 Purpose 2 words ▾

Purpose Antifungal

📄 Do Not Use 9 words ▾

Do not use on open wounds or damaged skin

📄 When Using This Product 16 words ▾

avoid contact with eyes do not apply to irritated or broken skin use only as directed

📄 Stop Use and Ask a Doctor If 7 words ▾

If irritation occurs, stop using it immediately.

📄 Keep Out of Reach of Children 20 words ▾

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

📄 Package Label / Principal Display Panel 9 words ▾

Package Label - Principal Display Panel label label undefined

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 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 2 other package presentations of this same product, including 1 u (84558-0022-03), 3 us (84558-0022-02). 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.
← 84558-0020-01 · GUANGZHOU 84558-0023-01 · 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.