HomeNDC LookupIngredientsTolnaftate › 72446-0012-01
Liquid Antifungal Treatment Tolnaftate 10 mg/mL Liquid — NDC 72446-0012-01 package photo

Liquid Antifungal Treatment Tolnaftate 10 mg/mL Liquid

by Hudson Health LLC · 1 BOTTLE, WITH APPLICATOR in 1 CARTON (72446-012-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR
NDC 72446-0012-01
🏷️ FDA NDC (as labeled) 72446-012-01 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 →

🆔 Identity & classification

FDA NDC (as labeled) 72446-012-01
Product NDC 72446-012
11-digit billing NDC 72446001201
RxCUI 313423
UNII 06KB629TKV
Application # M005
SPL Set ID 14a9efd8-e49f-12fa-e063-6394a90aa8a0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-03-29
Route TOPICAL
Dosage form LIQUID
Substance TOLNAFTATE
Why two NDCs? The FDA registers this code as 72446-012-01 — 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 → 72446-0012-01. 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

LabelerHudson Health LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code72446
First marketedMar 2024
Product typeHuman Otc Drug
Portfolio10 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 it is MedlinePlus · NLM

Tolnaftate stops the growth of fungi that cause skin infections, including athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on what you're treating. For athlete's foot and ringworm, plan on using it daily for about 4 weeks. For jock itch, 2 weeks is the usual course. Some products mention you...
  • How long does it take for tolnaftate to work?
  • Tolnaftate is not effective for treating infections on the scalp or on the nails themselves — most products say so right on the label. Some liquid and patch products are designed t...
  • Stop applying the product and let your doctor know. A little initial sensitivity can happen, but worsening irritation is a sign that you should get it checked out. Don't push throu...
📖 Read our full Tolnaftate guide →
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.

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.

💲 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
Maximum Strength Antifungal Liquid 10 mg/mL 00363-2026-01 Walgreens 1 bottle FDA listed
Antifungal Liquid 10 mg/mL 00363-4471-01 Walgreens 1 bottle FDA listed
Antifungal Liquid Maximum Strength 10 mg/mL 00363-7998-01 Walgreens 1 bottle FDA listed
Antifungal Solution Maximum Strength 10 mg/mL 11822-9600-01 Rite 1 bottle FDA listed
Meijer Maximum Strength Athletes Foot Antifungal 10 mg/g 23667-0811-01 Formulated 150 g Discontinued
Signature Care Athletes Foot Antifungal 10 mg/g 23667-0813-01 Formulated 150 g Discontinued
Up and Up Soothing Antifungal 10 mg/g 23667-0816-01 Formulated 150 g Discontinued
ProClearz Maximum Strength Fungal Shield Brush-on Antifungal 10 mg/mL 29784-0181-02 Rooftop 1 bottle FDA listed
Proclearz Professional Fungal Shield 10 mg/mL 29784-0184-01 Rooftop 1 bottle FDA listed
Antifungal Liquid 10 mg/mL 36800-0399-01 TopCo 1 bottle FDA listed
CLARUS Antifungal 1 g/100mL 44577-0002-01 Clinical 15 ml FDA listed
CLARUS AC Antifungal Solution 10 mg/g 44577-0128-00 Clinical 15 g FDA listed
Formula 3 10 mg/mL 49406-0003-15 The 1 bottle FDA listed
Formula 7 - The Solution 1 g/100g 49406-0007-15 The 15 g FDA listed
Hi Vetic 1 g/100mL 49873-0050-02 Sato 1 bottle FDA listed
Silka Antifungal 1 g/100mL 50066-0085-01 Genomma 1 bottle FDA listed
Nail Renovar Plus 1 g/100mL 50405-0030-02 SOHM, 15 ml FDA listed
CIDACIN Antifungal Treatment 1 g/100mL 51151-0000-01 Pedicis 1 bottle FDA listed
Maximum Strength Antifungal Liquid .3 g/30mL 51316-0898-00 CVS 30 ml FDA listed
Toe Area Treatment 10 mg/mL 51316-0981-01 CVS 1 bottle FDA listed
Fungicure Anti-Fungal Liquid 8.65 mg/mL 52389-0298-30 Kobayashi 1 bottle FDA listed
Antifungal Liquid 10 mg/mL 55319-0538-01 Family 1 bottle FDA listed
Fungi Nail Toe and Foot 10 mg/mL 55505-0177-26 Kramer 1 bottle FDA listed
Fungi Nail Anti-Fungal Pen 1 g/100mL 55505-0193-51 Kramer 1 tube FDA listed
Opti-Nail 2-in-1 1 g/100mL 55505-0219-67 Kramer 5 ml FDA listed
Antifungal Liquid 10 mg/mL 56104-0902-01 Premier 1 bottle FDA listed
Mycozyl AL .3 g/30mL 59088-0443-03 PureTek 30 ml FDA listed
Micotrin AL .3 g/30mL 59088-0477-03 PureTek 30 ml FDA listed
Micomitin Antifungal .3 g/30mL 59088-0640-03 PureTek 30 ml FDA listed
Nail Renew 1 g/100mL 62858-0101-51 Nailrenew 1 bottle FDA listed
Maximum Strength Antifungal Liquid 10 mg/mL 67091-0753-30 WinCo 1 bottle FDA listed
Antifungal Liquid 10 mg/mL 70000-0680-01 LEADER/Cardinal 1 bottle FDA listed
Antifungal Liquid 10 mg/mL 70000-0745-01 LEADER/ 1 bottle FDA listed
Liquid Antifungal Treatment 10 mg/mLthis 72446-0012-01 Hudson 1 bottle FDA listed
Maximum Strength Antifungal Liquid 10 mg/mL 72446-0013-01 Hudson 1 bottle FDA listed
Novonail Solution 1 g/100mL 72839-0507-01 Derma 13.3 ml FDA listed
Dermatool Fungal Nail Treatment 1 g/100mL 72839-0510-01 Derma 1 bottle FDA listed
Tritolnacide S .01 g/mL 73352-0560-01 Trifluent 15 ml FDA listed
Maximum Strength Antifungal Liquid 10 mg/mL 79481-0660-01 Meijer 1 bottle FDA listed
Antifungal Liquid 10 mg/mL 79903-0256-30 Wal-Mart 1 bottle FDA listed
Antifungal Liquid 10 mg/mL 79903-0394-01 Wal-Mart 1 bottle FDA listed
Maximum Strength Antifungal Liquid 10 mg/mL 81522-0077-01 FSA 1 bottle FDA listed
Antifungal Liquid 10 mg/mL 82442-0956-01 Target 1 bottle FDA listed
Antifungal Liquid 10 mg/mL 82442-0998-01 Target 1 bottle FDA listed
Maximum Strength Antifungal Liquid 10 mg/mL 83324-0301-01 Chain 1 bottle FDA listed
Toe Fungus 1 g/100mL 83837-0001-01 Imperial 75 ml FDA listed
Athletes Foot 1 g/100mL 83837-0002-01 Imperial 75 ml FDA listed
Nailtific Nighttime Antifungal Renewal Pen Refill .06 g/6mL 84167-0023-31 Guangzhou 1 bottle FDA listed
APUREE Nailtific Extra-Max Strength Nighttime Antifungal 1 g 84167-0479-02 Guangzhou 1 vial FDA listed
Nail Lab Fungomer Nailelixir 1 g/100mL 84222-0002-01 Foshan 50 ml Discontinued
TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid 1 g/100mL 84614-0002-01 Shenzhen 2 bottles FDA listed
Dermatool Fungal Nail Treatment 1 g/100mL 84728-0510-01 Papalo 1 bottle FDA listed
Nekvnro FUNGAL NAIL TREATMENT Kit 1 g/100mL 84844-0019-01 Guoyu 2 bottles Discontinued
Ukova Foot Odor Probiotic 1 g/100mL 84867-0011-01 Jiashen 30 ml FDA listed
UKVOA Toenail Fungus Treatment 1 g/100mL 84867-0012-01 Jiashen 30 ml FDA listed
Alveora NAIL FUNGUS TREATMENT 1 g/100mL 85248-0033-01 Jiangxi 30 ml FDA listed
Dermfree Fungi Nail 1 g/100mL 85248-0037-01 Jiangxi 15 ml FDA listed
Cndanting Multi-Purpose Nail Repair 1 g/100mL 85248-0040-01 Jiangxi 30 ml FDA listed
BeamBalm FUNGL NAIL 1 g/100mL 85248-0047-01 Jiangxi 4 ml FDA listed
BeamBalm ANTIFUNGAL NAIL 1 g/100mL 85248-0048-01 Jiangxi 11 ml Discontinued
Skapemed Skin Repair 1 g/100mL 85248-0054-01 Jiangxi 50 ml FDA listed
Healmusz Fungi Nail 1 g/100mL 85248-0057-01 Jiangxi 15 ml FDA listed
HEALMUSZ Multi-PurposeTreatment 1 g/100mL 85248-0058-01 Jiangxi 30 ml FDA listed
Reinreude Multi-Purpose Treatment 1 g/100mL 85248-0072-01 Jiangxi 30 ml FDA listed
Natuheal Multi -Purpose Treatment 1 g/100mL 85248-0081-01 Jiangxi 30 ml FDA listed
Ourui One Fungal Nail Treatment 1 g/100mL 85248-0084-01 Jiangxi 2 bottles FDA listed
PUVIDA Helps WITH NAGELPILZ 1 g/100mL 85248-0089-01 Jiangxi 2.5 ml FDA listed
FIobow FUNGAL NAIL TREATMENT 1 g/100mL 85248-0095-01 Jiangxi 30 ml FDA listed
Serynth Fungi Nail 1 g/100mL 85248-0108-01 Jiangxi 15 ml FDA listed
Serynth Helps With Fungal Nail 1 g/100mL 85248-0109-01 Jiangxi 2.5 ml FDA listed
Dermfree Helps With Nagelpilz 1 g/100mL 85248-0115-01 Jiangxi 4 ml FDA listed
Folupia Fungal Nail Renewal 1 g/100mL 85248-0148-01 Jiangxi 30 ml FDA listed
Tolfyra .3 g/30mL 85477-0331-01 Oncora 30 ml FDA listed
Nail Fungus Treatment 1 g/100mL 85834-0001-01 Shenzhen 30 ml Discontinued
Cureforte Anti Fungal Foot Care 10 mg/mL 85884-0252-02 STEEL 1 bottle FDA listed
zourunan MULTI-PURPOS TREATMENT 1 g/100mL 87083-0001-01 Guchutang 30 ml FDA listed
Dr. Luke FUNGAL NAIL RENEWAL 1 g/100mL 87147-0005-01 DANOUS 30 ml Discontinued
nail fungus treatment 1 mg/100mg 87770-0003-01 Guangzhou 30 mg FDA listed
Antifungal Liquid 10 mg/mL 55319-0995-01 Family 1 bottle 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
Mar 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.

🔬 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 Liquid Antifungal Treatment (this brand).

Top reported reactions

Arthralgia17
Diarrhoea16
Fatigue13
Headache13
Rash Erythematous13
Blood Potassium Increased12
Bronchopulmonary Aspergillosis11

Age at onset

Child5
Adult15
Elderly14

Reporter sex

185 reports

Serious outcomes

Hospitalization64
Death12
Disabling9
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 18 4
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72446-0012-01 You're viewing this 1 BOTTLE, WITH APPLICATOR in 1 CARTON (72446-012-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR 2024-03-29 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) — 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 FDA registers it as 72446-012-01, 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: 72446-0012-01, written without dashes as 72446001201. 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 72446-0012-01, the first segment (72446) is the labeler code FDA assigned to Hudson Health LLC; 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 Hudson Health LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hudson Health LLC 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 23 words

Uses for the treatment of athlete’s foot (tinea pedis) and ringworm (tinea corporis) for effective relief of itching, scaling, cracking, burning and redness.

⏱️ Dosage and Administration 88 words

​Directions wash the affected area and dry thoroughly. apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. supervise children in the use of this product. 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 ringworm, use daily for 4 weeks. if condition persists longer, consult a doctor. this product is not effective on the scalp or nails.

⚠️ Warnings 73 words

Warnings For external use only. Flammable keep away from fire or flame. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes. Stop use and consult a doctor if irritation occurs or if there is no improvement within 4 weeks Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

🧪 Active Ingredient 4 words

​Active ingredient Tolnaftate 1%

🧪 Inactive Ingredients 8 words

​Inactive ingredient Acetone, Water, Propylene Glycol, Tocopherol Acetate.

🎯 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 ↗
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.