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Antifungal Liquid Tolnaftate 10 mg/mL Liquid — NDC 55319-0995-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Antifungal Liquid Tolnaftate 10 mg/mL Liquid — NDC 55319-995-01 (Billing 55319-0995-01)

by Family Dollar Services, Inc · 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 30 mL in 1 BOTTLE, WITH APPLICATOR

This is a package of Antifungal Liquid Tolnaftate 10 mg/mL Liquid from Family Dollar Services, Inc, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 55319-0995-01
🏷️ FDA NDC (as labeled) 55319-995-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 20, 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 55319-995-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55319 labeler · 995 product · 01 package
Package marketed since
Jul 28, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0032251116971
FDA record last changed
Aug 20, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55319-995-01
Product NDC 55319-995
11-digit billing NDC 55319099501
RxCUI 313423
UNII 06KB629TKV
UPC 0032251116971
Application # M005
SPL Set ID 57c20748-fdad-b73b-e063-6294a90a1c17
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-28
Route TOPICAL
Dosage form LIQUID
Substance TOLNAFTATE
Quick answers
  • RxCUI (RxNorm): 313423
Why two NDCs? The FDA registers this code as 55319-995-01 — 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 → 55319-0995-01. 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.

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 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 →
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.
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
55319-0995-01 You're viewing this Main listing 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 30 mL in 1 BOTTLE, WITH APPLICATOR 2026-07-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Maximum Strength Antifungal Liquid 10 mg/mL 79481-0660-01 Meijer 1 bottle — — FDA listed —
Maximum Strength Antifungal Liquid 10 mg/mL 67091-0753-30 WinCo 1 bottle — — Discontinued —
Antifungal Liquid 10 mg/mL 70000-0745-01 LEADER/ 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 —
Formula 3 10 mg/mL 49406-0003-15 The 1 bottle — — FDA listed —
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 10 mg/mL 70000-0680-01 LEADER/Cardinal 1 bottle — — FDA listed —
Maximum Strength Antifungal Liquid 10 mg/mL 72446-0013-01 Hudson 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 82442-0956-01 Target 1 bottle — — FDA listed —
Maximum Strength Antifungal Liquid 10 mg/mL 83324-0301-01 Chain 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 36800-0399-01 TopCo 1 bottle — — FDA listed —
Toe Area Treatment 10 mg/mL 51316-0981-01 CVS 1 bottle — — FDA listed —
Liquid Antifungal Treatment 10 mg/mL 72446-0012-01 Hudson 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 79903-0256-30 Wal-Mart 1 bottle — — FDA listed —
Antifungal Solution Maximum Strength 10 mg/mL 11822-9600-01 Rite 1 bottle — — Discontinued —
Proclearz Professional Fungal Shield 10 mg/mL 29784-0184-01 Rooftop 1 bottle — — FDA listed —
Fungi Nail Toe and Foot 10 mg/mL 55505-0177-26 Kramer 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 82442-0998-01 Target 1 bottle — — FDA listed —
ProClearz Maximum Strength Fungal Shield Brush-on Antifungal 10 mg/mL 29784-0181-02 Rooftop 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 55319-0538-01 Family 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 56104-0902-01 Premier 1 bottle — — FDA listed —
Antifungal Liquid Maximum Strength 10 mg/mL 00363-7998-01 Walgreens 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mLthis 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1364PS73AF
    Acetone is a clear, volatile liquid solvent. In medications, it helps dissolve or extract active ingredients during manufacturing and may be used in certain liquid formulations or coating processes.
  • 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 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 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.

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

The official label also statesAcetone, Propylene Glycol,Tocopherol Acetate, 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.

Manufacturer & labeler

LabelerFamily Dollar Services, Inc
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code55319
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Family Dollar Services, Inc labeler code 55319

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 🧪 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 📄 Other Information 📄 Questions or Comments 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

Uses proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) prevents the recurrence of most athlete's foot with daily use for effective relief of itching, burning, cracking, redness and scaling

⏱️ Dosage and Administration 116 words ▾

​Directions clean the affected area and dry thoroughly apply a thin layer of the product over the 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 to prevent athlete's foot: wash the feet and dry thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and/or night) this product is not effective on the scalp or nails

⚠️ Warnings 66 words ▾

Warnings For external use only. 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 there is no improvement within 4 weeks Keep out of reach of children. If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 4 words ▾

​Active ingredient Tolnaftate 1%

🧪 Inactive Ingredients 7 words ▾

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

🎯 Purpose 2 words ▾

​Purpose Antifungal

📄 Do Not Use 15 words ▾

Do not use on children under 2 years of age unless directed by a doctor.

📄 When Using This Product 9 words ▾

When using this product avoid contact with the eyes.

📄 Stop Use and Ask a Doctor If 16 words ▾

Stop use and consult a doctor if irritation occurs there is no improvement within 4 weeks

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

📄 Other Information 32 words ▾

​Other information ​ SHAKE WELL BEFORE USE store at room temperature 15°-30°C (59° - 86°F) protect from freezing; if freezing occurs, warm to room temperature keep tightly closed when not in use

📄 Questions or Comments 3 words ▾

Questions? Call 1-866-964-0939

📄 Recent Major Changes 1 words ▾

.

📄 Package Label / Principal Display Panel 65 words ▾

Principal Display Panel FAMILY Wellness MAXIMUM STRENGTH ANTIFUNGAL LIQUID TOLNAFTATE 1%/ ANTIFUNGAL Proven clinically effective in the treatment of fungus on fingers, toes & skin around nails Prevents the recurrence of most athlete's foot with daily use Relieves: Itching Burning Scaling Built-in brush for easy application With moisturizing ingredients *This product is not effective on the scalp or nails 1 FL. OZ. (30 mL) CARTON

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Tolnaftate — the ingredient across all brands.

Top reported reactions

Pain94
Fatigue88
Nausea86
Dyspnoea81
Diarrhoea73
Anxiety69
Headache57

Age at onset

Infant3
Child12
Adolescent3
Adult103
Elderly83

Reporter sex

1,403 reports
Male · 45%
Female · 55%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 108 37
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.

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 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 Family Dollar Services, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Family Dollar Services, Inc 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.
← 55319-0991-00 · Family 55322-0001-01 · Diamond →
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.