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Initial Treatonic FUNGAL NAIL RENEWAL PATCHES Tolnaftate 1% 1 mg/1001 Patch, 33554432 patches — NDC 85569-0013-01 package photo

Initial Treatonic FUNGAL NAIL RENEWAL PATCHES Tolnaftate 1% 1 mg/1001 Patch, 33554432 patches

by 100 KARMA INC · 32 PATCH in 1 PATCH (85569-013-01)
NDC 85569-0013-01
🏷️ FDA NDC (as labeled) 85569-013-01 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 →

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) 85569-013-01
Product NDC 85569-013
11-digit billing NDC 85569001301
RxCUI 2677690
UNII 06KB629TKV
Application # M005
SPL Set ID 48e377b4-abb1-34cf-e063-6294a90a2ea3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-18
Route TOPICAL
Dosage form PATCH
Substance TOLNAFTATE
Why two NDCs? The FDA registers this code as 85569-013-01 — 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 → 85569-0013-01. 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

Labeler100 KARMA INC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85569
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio15 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

📗 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 →

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 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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.
  • 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.

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

The official label also statesWater, Glycerin, Sodium Carboxymethyl Cellulose,Butylene Glycol, Urea

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 eachPer 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
FungiFree Fungal Nail Patches 1 g/100g 83364-0013-01 YITONGBADA 4084101 patches — — FDA listed —
APUREE Pure Nailtific Extra-Strength Fungal Nail Patches 1 g 84167-0332-23 Guangzhou 5 patches — — FDA listed —
APUREE PRO Nailtific Maximum Strength Antifungal Patches 1 g 84167-0335-01 Guangzhou 2 patches — — FDA listed —
APUREE Nailtific Maximum Strength Antifungal Patches PRO 1 g 84167-0416-01 Guangzhou 2 patches — — FDA listed —
Puvida Fungal Nail 1 g/1001 85248-0153-01 Jiangxi 32 patches — — FDA listed —
NATURAL CURES FUNGAL NAIL Patches 1 g/1001 85248-0202-01 Jiangxi 52 patches — — FDA listed —
HuiPoLii NAIL PFLASTER 1 g/1001 85248-0206-01 Jiangxi 32 patches — — FDA listed —
TINGOLE FUNGAL NAIL Patches 1 g/1001 85248-0221-01 Jiangxi 21 patches — — FDA listed —
Fungal Nail Nighttime Renewal Patches 1 g/1001 85569-0009-01 100 33554432 patches — — FDA listed —
Initial Treatonic FUNGAL NAIL RENEWAL PATCHES 1 mg/1001this 85569-0013-01 100 33554432 patches — — FDA listed —
Fungal Nail Patches .01 g 85966-0006-01 GUANGZHOU 32 patches — — FDA listed —
Saviland PRO Extra Strength Toenail Renewal Patches .01 g 85966-0014-01 GUANGZHOU 35 patches — — FDA listed —
Saviland SSPro X Series Extra Strength Toenail Renewal Patches .01 g 85966-0015-01 GUANGZHOU 18 patches — — FDA listed —
SSPROTIP X Extra Strength Nail Renewal Patches .01 g 85966-0016-01 GUANGZHOU 38 patches — — FDA listed —
Vrenmol Extra Strength Nail Renewal Patches .01 g 85966-0018-01 GUANGZHOU 34 patches — — FDA listed —
Natural Vine Fungal Nail patches 1 mg/1001 87870-0005-01 GETHSEMANE 33554432 patches — — FDA listed —
Natural Vine Fungal Nail Green Patches 1 mg/1001 87870-0006-01 GETHSEMANE 32 patches — — 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
Feb 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.

🔬 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 Initial Treatonic FUNGAL NAIL RENEWAL PATCHES (this brand).

Top reported reactions

Muscular Weakness1

Reporter sex

1 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 0
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
85569-0013-01 You're viewing this 32 PATCH in 1 PATCH (85569-013-01) 2026-02-18 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 85569-013-01, 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: 85569-0013-01, written without dashes as 85569001301. 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 85569-0013-01, the first segment (85569) is the labeler code FDA assigned to 100 KARMA INC; the middle segment (0013) 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 100 KARMA INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
100 KARMA 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.

📄 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 54 words ▾

Clean & prepare the affected nail, Applythe antifungal solution to the affected nail. Apply the fungus nail patch, Fimly secure the patch to the sides of the toes or fingers,folding the remaining achesive partto fully cover the toes/fingertips. Leave the patch on for 6-8 hours.Frequency. Use the patches consistently before bed. Maintain good foothygiene.

⏱️ Dosage and Administration 20 words ▾

Helps inhibit the growth of fungus. Improves the appearance of nails affected by fungus,including discoloration, thickening, splitting, crumbing, and brittleness.

⚠️ Warnings 66 words ▾

For external use only on children under 2years of age unless directed lby a doctor on dliaper rash Avoid contact with eyes. do not exceed the recommended daily dosage unless directed by a doctor. iritation occurs there is no improvement within 4 weeks. ask a health professional before use. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

🧪 Active Ingredient 2 words ▾

Tolnaftate 1%

🧪 Inactive Ingredients 7 words ▾

Water, Glycerin, Sodium Carboxymethyl Cellulose,Butylene Glycol, Urea

🎯 Purpose 1 words ▾

Antifungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85569-0012-01 · 100 85569-0014-01 · 100 →
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.