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NAIL LAB FUNGOMER NAILELIXIR Tolnaftate 1% 1 g/100mL Oil, 3 mL — NDC 84222-0002-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

NAIL LAB FUNGOMER NAILELIXIR Tolnaftate 1% 1 g/100mL Oil, 3 mL — NDC 84222-002-02 (Billing 84222-0002-02)

by Foshan Miwei Cosmetics Co., Ltd. · 3 mL in 1 TUBE, WITH APPLICATOR

This is a package of 3 mL of NAIL LAB FUNGOMER NAILELIXIR Tolnaftate 1% 1 g/100mL Oil from Foshan Miwei Cosmetics Co., Ltd., no longer marketed (first marketed Aug 2024), no longer in the FDA NDC Directory.

NDC 84222-0002-02
🏷️ FDA NDC (as labeled) 84222-002-02 billing pads the product segment with a zero
This package
Contains3 mL Pack sizes2 compare ↓
Product page 84222-0002-01 Also comes in: 50 ml 84222-002-01
OTC Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84222-002-02
Product NDC 84222-002
11-digit billing NDC 84222000202
RxCUI 313423
UNII 06KB629TKV
Application # M005
SPL Set ID 1f77d7f6-1fb0-26da-e063-6394a90a5985
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2024-08-28
Route TOPICAL
Dosage form OIL
Substance TOLNAFTATE
Quick answers
  • RxCUI (RxNorm): 313423
Why two NDCs? The FDA registers this code as 84222-002-02 — 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 → 84222-0002-02. 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

📗 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 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.
Try another pack size: 50 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84222-0002-01 84222-002-01 Main listing 50 mL in 1 BOTTLE, GLASS 2024-08-28 — Inactivated by FDA
84222-0002-02 You're viewing this 3 mL in 1 TUBE, WITH APPLICATOR 2024-08-28 — Inactivated by FDA

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

Pack size FAQ

What quantity is in this package?
This package contains 3 mL — 3 ml in 1 tube, with applicator.
How does this package differ from NDC 84222-0002-01?
Both are NAIL LAB FUNGOMER NAILELIXIR Tolnaftate 1% 1 g/100mL Oil — the drug itself is identical. This page's package is the 3 mL one, while NDC 84222-0002-01 is the 50 ml package.
What NDC number is used to bill for this package of NAIL LAB FUNGOMER NAILELIXIR Tolnaftate 1% 1 g/100mL Oil?
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
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 — — Discontinued —
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 — — Discontinued —
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/mL 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/100mLthis 84222-0002-02 Foshan 3 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 — — Discontinued —
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 —
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
Aug 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.

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.

  • 1 mL / 100 mL 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.
  • 20 mL / 100 mL 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.
  • 5 mL / 100 mL UNII 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • 49.95 mL / 100 mL UNII 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
  • 20 mL / 100 mL 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.
  • 0.15 mL / 100 mL UNII GFD7C86Q1W
    A natural oil extracted from citrus peels, (+)-limonene is used as a flavoring agent and solvent in medicines. It helps dissolve active ingredients and provides a lemon or orange taste.
  • 0.0015 mL / 100 mL UNII D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • 1 mL / 100 mL UNII 7D0CGR40U1
    A natural oil extracted from oregano leaves, used as a flavoring agent and preservative in medicines. It adds taste and may help protect the product from degradation.
  • 2.85 mL / 100 mL 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.

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

The official label also statesInactive Ingredients: Vitis Vinifera Seed Oil, Simmondsia Chinensis Seed Oil, Prunus Amygdalus Dulcis Oil, Argania Spinosa Kernel Oil, Melaleuca Alternifolia Leaf Oil, Tocopheryl Acetate, Origanum Vulgare Oil, Limonene, Linalool

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

LabelerFoshan Miwei Cosmetics Co., Ltd.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code84222
First marketedAug 2024
Product typeHuman Otc Drug
Portfolio4 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.

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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Uses For all caused by nail fungus Nail discoloration Nail thickening Nail splitting Nail crumbling

⏱️ Dosage and Administration 108 words ▾

Directions: Soak your nails in warm water for 10-15 minutes. Gently dry the needed area using a clean paper towel. Use the nail file to remove the soft part of the nail.

Apply a few drops of oil on the needed area using the pipette. Spread the liquid over the cuticles and nearby skin using the brush. Gently massage the solution into the needed area.

Allow the solution to absorb for 10-1 5 minutes. Avoid contact with eyes and mouth. Repeat 3 times a day.

Recommended to leave on overnight. Travel Pen: Rotate the top clockwise to dispense the solution. Designed for your convenience, making every trip easier.

⚠️ Warnings 62 words ▾

Warnings External Use Only. Avoid contact with eyes and mouth. If contact occurs, rinse immediately. Test on a small skin area 24 hours before full use. Discontinue if irritation occurs. Keep out of reach of children. If pregnant or nursing, seek medical advice before use. Avoid mixing with other products. Check the expiry date. Do not apply to broken or inflamed skin.

📦 Storage and Handling 10 words ▾

Store in a cool, dry place, away from direct sunlight.

🧪 Active Ingredient 4 words ▾

Active Ingredient Tolnaftate 1%

🧪 Inactive Ingredients 29 words ▾

Inactive Ingredients: Vitis Vinifera Seed Oil, Simmondsia Chinensis Seed Oil, Prunus Amygdalus Dulcis Oil, Argania Spinosa Kernel Oil, Melaleuca Alternifolia Leaf Oil, Tocopheryl Acetate, Origanum Vulgare Oil, Limonene, Linalool

🎯 Purpose 2 words ▾

Purpose Antifungal

📄 Do Not Use 8 words ▾

Do not apply to broken or inflamed skin.

📄 When Using This Product 22 words ▾

Avoid contact with eyes and mouth. If contact occurs, rinse immediately. Test on a small skin area 24 hours before full use.

📄 Stop Use and Ask a Doctor If 4 words ▾

Discontinue if irritation occurs.

🤰 If Pregnant or Breast-Feeding 9 words ▾

If pregnant or nursing, seek medical advice before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 50 words ▾

Other information: Store in a cool, dry place, away from direct sunlight. Ensure nail enhancement equipment is sterilized prior to each application. Utilize only uncontaminated and sanitized supplies. Maintain nails by keeping them neatly trimmed and devoid of any accumulated debris. Should any concerns arise, seek professional medical consultation. promptly.

📄 Questions or Comments 5 words ▾

Questions? Email: support @ nail-lab.co

📄 Package Label / Principal Display Panel 4 words ▾

design 1 design 2

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 1% — the ingredient across all brands.

Top reported reactions

Diarrhoea23
Arthralgia17
Dyspnoea17
Fatigue15
Nausea14
Pneumonia14
Blood Potassium Increased13

Reporter sex

288 reports

Serious outcomes

Hospitalization99
Death41
Disabling10
Life-threatening7
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 24 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 ml (84222-0002-01). 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?
Foshan Miwei Cosmetics 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.
← 84222-0001-01 · Foshan 84222-0003-01 · Foshan →
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.