Osimoon Fungal Nail Treatment Kit 10 g/100mL Liquid — NDC 85150-0008-01 package photo

Osimoon Fungal Nail Treatment Kit 10 g/100mL Liquid

by Guangzhou Zanming Trading Co., Ltd. · 2 BOTTLE in 1 BOX (85150-008-01) / 15 mL in 1 BOTTLE
NDC 85150-0008-01
🏷️ FDA NDC (as labeled) 85150-008-01 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) 85150-008-01
Product NDC 85150-008
11-digit billing NDC 85150000801
RxCUI 1251008
UNII K3D86KJ24N
Application # M005
SPL Set ID 34aec10d-a0d0-d956-e063-6394a90a39b2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-09
Route TOPICAL
Dosage form LIQUID
Substance UNDECYLENIC ACID
Why two NDCs? The FDA registers this code as 85150-008-01 — 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 → 85150-0008-01. 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

LabelerGuangzhou Zanming Trading Co., Ltd.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85150
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio9 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 treats three common fungal skin infections: athlete's foot (the itchy, scaly condition that affects the feet and toes), jock itch (a fungal rash in the groin area), and ringworm...
  • What exactly does undecylenic acid treat?
  • For athlete's foot and ringworm, most products are used daily for 4 full weeks. For jock itch, 2 weeks of daily use is typically recommended. Some nail products note that visible i...
  • That depends on the product. Most undecylenic acid creams, sprays, and general topical solutions are not effective on nails and should not be used there. However, some products — l...
📖 Read our full Undecylenic 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.

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

  • UNII WCK3J2NNE4
    A synthetic waxy compound derived from long-chain fatty acids. This ingredient serves as an emulsifier and skin-conditioning agent, helping to blend oil and water components together and improve the texture and feel of topical medications.
  • UNII 54JB35T06A
    A natural oil extracted from apricot pits, used as an emollient and lubricant in topical products. It helps soften the skin and improves the texture and spreadability of creams and lotions.
  • UNII 39W1PKE3JI
    Bergamot oil is a citrus extract from bergamot orange peel. It's used as a flavoring and fragrance agent to improve taste and aroma in medicines.
  • UNII 75IZZ8Y727
    Camphor oil is a colorless to pale yellow essential oil derived from the camphor laurel tree. It's used in medicines as a flavoring agent and mild skin-soothing ingredient in topical formulations.
  • UNII CXM0P78DR3
    Diethylene glycol abietate is a synthetic compound made from a natural resin and a glycol alcohol. It works as a plasticizer and film-former in medicines, helping coatings stay flexible and adhere properly to tablets or capsules.
  • 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.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII SMD1X3XO9M
    Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
  • 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.
  • UNII 3XMK78S47O
    Testosterone is a natural hormone. In medicines, it serves as the active therapeutic ingredient rather than an inactive excipient, delivering the hormone that the formulation is designed to provide.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.

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

The official label also statesMineral oil, Apricot Kernel Oil, Tea Tree Oil,Tocopherol, Peppermint Oil, Camphor Oil, Jojoba Oil, Bergamot Oil, Lavender Oil, Hydrogel, Elastic fabric, Adhesive, Release paper

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 DailyMedingredient 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 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
EmoniNail Antifungal 100 mg/mL 65121-0071-08 Pure 24 ml FDA listed
EmoniNail Antifungal 100 mg/mL 76973-0071-08 GG 24 ml FDA listed
NEOMEN Nail Repair Pen 10 g/100mL 83887-0006-01 Changsha 3 ml Discontinued
Osimoon Fungal Nail Treatment Kit 10 g/100mLthis 85150-0008-01 Guangzhou 2 bottles FDA listed
BeamBalm ANTIFUNGAL CARE ESSENTIAL Oil 10 g/100mL 85248-0191-01 Jiangxi 10 ml FDA listed
OSIMOON Toenail Fungus Treatment 10 g/100mL 87408-0001-01 Guangzhou 2 bottles FDA listed
Tuymec FUNGAL NAIL TREATMENT Kit 10 g/100mL 87408-0004-01 Guangzhou 2 bottles FDA listed
Osimoon Fungal Nail Renewal 10 g/100mL 87408-0006-01 Guangzhou 2 bottles FDA listed
OSIMOON FUNGAL NAIL TREATMENT Kit 10 g/100mL 87408-0019-01 Guangzhou 2 bottles 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
May 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85150-0008-01 You're viewing this 2 BOTTLE in 1 BOX (85150-008-01) / 15 mL in 1 BOTTLE 2025-05-09 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 85150-008-01, 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: 85150-0008-01, written without dashes as 85150000801. 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 85150-0008-01, the first segment (85150) is the labeler code FDA assigned to Guangzhou Zanming Trading Co., Ltd.; the middle segment (0008) 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 Guangzhou Zanming Trading Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangzhou Zanming Trading 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.

📄 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 12 words

Use Effective in getting rid of fungus and promoting healthier nail growth.

⏱️ Dosage and Administration 86 words

Directions • Clean the affected area with soap, soak the nail in warm water to soften it. • Then let it dry, apply a thin layer of the antifungal solution included in the kit 2-3 times a day. • Apply the fungus nail patch once a night. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips. • Keep the patch in this position for 6-8 hours, preferably overnight, and recommended for 3-6 months.

⚠️ Warnings 72 words

Warnings • For external use only. • When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. • Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation or symptoms worsen or last for more than 4 weeks. • Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

📦 Storage and Handling 11 words

Other information Store at room temperature. Reseal pouch after each use.

🧪 Active Ingredient 6 words

Active Ingredient Undecylenic Acid 10% W/W

🧪 Inactive Ingredients 26 words

Inactive ingredients Mineral oil, Apricot Kernel Oil, Tea Tree Oil,Tocopherol, Peppermint Oil, Camphor Oil, Jojoba Oil, Bergamot Oil, Lavender Oil, Hydrogel, Elastic fabric, Adhesive, Release paper

🎯 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.