NDC 85817-0008-01 — AlphaTip Nail Repair Pen 20 g/100mL Liquid

🆔 Identity & classification

FDA NDC (as labeled) 85817-008-01

Product NDC 85817-008

11-digit billing NDC 85817000801

RxCUI 1437295

UNII K3D86KJ24N

Application # M005

SPL Set ID 435c7973-8a67-8f51-e063-6394a90af58f

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2025-11-12

Route TOPICAL

Dosage form LIQUID

Substance UNDECYLENIC ACID

Why two NDCs? The FDA registers this code as 85817-008-01 — 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 → 85817-0008-01. 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 Qiexiran Cosmetics Co., Ltd.

FDA applicationM005 (OTC MONOGRAPH DRUG)

Labeler code85817

First marketedNov 2025

Product typeHuman Otc Drug

Portfolio9 products on file

🔎 All NDCs from Guangzhou Qiexiran Cosmetics Co., Ltd.

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 →

Patient education

📘 MedlinePlus patient leaflet ↗

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 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 K49155WL9Y
Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
UNII YPX537PA31
A plant extract from chrysanthellum indicum used as a natural colorant or flavoring agent in medicines. It may help create visual appeal or subtle taste characteristics in the formulation.
UNII H74221J5J4
Myrrh oil is a fragrant resin extracted from myrrh tree bark. It is used in medicines as a flavoring agent and to add aroma or taste to the product.
UNII T55ULQ060E
A waxy ester derived from plant sterols and fatty acids. It functions as an emollient and thickening agent in topical formulations, helping to soften skin and provide a smooth texture to creams or ointments.
UNII 91GW059KN7
Ethylene is a simple gas derived from petroleum. In medicines, it may be used as a propellant in aerosol inhalers or sprays to help deliver the active drug to the lungs or skin.
UNII ZBP1YXW0H8
A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
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 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 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.

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

The official label also statesMineral Oil, Ethylene/Propylene/Styrene Copolymer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Commiphora Myrrha Oil, Chrysanthellum Indicum Extract, Phytosteryl Oleate, Lavandula Angustifolia (Lavender) Oil.

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 system	Per mL	Per 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Hongocura Pinceladas 200 mg/mL 53145-0019-01	Menper	1 bottle	—	—	FDA listed	—
AlphaTip Nail Repair Pen 20 g/100mLthis 85817-0008-01	Guangzhou	2 tubes	—	—	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

Nov 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 NDC	Description	Marketing start	Status
85817-0008-01 You're viewing this	2 TUBE, WITH APPLICATOR in 1 BOX (85817-008-01) / 3 mL in 1 TUBE, WITH APPLICATOR	2025-11-12	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 85817-008-01, 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: 85817-0008-01, written without dashes as 85817000801. 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 85817-0008-01, the first segment (85817) is the labeler code FDA assigned to Guangzhou Qiexiran Cosmetics 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 Qiexiran Cosmetics Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Guangzhou Qiexiran 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.

📄 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

🎯 Indications and Usage 24 words ▾

Use For the treatment of most athlete’s foot (tinea pedis) For the treatment of ringworm (tinea corporis) Helps prevent recurrence of these fungal infections

⏱️ Dosage and Administration 31 words ▾

Directions Clean the affected area and dry thoroughly. Apply a thin layer over affected area twice daily (morning and night). Use daily for 4 weeks; if condition persists, consult a doctor.

⚠️ Warnings 41 words ▾

Warnings Do not use on children under 2 years of age unless directed by a doctor. Stop use and ask a doctor if irritation occurs or condition persists. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 18 words ▾

Other information Skin discoloration may occur during or after use. Protect from excessive heat (above 40°C / 104°F)

🧪 Active Ingredient 5 words ▾

Active Ingredient Undecylenic Acid 20%

🧪 Inactive Ingredients 35 words ▾

Inactive ingredients Mineral Oil, Ethylene/Propylene/Styrene Copolymer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Commiphora Myrrha Oil, Chrysanthellum Indicum Extract, Phytosteryl Oleate, Lavandula Angustifolia (Lavender) Oil.

🎯 Purpose 2 words ▾

Purpose Anti-Fungal

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

🔗 Related NDC lookups

🧪 All Nail Repair Pen NDCsSame ingredient 🏭 All Guangzhou labeler NDCsLabeler code 85817