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Nail Repairs Patches GLYCERIN .012 mg/60mg; .012 mg/60mg Patch, 60 mg — NDC 84989-0016-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nail Repairs Patches GLYCERIN .012 mg/60mg; .012 mg/60mg Patch, 60 mg — NDC 84989-016-01 (Billing 84989-0016-01)

by Shantou Ximonth Biotechnology Co., Ltd. · 60 mg in 1 BOX

This is a package of 60 mg of Nail Repairs Patches GLYCERIN .012 mg/60mg; .012 mg/60mg Patch from Shantou Ximonth Biotechnology Co., Ltd., marketed since Jan 2026 and currently FDA-listed. It is this product's only package size.

NDC 84989-0016-01
🏷️ FDA NDC (as labeled) 84989-016-01 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 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

NDC database record

One package, one record: these facts belong to NDC 84989-016-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84989 labeler · 016 product · 01 package
Package marketed since
Jan 16, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8498901601 7
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Glycerin (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 27, 2026 — Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. (Oasis Medical, Inc.) · FDA recall D-0525-2026
Class II · Apr 20, 2026 — Lack of Assurance of Sterility (SCOPE HEALTH) · FDA recall D-0499-2026
Class II · Mar 25, 2026 — Lack of Assurance of Sterility (Preferred Pharmaceuticals, Inc.) · FDA recall D-0443-2026
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0411-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84989-016-01
Product NDC 84989-016
11-digit billing NDC 84989001601
UNII ZY81Z83H0X, IYR6K8KQ5K
Application # M016
SPL Set ID 48793a50-89a7-dba9-e063-6394a90a7056
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-16
Route TOPICAL
Dosage form PATCH
Substance ALOE BARBADENSIS LEAF; SOPHORA FLAVESCENS ROOT
Why two NDCs? The FDA registers this code as 84989-016-01 — 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 → 84989-0016-01. 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.

Clinical

🧪 What is this product?

Nail Repairs Patches is an over-the-counter topical patch product formulated with aloe barbadensis leaf and sophora flavescens root as active ingredients. These plant-derived materials are commonly used in nail care products for their moisturizing and soothing properties. The patch is applied directly to the skin and is marketed under the FDA's OTC monograph rules for its product category. This product is intended for topical use only.

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.
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
84989-0016-01 You're viewing this Main listing 60 mg in 1 BOX 2026-01-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
XIMONTH Nail Repairs Patches .012 mg/60mg; .012 mg/60mg 84989-0015-01 Shantou 60 mg — — FDA listed —
Nail Repairs Patches .012 mg/60mg; .012 mg/60mgthis 84989-0016-01 Shantou 60 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

🏛️
2026
On the market since
Jan 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.

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.

  • 0.06 mg / 60 mg UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • 56.916 mg / 60 mg 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.
  • 3 mg / 60 mg 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.

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

The official label also statesAQUA、GLYCERIN、ALLANTOIN

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

LabelerShantou Ximonth Biotechnology Co., Ltd.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code84989
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio30 products on file

More NDCs from Shantou Ximonth Biotechnology Co., Ltd. labeler code 84989

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

1. Wash and dry affected nails before going to bed 2. Open the package, take out the patch and tear off the back film 3. Place the patch on the nail and remove it after about 6-8 hours

⏱️ Dosage and Administration 38 words ▾

1. Wash and dry affected nails before going to bed 2. Open the package, take out the patch and tear off the back film 3. Place the patch on the nail and remove it after about 6-8 hours

⚠️ Warnings 23 words ▾

Keep out of reach of children.Avoid contact with eyes.Discontinue use if signs of irritation or rash occur.Store in a cool and dry place.

📦 Storage and Handling 7 words ▾

Store in a cool and dry place.

🧪 Active Ingredient 6 words ▾

SOPHORA ANGUSTIFOLIA ROOT EXTRACT、ALOE BARBADENSIS EXTRACT

🧪 Inactive Ingredients 1 words ▾

AQUA、GLYCERIN、ALLANTOIN

🎯 Purpose 90 words ▾

1. A variety of moisturizing ingredients are absorbed into nails and skin through the patch, deeply nourishing, hydrating brittle nails, and reducing the appearance of thick and discolored nails. 2.

Replenish nails with necessary moisture and nutrients, quickly reduce brittle manicure overnight, and restore manicure to show its natural, healthy appearance. 3. Hygienic material support, soft and strong, can provide gentle repair to nails.

4. The packaging is compact and easy to use. The patch design is suitable for carrying when going out and can be used anytime and anywhere.

📄 Do Not Use 9 words ▾

Discontinue use if signs of irritation or rash occur.

📄 When Using This Product 38 words ▾

1. Wash and dry affected nails before going to bed 2. Open the package, take out the patch and tear off the back film 3. Place the patch on the nail and remove it after about 6-8 hours

📄 Stop Use and Ask a Doctor If 9 words ▾

Discontinue use if signs of irritation or rash occur.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Package Label / Principal Display Panel 1 words ▾

Label

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 Nail Repairs Patches (this brand).

Top reported reactions

Macular Degeneration598
Constipation440
Pain400
Nausea322
Pyrexia308
Malaise275
Weight Decreased268

Age at onset

Neonate3
Infant8
Child11
Adolescent7
Adult144
Elderly323

Reporter sex

2,561 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization1,397
Life-threatening282
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 470 116
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 Shantou Ximonth Biotechnology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Shantou Ximonth Biotechnology 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.
← 84989-0015-01 · Shantou 84989-0017-01 · Shantou →
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.