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Eye CareSpray Eyelid Cleansing Spray .001 U/100mL; 4-TERPINEOL .002 U/100mL Solution — NDC 43116-051-03 (Billing 43116-0051-03)

by Shenzhen Shierjie Biological Engineering Co., LTD · 2 POUCH in 1 CARTON / 1 BOTTLE in 1 POUCH / 50 mL in 1 BOTTLE

This is a package of Eye CareSpray Eyelid Cleansing Spray .001 U/100mL; 4-TERPINEOL .002 U/100mL Solution from Shenzhen Shierjie Biological Engineering Co., LTD, marketed since May 2026 and currently FDA-listed. It is this product's only package size.

NDC 43116-0051-03
🏷️ FDA NDC (as labeled) 43116-051-03 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43116-051-03
Product NDC 43116-051
11-digit billing NDC 43116005103
UNII VIF565UC2G, L65MV77ZG6
Application # M005
SPL Set ID 52aef5dd-ff33-cace-e063-6294a90a415a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-26
Route OPHTHALMIC
Dosage form SOLUTION
Substance MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL; 4-TERPINEOL
Why two NDCs? The FDA registers this code as 43116-051-03 — 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 → 43116-0051-03. 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?

This is an over-the-counter ophthalmic spray solution marketed under FDA's monograph rules for eyelid and eye-area cleansing products. It contains tea tree leaf oil and 4-terpineol, both ingredients commonly included in cleansing formulations for their antimicrobial and soothing properties. The spray form is designed for topical application around the eyelids to help cleanse the eye area as part of routine hygiene or eye-care routines.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43116-0051-03 You're viewing this Main listing 2 POUCH in 1 CARTON / 1 BOTTLE in 1 POUCH / 50 mL in 1 BOTTLE 2026-05-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eye CareSpray .001 U/100mL; 4-TERPINEOL .002 U/100mLthis 43116-0051-03 Shenzhen 2 pouches — — 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
May 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.

  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII P6YC3EG204
    Cyanocobalamin is a synthetic form of vitamin B12. It's used in medicines as a nutritional ingredient and to help maintain the product's stability and potency over time.
  • 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 X72A60C9MT
    Lutein is a yellow-orange plant pigment from marigold flowers or synthesized chemically. It's used as a colorant to give medicines their yellow or orange appearance.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 1EQV5MLY3D
    Taurine is a naturally occurring amino acid compound. In medicines, it may function as a stabilizer or buffering agent to help maintain the product's chemical balance and shelf stability.
  • 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.

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

The official label also statesWater, Phenoxyethanol, Glycerin, Aloe Barbadensis Leaf Extract, XanthophyIl, Taurine, Cyanocobalamin, Sodium Hyaluronate

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

LabelerShenzhen Shierjie Biological Engineering Co., LTD
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code43116
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio17 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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

Use Gently refreshes and hydrates the eye area. Helps soothe dry, tired eyes and remove surface impurities-leaving skin around the eyes feeling clean, comfortable, and moisturized.

⏱️ Dosage and Administration 47 words ▾

Directions .Wash your hands & clean the eye area; Spray on each closed eye or a clean wipe, 2~3times; Wipe gently with a clean cloth to dry along the base of both lash line. ·Children under 6 years of age should be surpervised when using this product.

⚠️ Warnings 35 words ▾

Warnings .For external use only. ·This product is for daily use only and does not have disease prevention or treatment functions. It cannot be used as a substitute for medicines, health care products, cosmetics, etc.

📦 Storage and Handling 21 words ▾

Other information ·Store below 77°F/25℃. ·Store in a cool, dry place, protected from the direct sunlight. ·Validity period for 3 years.

🧪 Active Ingredient 9 words ▾

Active Ingredient 4-Terpineol0.002% Melaleuca Alternifolia (Tea Tree) Leaf Oil0.001%.

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients Water, Phenoxyethanol, Glycerin, Aloe Barbadensis Leaf Extract, XanthophyIl, Taurine, Cyanocobalamin, Sodium Hyaluronate

🎯 Purpose 2 words ▾

Purpose Antibacterial

📄 Do Not Use 20 words ▾

Do not use People with allergic constitution, those with rashes or open wounds around the eyes are prohibited from using.

📄 When Using This Product 21 words ▾

When Using When using this product, please remove contact lenses before use. In case of uncomfortable contact, rinse thoroughly with water.

📄 Stop Use and Ask a Doctor If 23 words ▾

Stop Use Stop application if eyes or skin around eyes show signs of redness, irritation or sensitivity and consult your eye care professional.

📄 Keep Out of Reach of Children 25 words ▾

Keep Oot Of Reach Of Children To avoid the risk of choking and suffocation, keep bottle and plastic bag away from babies, children and pets.

📄 Package Label / Principal Display Panel 6 words ▾

PRINCIPAL DISPLAY PANEL undefined undefined undefined

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

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 — Not published for this NDC No photo available yet for this listing.
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 Shenzhen Shierjie Biological Engineering Co., LTD. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Shenzhen Shierjie Biological Engineering 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.
← 43116-0050-01 · Shenzhen 43128-0001-08 · NDC, →
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.