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BION TEARS Dextran, Hypromellose 70 1 mg/mL; 2910 (4000 MPA.S) 3 mg/mL Solution/ Drops, 28 vials — NDC 00065-0419-18 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BION TEARS Dextran, Hypromellose 70 1 mg/mL; 2910 (4000 MPA.S) 3 mg/mL Solution/ Drops, 28 vials — NDC 0065-0419-18 (Billing 00065-0419-18)

by Alcon Laboratories, Inc. · 28 VIAL in 1 CARTON / .4 mL in 1 VIAL

This is a package of 28 vials of BION TEARS Dextran, Hypromellose 70 1 mg/mL; 2910 (4000 MPA.S) 3 mg/mL Solution/ Drops from Alcon Laboratories, Inc., no longer marketed (first marketed Oct 1992), no longer in the FDA NDC Directory; retail pharmacies pay about $0.4726 per vial (NADAC). It is this product's only package size.

NDC 00065-0419-18
🏷️ FDA NDC (as labeled) 0065-0419-18 billing pads the labeler segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 →

NDC database record

One package, one record: these facts belong to NDC 0065-0419-18 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0065 labeler · 0419 product · 18 package
Listing certified through
Dec 31, 2026
Billing quantity
28 EA per package
Barcode (UPC-A, from the NDC)
3 0065041918 5
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. 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) 0065-0419-18
Product NDC 0065-0419
11-digit billing NDC 00065041918
NCPDP billing unit EA — each (per item)
RxCUI 309714, 1088217
UNII 7SA290YK68, RN3152OP35
Application # M018
SPL Set ID e48d82f0-2f18-e514-4caa-e397d6713b99
Established class (EPC) Plasma Volume Expander
Mechanism of action Osmotic Activity
Physiologic effect Increased Intravascular Volume
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 1992-10-19
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86209902242025
GPI class Bion Tears PF
GCN Seq No 063562
GCN 99284
HICL code 036551
Ingredient (HICL) Dextran 70/Hypromellose/Pf
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6T
Therapeutic class — specific (HIC3) Artificial Tears
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name BION TEARS EYE DROP
FDB brand name Bion Tears
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 063562
  • GCN: 99284
  • GPI-14 (Medi-Span): 86209902242025
  • HICL (First Databank): 036551
  • AHFS class code: 52:92.00.00
  • RxCUI (RxNorm): 309714
Why two NDCs? The FDA registers this code as 0065-0419-18 — a 4-4-2 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 labeler segment → 00065-0419-18. 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 Viscoelastic substances class.

Drug family (ATC) Viscoelastic substances
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

Label name BION TEARS EYE DROP Ingredient Dextran 70/Hypromellose/Pf
🧪 What is this product?

Bion Tears is an over-the-counter eye drop solution containing dextran 70 and hypromellose, both ingredients commonly used to lubricate and protect the surface of the eye. These agents function as artificial tears, helping to relieve dryness and irritation by coating the eye and maintaining moisture. This is an OTC monograph product, meaning it is marketed under FDA's established category rules for over-the-counter eye lubricants rather than as an individually approved application.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.473 $13.23 / 28 vials
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.
NADAC price history (per ea) — tap or hover for the price & month
Sep 2022 Dec 2023 $0.473 $0.420
▲ Up 13% over the last 2 months.
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
00065-0419-18 You're viewing this Main listing 28 VIAL in 1 CARTON / .4 mL in 1 VIAL 2000-10-20 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
GenTeal Tears Moderate Preservative Free 2910 (4000 MPA.S) 3 mg/mL; 70 1 mg/mL 00065-8063-01 Alcon 36 vials $0.300 — Availability likely save 37%
Bion Tears 70 1 mg/mL; 2910 (4000 MPA.S) 3 mg/mL 00065-9305-01 Alcon 28 vials $0.473 — FDA listed —
Bion Tears 70 1 mg/mL; 2910 (4000 MPA.S) 3 mg/mLthis 00065-0419-18 Alcon 28 vials $0.473 — Discontinued —
Walgreens Lubricant Eye Drops Preservative Free 70 .1 g/100mL; .3 g/100mL 00363-0646-01 Walgreen 35 vials — — FDA listed —
CVS Gentle Tears .3 g/100mL; 70 .1 g/100mL 69842-0474-01 CVS 35 vials — — 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

🏛️
1992
On the market since
Oct 1992
📍
2026
Currently FDA-listed
34 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.

  • UNII M4I0D6VV5M
    Calcium chloride is a salt compound that acts as a firming agent and source of calcium ions in medications. It's used in formulations to help maintain tablet structure, improve texture, or serve as a buffering agent.
  • UNII 142M471B3J
    Carbon dioxide is a colorless gas used in medicines as a propellant in pressurized inhalers and aerosol sprays to help deliver the active medication to where it's needed.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • UNII 660YQ98I10
    Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.
  • UNII 86Q357L16B
    Zinc chloride is a mineral salt used as a buffer and pH regulator in medications. It helps maintain the chemical stability and proper acidity level of the drug formulation.

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

The official label also statesCalcium chloride, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride, zinc chloride, hydrochloric acid and/or sodium hydroxide and/or carbon dioxide to adjust pH.

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

LabelerAlcon Laboratories, Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code00065
First marketedOct 1992
Product typeHuman Otc Drug
Portfolio55 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 16 words ▾

Uses For use as a protectant against further irritation or to relieve dryness of the eye.

⏱️ Dosage and Administration 12 words ▾

Directions Instill 1 or 2 drops in the affected eye(s) as needed.

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 6 words ▾

Other Information Store at room temperature.

🧪 Active Ingredient 11 words ▾

Active Ingredients Purpose Dextran 70 0.1% Lubricant Hypromellose 2910 0.3% Lubricant

🧪 Inactive Ingredients 27 words ▾

Inactive Ingredients Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride, zinc chloride, hydrochloric acid and/or sodium hydroxide and/or carbon dioxide to adjust pH.

🎯 Purpose 11 words ▾

Active Ingredients Purpose Dextran 70 0.1% Lubricant Hypromellose 2910 0.3% Lubricant

📄 Do Not Use 21 words ▾

Do not use if this solution changes color or becomes cloudy. if you are sensitive to any ingredient in this product.

📄 When Using This Product 29 words ▾

When using this product To avoid contamination, do not touch tip of container to any surface. Do not touch unit-dose tip to eye. Do not reuse. Once opened, discard.

📄 Stop Use and Ask a Doctor If 29 words ▾

Stop use and ask a doctor if you experience eye pain changes in vision continued redness irritation of the eye symptoms worsening or persisting for more than 72 hours

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 7 words ▾

Questions? In the U.S. call 1-800-757-9195 www.tearsnaturale.com

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL Severe Dry Eye Preservative-Free BION ® TEARS LUBRICANT EYE DROPS 28 Single-Use Vials 0.4 ml (0.015 FL OZ) Each STERILE Alcon DIRECTIONS (HOW TO USE) Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB. Do not pull off.

Instill 1 or 2 drops in the affected eye(s) as needed. Throw away container. Do not reuse.

Once opened, discard. All four containers within a pouch must be used within four days of opening the pouch. Tamper Evident: Containers are sealed in a protective foil pouch.

Use only if foil pouch is undamaged at time of purchase. BION ® TEARS Lubricant Eye Drops is an advanced tear substitute especially formulated and packaged for persistent dry eye conditions requiring frequent therapy. MONEY BACK GUARANTEED To fully assess comfort, a 3 to 4-week trial of BION ® TEARS is recommended when switching from another brand of lubricant eye drops.

If, however, you are not satisfied with the comfort BION ® TEARS provides, we ask that you send the unused portion of the product and the sales receipt, with a brief description of why you were dissatisfied, to QA/Consumer Affairs, Alcon Laboratories, Fort Worth, TX 76134-2099. You will receive a full refund within 6 to 8 weeks. U.S.

Patent no. 5,403,598 © 2003, 2005, 2006, 2009, 2021 Alcon, Inc. Manufactured for: Alcon Alcon Laboratories, Inc.

Fort Worth, TX 76134-0109 Made in France 419199 Lot: Exp.:

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 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) ✓ Available
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.
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.
Who lists this product with the FDA?
Alcon Laboratories, Inc. 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.
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.