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GenTeal Tears Gel Drops polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Gel, 8 mL — NDC 00065-8067-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

GenTeal Tears Gel Drops polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Gel, 8 mL — NDC 0065-8067-01 (Billing 00065-8067-01)

by Alcon Laboratories, Inc. · 8 mL in 1 BOTTLE, DROPPER

This is a package of 8 mL of GenTeal Tears Gel Drops polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Gel from Alcon Laboratories, Inc., marketed since Feb 2021 and currently FDA-listed; retail pharmacies pay about $1.09 per mL (NADAC). It is this product's only package size.

NDC 00065-8067-01
🏷️ FDA NDC (as labeled) 0065-8067-01 billing pads the labeler 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 0065-8067-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0065 labeler · 8067 product · 01 package
Package marketed since
Feb 4, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
8 mL per package
Barcode (UPC-A, from the NDC)
3 0065806701 2
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Polyethylene Glycol 400 And Propylene Glycol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 23, 2025 — cGMP deviations and lack of assurance of sterility. (BRS Analytical Services, LLC) · FDA recall D-0407-2025
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) 0065-8067-01
Product NDC 0065-8067
11-digit billing NDC 00065806701
NCPDP billing unit ML — per mL (volume)
RxCUI 895753
UNII B697894SGQ, 6DC9Q167V3
Application # M018
SPL Set ID 84388a75-9d11-48ce-bf5a-88f0580d2d03
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-02-04
Route OPHTHALMIC
Dosage form GEL
Substance POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL

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

GPI-14 86209902484020
GPI class GenTeal Tears Severe Day/Night
GCN Seq No 067277
GCN 29804
HICL code 025225
Ingredient (HICL) Propylene Glycol/Peg 400
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 GENTEAL TEARS SEVERE GEL DROPS
FDB brand name Genteal Tears Severe
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 067277
  • GCN: 29804
  • GPI-14 (Medi-Span): 86209902484020
  • HICL (First Databank): 025225
  • AHFS class code: 52:92.00.00
  • RxCUI (RxNorm): 895753
Why two NDCs? The FDA registers this code as 0065-8067-01 — 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 → 00065-8067-01. 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

Label name GENTEAL TEARS SEVERE GEL DROPS Ingredient Propylene Glycol/Peg 400
🧪 What is this product?

GenTeal Tears Gel Drops is an over-the-counter eye gel containing polyethylene glycol 400 and propylene glycol. Both ingredients are lubricants commonly used in eye drops and gels to help soothe and moisturize the surface of the eye. This product is applied directly to the eye and is typically used to relieve dryness and irritation. It is marketed as an OTC monograph drug, meaning it follows FDA's established standards for this category of eye lubricants.

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 $1.090 $8.72 / 8 ml
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 mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $1.142 $1.075
▼ Down 5% over the last 9 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
00065-8067-01 You're viewing this Main listing 8 mL in 1 BOTTLE, DROPPER 2021-02-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dry eye relief 400 4 mg/mL; 3 mg/mL 70000-0088-01 CARDINAL 10 ml $0.648 — FDA listed save 41%
GenTeal Tears Gel Drops 400 4 mg/mL; 3 mg/mLthis 00065-8067-01 Alcon 8 ml $1.090 — Availability likely —
Systane 400 4 mg/mL; 3 mg/mL 00065-0454-07 Alcon 10 ml $1.130 — Availability likely +4%
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

🏛️
2021
On the market since
Feb 2021
📍
2026
Currently FDA-listed
5 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 LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 3A1I7376TC
    A natural gum derived from guar seeds, used as a thickener and binder in medicines. It increases viscosity to improve texture and help hold ingredients together in liquid or semi-solid formulations.
  • 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 6716Z5YR3G
    A synthetic polymer compound used as an antimicrobial preservative and stabilizer in pharmaceutical formulations. It helps prevent microbial growth and maintain product 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 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statesAminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and /or sodium hydroxide 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 marketedFeb 2021
Product typeHuman Otc Drug
Portfolio55 products on file

More NDCs from Alcon Laboratories, Inc. labeler code 00065

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 🧪 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

Uses for the temporary relief of burning and irritation due to dryness of the eye for use as a protectant against further irritation or to relieve dryness of the eye

⏱️ Dosage and Administration 16 words ▾

Directions shake well before using put 1 or 2 drops in the affected eye(s) as needed

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 12 words ▾

Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and /or sodium hydroxide to adjust pH.

🎯 Purpose 12 words ▾

Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant

📄 Do Not Use 21 words ▾

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

📄 When Using This Product 21 words ▾

When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use

📄 Stop Use and Ask a Doctor If 34 words ▾

Stop use and ask a doctor if you experience any of the following: eye pain changes in vision continued redness or irritation of the eye condition worsens or persists 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.

📄 Other Information 6 words ▾

Other information store at room temperature

📄 Questions or Comments 46 words ▾

Questions? In the U.S. call 1-800-757-9195 [email protected] www.genteal.com Alcon Laboratories Inc. Fort Worth, TX 76134 USA Made in the USA from domestic and imported materials 300038472-0920 TOP OF THE CARTON GenTeal ® Tears LUBRICANT EYE DROPS Severe Day + Night DRY EYE SYMPTOM RELIEF GEL DROPS

📄 Package Label / Principal Display Panel 87 words ▾

PRINCIPAL DISPLAY PANEL Severe Day + Night DRY EYE SYMPTOM RELIEF GEL DROPS GenTeaL ® Tears LUBRICANT EYE DROPS GEL DROPS Strength of a Gel, Convenience of a drop STERILE Alcon 8ml (0.3 FL OZ) TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase. GENTEAL ® TEARS Gel Drops contains two lubricants to deliver the relief of a gel with the comfort and convenience of a drop.

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 GenTeal Tears Gel Drops (this brand).

Top reported reactions

Eye Irritation1
Eye Pain1
Eye Pruritus1
Intraocular Pressure Increased1
Ocular Hyperaemia1
Product Container Issue1
Vision Blurred1

Reporter sex

4 reports
Male · 25%
Female · 75%
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.
← 00065-8064-01 · Alcon 00065-8150-01 · Alcon →
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.