Systane polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Gel, 10 mL — NDC 0065-0454-07 (Billing 00065-0454-07)
This is a package of 10 mL of Systane polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Gel from Alcon Laboratories, Inc., marketed since Feb 2011 and currently FDA-listed; retail pharmacies pay about $1.13 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0065-0454-07 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0065 labeler · 0454 product · 07 package
- Package marketed since
- Feb 11, 2011
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 10 mL per package
- Barcode (UPC-A, from the NDC)
- 3 0065045407 0
- Medicaid fills, this package
- 4,663 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Polyethylene Glycol 400 And Propylene Glycol (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- 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
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Systane GEL is an over-the-counter eye lubricant gel marketed under FDA's OTC monograph rules. It contains polyethylene glycol 400 and propylene glycol, which are lubricating agents commonly used to relieve dry eye symptoms and protect the eye surface. These ingredients function as artificial tears, helping to moisturize and soothe irritated eyes when applied directly to the eye.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $1.130 | $11.30 / 10 ml |
| Medicaid paysCMS SDUD · 12 mo | $1.76 | $17.61 / 10 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00065-0454-07 You're viewing this Main listing | 10 mL in 1 BOTTLE, DROPPER | 2011-02-11 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dry eye relief 400 4 mg/mL; 3 mg/mL 70000-0088-01 | CARDINAL | 10 ml | $0.648 | — | FDA listed | save 43% |
| GenTeal Tears Gel Drops 400 4 mg/mL; 3 mg/mL 00065-8067-01 | Alcon | 8 ml | $1.090 | — | Availability likely | save 4% |
| Systane 400 4 mg/mL; 3 mg/mLthis 00065-0454-07 | Alcon | 10 ml | $1.130 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Alcon Laboratories, Inc. labeler code 00065
- Alcon Tears Lubricant Eye Drops hypromellose 2910 2910 (4000 MPA.S) 5 mg/mL Solution/ Drops NDC 0065-0408-72
- Betadine povidone-iodine 5 mg/mL Solution NDC 0065-0411-30
- BION TEARS Dextran, Hypromellose 70 1 mg/mL; 2910 (4000 MPA.S) 3 mg/mL Solution/ Drops NDC 0065-0419-18
- GenTeal Tears (Moderate) Dextran 70, Glycerin, Hypromellose 70 1 mg/mL; 2 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-0426-36
- Systane Lubricant polyethylene glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-0429-15
- Systane polyethylene glycol and propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-0431-33
- Systane hypromellose 2910 (4000 MPA.S) 3 mg/g Gel NDC 0065-0474-01
- Systane COMPLETE propylene glycol .06 mg/mL Emulsion NDC 0065-0481-01
- Systane Nighttime mineral oil and white petrolatum 30 mg/g; 940 mg/g Ointment NDC 0065-0509-35
- GenTeal Tears NIGHT-TIME mineral oil, white petrolatum .03 g/g; .94 g/g Ointment NDC 0065-0518-01
- Tetracaine Hydrochloride 5 mg/mL Solution NDC 0065-0741-14
- BSS balanced salt solution 6.4 mg/mL; .75 mg/mL; .48 mg/mL; .3 mg/mL; 3.9 mg/mL; 1.7 mg/mL Solution NDC 0065-0795-15
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
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 ▾
Directions shake well before using put 1 or 2 drops in the affected eye(s) as needed
⚠️ Warnings ▾
Warnings For external use only
🧪 Active Ingredient ▾
Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant
🧪 Inactive Ingredients ▾
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 ▾
Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant
📄 Do Not Use ▾
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 ▾
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 ▾
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 ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Other Information ▾
Other information store at room temperature
📄 Questions or Comments ▾
Questions? In the U.S. call 1-800-757-9195 [email protected] www.systane.com
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL Systane ® LUBRICANT EYE GEL GEL DROPS SOOTHING DRY EYE RELIEF Long-lasting formula Day or night protection #1 DOCTOR RECOMMENDED BRAND 1 LIQUID GEL STERILE 10mL (1/3 FL OZ) Alcon SIDE PANEL TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. www.alconpatents.com Made in USA from domestic and imported materials Indulge your eyes in this easy-to-use droppable gel. Systane ® GEL DROPS forms a protective shield over your eyes to provide enduring relief day or night.
1 Based on a survey of eye care professionals. Data on file. 300048642-0621 Alcon Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA Systane ® LUBRICANT EYE GEL GEL DROPS SOOTHING DRY EYE RELIEF Long-lasting formula Day or night protection #1 DOCTOR RECOMMENDED BRANDS1 LIQUID GEL STERILE 10mL (1/3 fl oz) Alcon SIDE PANEL TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. www.alconpatents.com Country of Origin: Singapore Indulge your eyes in this easy-to-use droppable gel. Systane® GEL DROPS forms a protective shield over your eyes to provide enduring relief day or night.
ACTUAL SIZE 1 Based on a survey of eye care professionals. Data on file. Alcon Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA 300072079-0525