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Systane polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Gel, 10 mL — NDC 00065-0454-07 package photo

Systane polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Gel, 10 mL

by Alcon Laboratories, Inc. · 10 mL in 1 BOTTLE, DROPPER (0065-0454-07)
NDC 00065-0454-07
🏷️ FDA NDC (as labeled) 0065-0454-07 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

⚠️
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

FDA NDC (as labeled) 0065-0454-07
Product NDC 0065-0454
11-digit billing NDC 00065045407
NCPDP billing unit ML — per mL (volume)
RxCUI 895753
UNII B697894SGQ, 6DC9Q167V3
Application # M018
SPL Set ID 1d679d0f-cec2-a644-79cd-079607254bb9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-02-09
Route OPHTHALMIC
Dosage form GEL
Substance POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
GPI-14 86209902484020
GPI class Systane
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 SYSTANE GEL EYE DROPS
FDB brand name Systane Gel
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0065-0454-07 — 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 → 00065-0454-07. 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.

🏭 Manufacturer & labeler

LabelerAlcon Laboratories, Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code00065
First marketedFeb 2011
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.

🩺 Clinical

Label name SYSTANE GEL EYE DROPS Ingredient Propylene Glycol/Peg 400
🧪 What is this product?

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.

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.

🧪 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.

💲 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 $1.130 $11.30 / 10 ml
Medicaid paysCMS SDUD · 12 mo $1.79 $17.95 / 10 ml
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
Sep 2021 Nov 2022 Mar 2026 Aug 2026 $1.137 $1.007
▲ Up 12% over the last 15 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.

🔁 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 43%
GenTeal Tears Gel Drops 400 4 mg/mL; 3 mg/mL 00065-8067-01 Alcon 8 ml $1.075 — Availability likely save 5%
Systane 400 4 mg/mL; 3 mg/mLthis 00065-0454-07 Alcon 10 ml $1.130 — Availability likely —
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

🏛️
2011
On the market since
Feb 2011
📍
2026
Currently FDA-listed
15 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00065-0454-07, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4.7K
Units reimbursed last 4 qtrs
46K
Gross reimbursed last 4 qtrs
$82.6K
Avg / prescription
$17.76
Avg / unit
$1.7946
Latest quarter Q4 2025
985Rx
Medicaid pays / mL
$1.7946
gross reimbursed
vs
NADAC / mL
$1.1304
acquisition cost
=
Spread
+$0.6642
+59% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
41% FFS 59% MCO
Fee-for-service · 1,887 Rx Managed care · 2,763 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 6,123 units · 107 per 100k residents MN Wisconsin: 5,558 units · 94.0 per 100k residents WI Michigan: 1,820 units · 18.1 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 380 units · 11.9 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 990 units · 7.9 per 100k residents IL Indiana: 4,340 units · 63.2 per 100k residents IN Ohio: 8,220 units · 69.7 per 100k residents OH Pennsylvania: 3,190 units · 24.6 per 100k residents PA New Jersey: 3,733 units · 40.2 per 100k residents NJ Massachusetts: no data reported MA California: 5,950 units · 15.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 2,490 units · 126 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 1,060 units · 12.2 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 1,570 units · 21.1 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 490 units · 9.1 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 99 units · 0.4 per 100k residents FL
Units reimbursed · per 100k residents
0.4126
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nebraska 126 /100k
2 Minnesota 107 /100k
3 Wisconsin 94.0 /100k
4 Ohio 69.7 /100k
5 Indiana 63.2 /100k
6 New Jersey 40.2 /100k
7 Pennsylvania 24.6 /100k
8 Arizona 21.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00065-0454-07 You're viewing this 10 mL in 1 BOTTLE, DROPPER (0065-0454-07) 2011-02-11 Active

📄 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
🎯 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00065-0431-33 · Alcon 00065-0474-01 · 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.