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Systane Balance propylene glycol .06 mg/mL Emulsion — NDC 0065-1433-02 (Billing 00065-1433-02) · Product 0065-1433

by Alcon Laboratories, Inc. · 1 BOTTLE, DROPPER in 1 CARTON (0065-1433-02) / 10 mL in 1 BOTTLE, DROPPER

NDC 0065-1433-02 (billing 00065-1433-02) is a package of Systane Balance propylene glycol .06 mg/mL Emulsion from Alcon Laboratories, Inc., marketed since Jun 2010 and currently FDA-listed; retail pharmacies pay about $1.17 per mL (NADAC). It is the main listing for product NDC 0065-1433, which comes in 3 package sizes.

NDC 00065-1433-02
🏷️ FDA NDC (as labeled) 0065-1433-02 billing pads the labeler segment with a zero
This package
Contains10 mL in 1 bottle, dropper Cost per mL$1.17 NADAC Per package$11.68 / 10 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $1.83/unit — full pricing hub ↓
Main listing for product 0065-1433 · Also comes in: 1.5 mL 0065-1433-11 2 bottles 0065-1433-07
OTC On market Non-controlled ⇄ 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 →

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 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 · Dec 31, 2025 — Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. (Wizcure Pharmaa Private Limited) · FDA recall D-0348-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class II · Jun 29, 2022 · Terminated — CGMP Deviations: products were stored outside the drug label specifications. (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1316-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0065-1433-02
Product NDC 0065-1433
11-digit billing NDC 00065143302
NCPDP billing unit ML — per mL (volume)
UNII 6DC9Q167V3
Application # M018
SPL Set ID c7b1a03a-a5f2-409e-a34a-d6f166671de5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-06-25
Route OPHTHALMIC
Dosage form EMULSION
Substance PROPYLENE GLYCOL

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

GPI-14 86200060002015
GPI class Systane Balance
GCN Seq No 066795
GCN 29189
HICL code 003808
Ingredient (HICL) Propylene Glycol
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 BALANCE 0.6% EYE DROP
FDB brand name Systane Balance
Legend status O — Over-the-counter (OTC) drug or device
Quick answers for NDC 0065-1433-02
  • GSN (GCN sequence number): 066795
  • GCN: 29189
  • GPI-14 (Medi-Span): 86200060002015
  • HICL (First Databank): 003808
  • AHFS class code: 52:92.00.00
  • 11-digit billing NDC: 00065143302
Why two NDCs? The FDA registers this code as 0065-1433-02 — 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 → 00065-1433-02. 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 SYSTANE BALANCE 0.6% EYE DROP Ingredient Propylene Glycol
🧪 What is this product?

Systane Balance is an over-the-counter eye emulsion containing propylene glycol, an ingredient that is typically used to lubricate and moisturize the surface of the eye. This product is applied directly to the eye and falls under the FDA's OTC monograph category for lubricating eye drops, meaning it is marketed under a general set of rules for this class of product rather than as an individually approved medication. Propylene glycol is a common component in artificial tear formulations meant to help manage dry eye discomfort.

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 $1.168 $11.68 / 10 ml
Medicaid paysCMS SDUD · 12 mo $1.83 $18.34 / 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
Nov 2021 Feb 2024 Apr 2026 Sep 2026 $1.169 $1.005
▲ Up 13% over the last 16 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 Per unit Per pack Marketing startMarketing endStatus
00065-1433-02 0065-1433-02 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON (0065-1433-02) / 10 mL in 1 BOTTLE, DROPPER $1.17 / mL $11.68 2010-06-25 — Active
00065-1433-07 0065-1433-07 2 BOTTLE, DROPPER in 1 CARTON (0065-1433-07) / 10 mL in 1 BOTTLE, DROPPER $1.00 / mL $20.03 2010-06-25 — Active
00065-1433-11 0065-1433-11 1 BOTTLE, DROPPER in 1 CARTON (0065-1433-11) / 1.5 mL in 1 BOTTLE, DROPPER — — 2010-06-25 — Active

Per mL, this pack runs about 17% above the cheapest pack (NDC 00065-1433-07, $1.00 vs $1.17 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 92% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00065-1433-02?
NDC 00065-1433-02 is listed by the FDA — 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Systane Balance propylene glycol .06 mg/mL Emulsion?
Bill NDC 00065-1433-02 — the 11-digit billing format is 00065143302. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Restorative Formula Lubricant Eye Drops .6 g/100mL 70000-0013-01 Cardinal 1 bottle $0.214 — Availability likely save 82%
Systane Balance .06 mg/mLthis 00065-1433-02 Alcon 1 bottle $1.168 — Availability likely —
Systane COMPLETE PF .06 mg/mL 00065-1509-28 Alcon 1 bottle $1.347 — Availability likely +15%
Systane COMPLETE .06 mg/mL 00065-0481-01 Alcon 1 bottle — — FDA listed —
Systane COMPLETE PF .06 mg/mL 00065-1530-01 Alcon 5 vials — — FDA listed —
OneDrop .6 g/100mL 57619-0306-01 LABORATORIOS 1 bottle — — 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

🏛️
2010
On the market since
Jun 2010
📍
2026
Currently FDA-listed
16 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 marketedJun 2010
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 ⏱️ 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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

Uses for the temporary relief of burning and irritation due to dryness of the eye for use as a lubricant to prevent further irritation or to relive 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 97 words ▾

Warnings For external use only Do not use if this product changes color if you are sensitive to any ingredient in 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 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. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 7 words ▾

Active Ingredient Purpose Propylene Glycol 0.6% Lubricant

🧪 Inactive Ingredients 36 words ▾

Inactive ingredients: boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD ® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

🎯 Purpose 7 words ▾

Active Ingredient Purpose Propylene Glycol 0.6% Lubricant

📄 Do Not Use 18 words ▾

Do not use if this product changes color 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.

📄 Questions or Comments 8 words ▾

Questions: In the U.S. call 1-800-757-9195 [email protected] www.systane.com

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL Systane ® LUBRICANT EYE DROPS BALANCE Restoring Dry Eye Relief Locks in moisture Tear evaporation protection Clinically proven DOCTOR RECOMMENDED #1 BRAND 1 Alcon STERILE 10 mL (1/3 FL OZ) LOT: EXP.: 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 Systane ® BALANCE Lubricant Eye Drops restores the natural tear’s lipid layer to lock in moisture and protect against tear evaporation.

ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 1 Based on a survey of eye care professionals. Data on file.

300048644-0521

PRINCIPAL DISPLAY PANEL TWIN PACK Systane ® LUBRICANT EYE DROPS BALANCE Restoring Dry Eye Relief Locks in moisture Tear evaporation protection Clinically proven DOCTOR RECOMMENDED #1 BRAND 1 Alcon STERILE Two 10 mL (1/3 FL OZ) Bottles LOT: EXP.: 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 Systane ® BALANCE Lubricant Eye Drops restores the natural tear’s lipid layer to lock in moisture and protect against tear evaporation.

ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 1 Based on a survey of eye care professionals. Data on file.

300037158-0420 Systane ® LUBRICANT EYE DROPS BALANCE Restoring Dry Eye Relief Lipid Rich Formula Tear evaporation protection DOCTOR RECOMMENDED #1 BRANDS 1 Alcon STERILE 10 mL (1/3 fl oz) LOT: EXP.: 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 Systane ® BALANCE Lubricant Eye Drops restores the natural tear’s lipid layer to lock in moisture and protect against tear evaporation.

ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 1 Based on a survey of eye care professionals. Data on file.

300072016-0525

PRINCIPAL DISPLAY PANEL Systane ® LUBRICANT EYE DROPS BALANCE Restoring Dry Eye Relief STERILE 10 mL (1/3 FL OZ) INGREDIENTS: Active: Propylene Glycol 0.6%. Inactives: Boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD ® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Store at room temperature. FOR EXTERNAL USE ONLY USES : See carton for USES. WARNINGS : See carton for WARNINGS.

DIRECTIONS : Shake well and put 1 or 2 drops in the affected eye(s) as needed. Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 300060319-0223

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

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 00065-1433-02, 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 – Q1 2026 · 5 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
94.8K
Units reimbursed last 4 qtrs
1.1M
Gross reimbursed last 4 qtrs
$1.98M
Avg / prescription
$20.93
Avg / unit
$1.8339
Latest quarter Q1 2026
8.3KRx
Medicaid pays / mL
$1.8339
gross reimbursed
vs
NADAC / mL
$1.1675
acquisition cost
=
Spread
+$0.6664
+57% 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 ⓘ
95% FFS
Fee-for-service · 90,148 Rx Managed care · 4,663 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: 16,040 units · 280 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 306,611 units · 1,567 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 900 units · 28.2 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 4,260 units · 62.1 per 100k residents IN Ohio: no data reported OH Pennsylvania: 1,830 units · 14.1 per 100k residents PA New Jersey: 1,880 units · 20.2 per 100k residents NJ Massachusetts: no data reported MA California: 743,972 units · 1,909 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 2,285 units · 116 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 775 units · 8.9 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 1,605 units · 21.6 per 100k residents AZ New Mexico: 1,400 units · 66.2 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 440 units · 8.2 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: no data reported FL
Units reimbursed · per 100k residents
8.21,909
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 California 1,909 /100k
2 New York 1,567 /100k
3 Minnesota 280 /100k
4 Nebraska 116 /100k
5 New Mexico 66.2 /100k
6 Indiana 62.1 /100k
7 Nevada 28.2 /100k
8 Arizona 21.6 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page00065-1433-02 94,811 Rx · $1,984,247
2 bottles00065-1433-07 7,784 Rx · $203,577
1 bottle00065-1433-11 No Medicaid data
Drug total (last 4 qtrs): 102,595 Rx · 1,234,422 units · $2,187,823 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 00065-1432-04 · Alcon 00065-1437-04 · 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.