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Systane Balance propylene glycol .06 mg/mL Emulsion, 1 bottle — NDC 00065-1433-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Systane Balance propylene glycol .06 mg/mL Emulsion, 1 bottle — NDC 0065-1433-11 (Billing 00065-1433-11)

by Alcon Laboratories, Inc. · 1 BOTTLE, DROPPER in 1 CARTON / 1.5 mL in 1 BOTTLE, DROPPER

This is a package of 1 bottle of Systane Balance propylene glycol .06 mg/mL Emulsion from Alcon Laboratories, Inc., marketed since Jun 2010 and currently FDA-listed.

NDC 00065-1433-11
🏷️ FDA NDC (as labeled) 0065-1433-11 billing pads the labeler segment with a zero
This package
Contains1 bottle Pack sizes3 compare ↓
Product page 00065-1433-02 Also comes in: 10 mL 0065-1433-02 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) 0065-1433-11
Product NDC 0065-1433
11-digit billing NDC 00065143311
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
  • GSN (GCN sequence number): 066795
  • GCN: 29189
  • GPI-14 (Medi-Span): 86200060002015
  • HICL (First Databank): 003808
  • AHFS class code: 52:92.00.00
Why two NDCs? The FDA registers this code as 0065-1433-11 — 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 → 00065-1433-11. 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 mL 2 bottles
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 Main listing 1 BOTTLE, DROPPER in 1 CARTON / 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 / 10 mL in 1 BOTTLE, DROPPER $1.00 / mL $20.03 2010-06-25 — Active
00065-1433-11 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON / 1.5 mL in 1 BOTTLE, DROPPER — — 2010-06-25 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 1 bottle — 1 bottle, dropper in 1 carton / 1.5 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Systane Balance propylene glycol .06 mg/mL Emulsion?
Use the 11-digit billing form listed in the identifiers section of this page. 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 —
Systane COMPLETE PF .06 mg/mL 00065-1509-28 Alcon 1 bottle $1.347 — Availability likely —
Systane COMPLETE .06 mg/mL 00065-0481-01 Alcon 1 bottle — — FDA listed —
Systane Balance .06 mg/mLthis 00065-1433-11 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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 BI71WT9P3R
    A synthetic phospholipid (fat-like molecule) used as a surfactant and emulsifier in medicines. It helps stabilize and mix oil and water-based ingredients, and is commonly used in inhalation products and injectable 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 E89I1637KE
    Guar gum is a natural thickener made from guar bean seeds. It's used in medicines as a binder and thickening agent to hold ingredients together and create the right texture and consistency.
  • 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • 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 13A4J4NH9I
    A synthetic emulsifier derived from stearic acid and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid medicines and creams to create a smooth, uniform product.
  • 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 6LUM696811
    A waxy substance derived from sorbitol and stearic acid. It acts as an emulsifier and stabilizer to help mix oil and water components evenly throughout the medicine and prevent separation.
  • 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.

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

The official label also statesboric 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.

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 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 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 bottle00065-1433-02 94,811 Rx · $1,984,247
2 bottles00065-1433-07 7,784 Rx · $203,577
1 bottle this page00065-1433-11 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alcon Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (00065-1433-02), 2 bottles (00065-1433-07). Each has its own NDC and its own page — see the package list near the top of this page.
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.
← 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.