Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
SYSTANE HYDRATION PF PRESERVATIVE FREE Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops, 5 vials — NDC 0065-1437-05 (Billing 00065-1437-05)
by Alcon Laboratories, Inc. · 5 VIAL, SINGLE-DOSE in 1 CARTON / .7 mL in 1 VIAL, SINGLE-DOSE
This is a package of 5 vials of SYSTANE HYDRATION PF PRESERVATIVE FREE Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops from Alcon Laboratories, Inc., marketed since Feb 2020 and currently FDA-listed.
NDC 00065-1437-05
🏷️ FDA NDC (as labeled)
0065-1437-05
billing pads the labeler segment with a zero
This package
Contains5 vials
Pack sizes2 compare ↓
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 0065-1437-05 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0065 labeler · 1437 product · 05 package
- Package marketed since
- Feb 1, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0065143705 8
- 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)
0065-1437-05
Product NDC
0065-1437
11-digit billing NDC
00065143705
RxCUI
477589
UNII
B697894SGQ, 6DC9Q167V3
Application #
M018
SPL Set ID
db3a6c68-320b-46b0-83fa-6c29297a84a6
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-02-01
Route
OPHTHALMIC
Dosage form
SOLUTION/ DROPS
Substance
POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
86209902482022
GPI class
Systane Hydration PF
GCN Seq No
058288
GCN
23696
HICL code
038529
Ingredient (HICL)
Propylene Glycol/Peg 400/Pf
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 HYDRATION PF 0.4-0.3%
FDB brand name
Systane Hydration Pf
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 058288
- GCN: 23696
- GPI-14 (Medi-Span): 86209902482022
- HICL (First Databank): 038529
- AHFS class code: 52:92.00.00
- RxCUI (RxNorm): 477589
Why two NDCs?
The FDA registers this code as 0065-1437-05 — 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 → 00065-1437-05. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Label name SYSTANE HYDRATION PF 0.4-0.3% Ingredient Propylene Glycol/Peg 400/Pf
🧪 What is this product?
Systane Hydration PF is an over-the-counter eye drop solution marketed as a preservative-free lubricant. It contains polyethylene glycol 400 and propylene glycol, which are humectant ingredients commonly used in artificial tear products to help lubricate and moisturize the eye surface. This type of product is typically used to relieve dryness and provide temporary comfort to dry or irritated eyes.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
💬 Questions about Polyethylene Glycol 400 and Propylene Glycol?
Ask a pharmacist →
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 | 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:
30 vials
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 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 | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00065-1437-04 0065-1437-04 Main listing | 30 VIAL, SINGLE-DOSE in 1 CARTON / .7 mL in 1 VIAL, SINGLE-DOSE | $0.3763 / ea | $11.29 | 2020-02-01 | — | Active |
| 00065-1437-05 You're viewing this | 5 VIAL, SINGLE-DOSE in 1 CARTON / .7 mL in 1 VIAL, SINGLE-DOSE | — | — | 2020-02-01 | — | 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 5 vials — 5 vial, single-dose in 1 carton / .7 ml in 1 vial, single-dose.
How does this package differ from NDC 00065-1437-04?
Both are SYSTANE HYDRATION PF PRESERVATIVE FREE Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops — the drug itself is identical. This page's package is the 5 vials one, while NDC 00065-1437-04 is the 30 vials package.
What NDC number is used to bill for this package of SYSTANE HYDRATION PF PRESERVATIVE FREE Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops?
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
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 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.
- 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.
-
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 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 YSE9PPT4TH
Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
-
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 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 91MBZ8H3QO
Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
-
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, hydroxypropyl guar, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate, sorbitol. 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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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 2020
Product typeHuman Otc Drug
Portfolio55 products on file
More NDCs from Alcon Laboratories, Inc. labeler code 00065
- BSS PLUS balanced salt solution enriched with bicarbonate, dextrose, and glutathione Kit NDC 0065-0800-50
- PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE 7 mg/mL Solution NDC 0065-0816-01
- atropine sulfate 10 mg/mL Solution NDC 0065-0817-01
- Systane Ultra Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-1431-01
- Systane ULTRA polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-1432-04
- Systane Balance propylene glycol .06 mg/mL Emulsion NDC 0065-1433-02
- Systane Day and Night Value Pack Polyethylene Glycol 400, Propylene Glycol 0.3% Kit NDC 0065-1502-10
- Systane Ultra Preservative Free Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-1507-82
- Systane COMPLETE PF propylene glycol .06 mg/mL Emulsion NDC 0065-1509-28
- SYSTANE HYDRATION PF PRESERVATIVE FREE Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops NDC 0065-1510-00
- Systane COMPLETE PF propylene glycol .06 mg/mL Emulsion NDC 0065-1530-01
- 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 0065-1795-04
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 ▾
Uses for use as a protectant against further irritation or to relieve dryness of the eye
⏱️ Dosage and Administration ▾
Directions 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, hydroxypropyl guar, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate, sorbitol. 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 do not reuse once opened, discard
📄 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 www.systane.com [email protected]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL SYSTANE ® Lubricant Eye Drops HYDRATION PF PRESERVATIVE-FREE DRY EYE RELIEF Convenient Single Vials On-the-Go Extra moisturizing for sensitive eyes Longer lasting hydration* VOTED PRODUCT OF THE YEAR Consumer Survey of Product Innovation 2021 ± Hydro Boost TECHNOLOGY Alcon STERILE 30 Vials 0.7 mL (0.02 FL OZ) Experience preservative-free relief that’s extra moisturizing for sensitive eyes Common Dry Eye Symptoms • Burning or stinging • Fluctuating vision • Irritation • Watery eyes TAMPER EVIDENT: For your protection, do not use if vial is damaged or opened at time of purchase.
1 Based on a survey of eye care professionals. Data on file. * vs SYSTANE ® ULTRA Lubricant Eye Drops ± Winner Eye Care Category. Survey of 40,000 people by Kantar. www.alconpatents.com Made in France 436272-0221 SYSTANE ® Lubricant Eye Drops HYDRATION PF PRESERVATIVE-FREE DRY EYE RELIEF DIRECTIONS: Make sure container is intact before use.
To open, COMPLETELY TWIST OFF TAB. Do not pull off. Put 1 or 2 drops in the affected eye(s) as needed.
Throw away container. Do not reuse. ALCON Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA LOT: EXP.:
No label section mentions that — try another word, or open the full label on DailyMed below.
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.
Drug total (last 4 qtrs): 4,285 Rx · 167,212 units · $127,209 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 1 other package presentation of this same product, including 30 vials (00065-1437-04). 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.
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.