Systane Ultra Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops
Other active recalls for Polyethylene Glycol 400 And Propylene Glycol (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Systane Ultra is an over-the-counter eye drop solution containing polyethylene glycol 400 and propylene glycol. These ingredients function as lubricants and are typically used to relieve dryness and irritation of the eye surface. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for lubricating eye drops rather than being individually reviewed.
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 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.
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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.
10 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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 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 | $0.552 | $16.57 / 30 ml |
| Medicaid paysCMS SDUD · 12 mo | $1.01 | $30.26 / 30 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?
🔁 Therapeutic equivalents
Where does this data come from?
⏳ 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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00065-1431-01 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-01) / 1.5 mL in 1 BOTTLE, DROPPER | — | — | 2014-10-01 | Active |
| 00065-1431-05 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-05) / 10 mL in 1 BOTTLE, DROPPER | $1.03 / mL | $10.30 | 2014-10-01 | Active |
| 00065-1431-18 You're viewing this | 3 BOTTLE, DROPPER in 1 CARTON (0065-1431-18) / 10 mL in 1 BOTTLE, DROPPER | $0.5522 / mL | $16.57 | 2014-10-01 | Active |
| 00065-1431-21 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-21) / 3 mL in 1 BOTTLE, DROPPER | $0.5887 / mL | $1.77 | 2014-10-01 | Active |
| 00065-1431-28 | 2 BOTTLE, DROPPER in 1 CARTON (0065-1431-28) / 4 mL in 1 BOTTLE, DROPPER | $1.09 / mL | $8.75 | 2014-10-01 | Active |
| 00065-1431-31 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-31) / 4 mL in 1 BOTTLE, DROPPER | — | — | 2014-10-01 | Active |
| 00065-1431-41 | 2 BOTTLE, DROPPER in 1 CARTON (0065-1431-41) / 10 mL in 1 BOTTLE, DROPPER | $0.8454 / mL | $16.91 | 2014-10-01 | Active |
| 00065-1431-80 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1431-80) / 3 mL in 1 BOTTLE, DROPPER | — | — | 2014-10-01 | Active |
This pack has the lowest per-mL cost of the 5 priced pack sizes ($0.5522 NADAC).
Pack size FAQ
What quantity is in NDC 00065-1431-18?
What NDC number is used to bill for this package of Systane Ultra Polyethylene Glycol 400 and Propylene 400 4 mg/mL; 3 mg/mL Solution/ Drops?
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.
📄 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 the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
⏱️ 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, hydroxypropyl guar, POLYQUAD® (polyquarternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, 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