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FreshKote Preservative Free Lubricant Eye Drops Povidone, Polyvinyl Alcohol 20 g/1000mL; 27 g/1000mL Solution — NDC 71776-0001-10 package photo

FreshKote Preservative Free Lubricant Eye Drops Povidone, Polyvinyl Alcohol 20 g/1000mL; 27 g/1000mL Solution

by Eyevance Pharmaceuticals · 1 BOTTLE, DROPPER in 1 BOX (71776-001-10) / 10 mL in 1 BOTTLE, DROPPER
NDC 71776-0001-10
🏷️ FDA NDC (as labeled) 71776-001-10 billing pads the product segment with a zero
This package
Contains10 mL in 1 bottle, dropper Cost per mL$2.88 NADAC Per package$28.81 / 10 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $3.05/unit — full pricing hub ↓
Also comes in: 30 vials 71776-0001-03
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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

🆔 Identity & classification

FDA NDC (as labeled) 71776-001-10
Product NDC 71776-001
11-digit billing NDC 71776000110
NCPDP billing unit ML — per mL (volume)
RxCUI 630977, 630981
UNII FZ989GH94E, 532B59J990
Application # M018
SPL Set ID f51c50c3-43ae-4169-9d2b-22b239461dd1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-03-13
Route OPHTHALMIC
Dosage form SOLUTION
Substance POVIDONE; POLYVINYL ALCOHOL, UNSPECIFIED
GPI-14 86209902502042
GPI class FreshKote PF
GCN Seq No 061694
GCN 97480
HICL code 003500
Ingredient (HICL) Polyvinyl Alcohol/Povidone
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 FRESHKOTE EYE DROP
FDB brand name Freshkote
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 71776-001-10 — a 5-3-2 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 product segment → 71776-0001-10. 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

LabelerEyevance Pharmaceuticals
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code71776
First marketedMar 2019
Product typeHuman Otc Drug
Portfolio2 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 FRESHKOTE EYE DROP Ingredient Polyvinyl Alcohol/Povidone
🧪 What is this product?

FreshKote Preservative Free Lubricant Eye Drops is an over-the-counter eye solution containing polyvinyl alcohol and povidone as active ingredients. Both of these substances function as lubricants and are typically used to coat and soothe the eye surface. This product is marketed under FDA's OTC monograph rules for lubricating eye drops, a category intended to relieve dryness and irritation. The solution is applied directly to the eye as needed.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 1Z74184RGV
    Egg phospholipids are naturally derived fats from eggs that help mix oil and water-based ingredients together. They work as emulsifiers in medicines, keeping the formula stable and uniform.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 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.

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

The official label also statesInactive ingredients Boric acid, Edetate disodium, Ethanol, Glycerin, Phospholipids, Polysorbate 80, Potassium chloride, Purified water, Sodium chloride.  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 $2.881 $28.81 / 10 ml
Medicaid paysCMS SDUD · 12 mo $3.05 $30.49 / 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 2025 $2.881 $2.881
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
FreshKote Preservative Free Lubricant Eye Drops 20 g/1000mL; 27 g/1000mLthis 71776-0001-10 Eyevance 1 bottle $2.881 — Availability likely —
Freshkote Preservative Free Lubricant Eye Drops 27 g/1000mL; 20 g/1000mL 82667-0013-10 Harrow 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

🏛️
2019
On the market since
Mar 2019
📍
2026
Currently FDA-listed
7 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 71776-0001-10, 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
621
Units reimbursed last 4 qtrs
6.3K
Gross reimbursed last 4 qtrs
$19.1K
Avg / prescription
$30.73
Avg / unit
$3.0485
Latest quarter Q4 2025
23Rx
Medicaid pays / mL
$3.0485
gross reimbursed
vs
NADAC / mL
$2.8810
acquisition cost
=
Spread
+$0.1675
+6% 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 ⓘ
59% FFS 41% MCO
Fee-for-service · 368 Rx Managed care · 253 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: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,100 units · 5.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 2,500 units · 26.9 per 100k residents NJ Massachusetts: no data reported MA California: 1,770 units · 4.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 890 units · 24.6 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported 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: no data reported 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
4.526.9
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 New Jersey 26.9 /100k
2 Connecticut 24.6 /100k
3 New York 5.6 /100k
4 California 4.5 /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 page71776-0001-10 621 Rx · $19,084
30 vials71776-0001-03 No Medicaid data
Drug total (last 4 qtrs): 621 Rx · 6,260 units · $19,084 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
71776-0001-03 30 VIAL, SINGLE-USE in 1 BOX (71776-001-03) / .3 mL in 1 VIAL, SINGLE-USE — — 2020-12-06 Active
71776-0001-10 You're viewing this 1 BOTTLE, DROPPER in 1 BOX (71776-001-10) / 10 mL in 1 BOTTLE, DROPPER $2.88 / mL $28.81 2019-03-13 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 71776-0001-10?
NDC 71776-0001-10 is listed by the FDA — 1 bottle, dropper in 1 box / 10 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of FreshKote Preservative Free Lubricant Eye Drops Povidone, Polyvinyl Alcohol 20 g/1000mL; 27 g/1000mL Solution?
Bill NDC 71776-0001-10 — the 11-digit billing format is 71776000110. 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.

📄 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 17 words ▾

Uses For use as a lubricant to reduce further irritation or to relieve dryness of the eye

⏱️ Dosage and Administration 12 words ▾

Directions Instill 1 or 2 drop(s) in the affected eye(s) as needed

⚠️ Warnings 5 words ▾

Warnings For external use only.

📦 Storage and Handling 27 words ▾

Other information Use before expiration date and discard bottle 30 days after opening Store at 20-25 ο C(68-77 ο F) Retain carton for reference Do not freeze

🧪 Active Ingredient 8 words ▾

Active Ingredients Purpose Polyvinyl Alcohol 2.7%.........Lubricant Povidone 2.0%....................Lubricant

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients Boric acid, Edetate disodium, Ethanol, Glycerin, Phospholipids, Polysorbate 80, Potassium chloride, Purified water, Sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

🎯 Purpose 21 words ▾

Purpose For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71773-0100-12 · Tetraphase 71776-0005-15 · Eyevance →
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.