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iVIZIA Dry Eye povidone 25 mg/5mL Solution/ Drops — NDC 82584-0700-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

iVIZIA Dry Eye povidone 25 mg/5mL Solution/ Drops — NDC 82584-700-11 (Billing 82584-0700-11)

by Thea Pharma Inc. · 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

This is a package of iVIZIA Dry Eye povidone 25 mg/5mL Solution/ Drops from Thea Pharma Inc., marketed since Dec 2024 and currently FDA-listed.

NDC 82584-0700-11
🏷️ FDA NDC (as labeled) 82584-700-11 billing pads the product segment with a zero
This package
Contains10 mL in 1 bottle, dropper Pack sizes3 compare ↓
Product page 82584-0700-05 Also comes in: 5 mL 82584-700-05 5 mL 82584-700-13
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

NDC database record

One package, one record: these facts belong to NDC 82584-700-11 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82584 labeler · 700 product · 11 package
Package marketed since
Dec 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8258470011 9
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · Apr 23, 2026 — Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. (Thea Pharma, Inc.) · FDA recall D-0500-2026
Lots / codes: Lot#: 3T36B, Exp. Date October 31, 2026. · reported May 6, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82584-700-11
Product NDC 82584-700
11-digit billing NDC 82584070011
NCPDP billing unit ML — per mL (volume)
RxCUI 2570860, 2586186
UNII FZ989GH94E
Application # M018
SPL Set ID 1ef73cb1-da48-a713-e063-6294a90afa9d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance POVIDONE
Quick answers
  • RxCUI (RxNorm): 2570860
Why two NDCs? The FDA registers this code as 82584-700-11 — 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 → 82584-0700-11. 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

🧪 What is this product?

iVIZIA Dry Eye is an over-the-counter eye drop solution containing povidone, a lubricating agent. This product is an OTC monograph drug, meaning it is marketed under FDA's established rules for this category rather than as an individually approved application. Povidone is commonly used in eye drops to help relieve dryness and irritation by lubricating and moistening the eye surface. The drops are applied directly to the eye as needed.

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: 5 mL 5 mL
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 Marketing startMarketing endStatus
82584-0700-05 82584-700-05 Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER 2024-12-01 — Active
82584-0700-11 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER 2024-12-01 — Active
82584-0700-13 82584-700-13 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER Sample 2024-12-01 — Active

Pack size FAQ

What quantity is in this package?
This package 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 iVIZIA Dry Eye povidone 25 mg/5mL 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
iVIZIA Dry Eye 25 mg/5mLthis 82584-0700-11 Thea 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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 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 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 B8WCK70T7I
    Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • 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.

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

The official label also statesPurified water, sodium chloride, sodium hyaluronate, trehalose, tromethamine. May contain hydrochloric acid 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

LabelerThea Pharma Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code82584
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio11 products on file

More NDCs from Thea Pharma Inc. labeler code 82584

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 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 71 words ▾

Uses (one or more of these) 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 and sun For use as a protectant against further irritation or to relieve dryness of the eye For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

⏱️ Dosage and Administration 53 words ▾

Directions: Wash hands well before use. Twist cap counterclockwise to break tamper evident seal. Press firmly on bottle sides. Dispensing drops is slower due to preservative-free filter. Dispense 1-2 drops in the affected eye as needed. Safe with contacts. *To limit blurriness when using contact lenses: remove contacts, apply drops, then insert contacts.

⚠️ Warnings 147 words ▾

Warnings For external use only(in the eye) Do not use if: • you are allergic to any of the ingredients. • solution changes color or becomes cloudy. • To avoid contamination, do not touch the tip of container to any surface. Replace cap after using. • If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. When using this product Rare possibility of mild eye irritation and ocular redness. In such cases, contact lens wearers should remove their contact lenses.

You might experience bothersome symptoms such as a burning sensation, stinging sensation, foreign body sensation in the eye and blurred vision for a short time.

🧪 Active Ingredient 4 words ▾

Active Ingredient Povidone 0.5%

🧪 Inactive Ingredients 17 words ▾

Inactive Ingredients Purified water, sodium chloride, sodium hyaluronate, trehalose, tromethamine. May contain hydrochloric acid to adjust pH.

🎯 Purpose 3 words ▾

Purpose Eye lubricant

📄 When Using This Product 49 words ▾

When using this product Rare possibility of mild eye irritation and ocular redness. In such cases, contact lens wearers should remove their contact lenses. You might experience bothersome symptoms such as a burning sensation, stinging sensation, foreign body sensation in the eye and blurred vision for a short time.

📄 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.

📄 Other Information 49 words ▾

Other Information • Use up to 90 days after opening. Store below 77° F. Do not use after the expiration date on the carton. Expiration date refers to the product in intact packaging, stored correctly. • After first use, if exposed to low atmospheric pressure, the bottle can drip.

📄 Questions or Comments 4 words ▾

Questions? 1-833-838-4028 or [email protected]

📄 Package Label / Principal Display Panel 16 words ▾

Principle Display Panel iVizia Sterile Lubricant Eye Drops For Dry Eyes

0.16 FL OZ (5ml) image2

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Povidone — the ingredient across all brands.

Top reported reactions

Eye Pain571
Endophthalmitis441
Drug Hypersensitivity432
Nausea386
Eye Irritation382
Pain354
Rash348

Reporter sex

7,128 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization2,090
Death708
Life-threatening505
Disabling401
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 538 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Thea Pharma 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 (82584-0700-05), 1 bottle (82584-0700-13). 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?
Thea Pharma 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.
← 82584-0609-30 · Thea 82584-0701-12 · Thea →
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.