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iVIZIA Lubricant Eye Gel povidone 2.5 mg/.5g Gel, 30 vials

by Thea Pharma Inc. · 30 VIAL, SINGLE-USE in 1 CARTON (82584-701-12) / .4 g in 1 VIAL, SINGLE-USE
NDC 82584-0701-12
🏷️ FDA NDC (as labeled) 82584-701-12 billing pads the product segment with a zero
This package
Contains30 vials Pack sizes2 compare ↓
Also comes in: 30 vials 82584-0701-60
OTC On market Non-controlled
🗂️ Data synced 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 Povidone (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, 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
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 82584-701-12
Product NDC 82584-701
11-digit billing NDC 82584070112
NCPDP billing unit EA — each (per item)
RxCUI 2623245, 2623248
UNII FZ989GH94E
UPC 0382584701123
Application # M018
SPL Set ID 1f06ca1a-5270-9a82-e063-6294a90aed64
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 GEL
Substance POVIDONE, UNSPECIFIED
GCN Seq No 084070
GCN 53207
HICL code 038315
Ingredient (HICL) Povidone/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 IVIZIA 0.5% EYE GEL
FDB brand name Ivizia
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 82584-701-12 — 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 → 82584-0701-12. 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

LabelerThea Pharma Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code82584
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio11 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 IVIZIA 0.5% EYE GEL Ingredient Povidone/Pf
🧪 What is this product?

iVIZIA Lubricant Eye Gel is an over-the-counter eye lubricant product available as a gel for application directly to the eye. The active ingredient is povidone, a substance commonly used in eye care products to help lubricate and protect the surface of the eye. This type of product is typically used to relieve dryness and discomfort in the eye.

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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • 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 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 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 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 statesCarbomer, Purified water, Sodium hyaluronate, Sodium hydroxide, Sorbitol, Trehalose

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 gPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
iVIZIA Lubricant Eye Gel 2.5 mg/.5gthis 82584-0701-12 Thea 30 vials — — 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.

🔬 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 iVIZIA Lubricant Eye Gel (this brand).

Top reported reactions

Nausea22
Visual Acuity Reduced15
Headache14
Drug Hypersensitivity13
Drug Interaction13
Acute Kidney Injury12
Drug Intolerance12

Reporter sex

0 reports

Serious outcomes

Death25
Life-threatening10
Disabling8
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 19 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
82584-0701-12 You're viewing this 30 VIAL, SINGLE-USE in 1 CARTON (82584-701-12) / .4 g in 1 VIAL, SINGLE-USE 2024-12-01 Active
82584-0701-60 30 VIAL, SINGLE-USE in 1 CARTON (82584-701-60) / .4 g in 1 VIAL, SINGLE-USE 2026-04-30 Active

Pack size FAQ

What quantity is in NDC 82584-0701-12?
NDC 82584-0701-12 contains 30 vials — 30 vial, single-use in 1 carton / .4 g in 1 vial, single-use.
What is the difference between NDC 82584-0701-12 and NDC 82584-0701-60?
Both are iVIZIA Lubricant Eye Gel povidone 2.5 mg/.5g Gel — the drug itself is identical. NDC 82584-0701-12 is the 30 vials package, while NDC 82584-0701-60 is the 30 vials package.
What NDC number is used to bill for this package of iVIZIA Lubricant Eye Gel povidone 2.5 mg/.5g Gel?
Bill NDC 82584-0701-12 — the 11-digit billing format is 82584070112. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC No photo available yet for this listing.
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 FDA registers it as 82584-701-12, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 82584-0701-12, written without dashes as 82584070112. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 82584-0701-12, the first segment (82584) is the labeler code FDA assigned to Thea Pharma Inc.; the middle segment (0701) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) identifies this exact package size and type. Together they name one specific package of one specific product.
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 1 other package presentation of this same product, including 30 vials (82584-0701-60). 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.

📄 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
🎯 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 91 words ▾

Directions • Wash hands well before use. • Take one single-use vial off the strip. Turn upside down, tap the vial and twist off the top. • Instill 1 or 2 drops in the affected eye(s) as needed. Gel is particularly suited for severe dry eye or nighttime use. • Wait at least 15 minutes between using two different eye products.

Use this gel last. If you wear contact lenses: you must remove them before using iVIZIA gel. After use wait at least 30 minutes before putting your lenses back in.

⚠️ Warnings 174 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. • pouch or vial is damaged or broken • To avoid contamination, do not touch the tip of container to any surface. Do not reuse. Once opened, discard. • 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.

If pregnant, trying to get pregnant or breast feeding, ask a health professional before use. 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 wears should remove their contact lenses. • You might experience bothersome symptoms such as 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 11 words ▾

Inactive ingredients Carbomer, Purified water, Sodium hyaluronate, Sodium hydroxide, Sorbitol, Trehalose

🎯 Purpose 3 words ▾

Purpose Eye lubricant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82584-0700-05 · Thea 82584-0792-01 · 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.