FDA.reportPublic FDA data

iVIZIA Lubricant Eye Gel

Product NDC
82584-701
11-digit product format
825840701
Labeler code
82584
Product ID
82584-701_509e6e7c-bb53-f135-e063-6294a90a5279
Type
HUMAN OTC DRUG
Nonproprietary name
povidone
Dosage form
GEL
Route
OPHTHALMIC
Labeler
Thea Pharma Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
Substance
POVIDONE, UNSPECIFIED
Active strength
2.5 mg/.5g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
iVIZIA Lubricant Eye Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE, UNSPECIFIED2.5 mg/.5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FZ989GH94EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2623245Internal RxNorm lookup
2623248Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f06ca1a-5270-9a82-e063-6294a90aed64Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82584-701-12iVIZIA Lubricant Eye Gel30 in 1 CARTONGEL303
82584-701-12iVIZIA Lubricant Eye Gel0.4 g in 1 VIAL, SINGLE-USEGEL0.43
82584-701-60iVIZIA Lubricant Eye Gel0.4 g in 1 VIAL, SINGLE-USEGEL0.43
82584-701-60iVIZIA Lubricant Eye Gel30 in 1 CARTONGEL303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82584-701IVIZIA LUBRICANT EYE GEL (POVIDONE) GEL [THEA PHARMA INC.]1Current NDC, 4 package rows20241202_1f06ca1a-5270-9a82-e063-6294a90aed64.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EYE DROPSCARBOXYMETHYLCELLULOSE SODIUMFoshan Sugar Max Cosmetics CO.,Ltd26dbf100-593e-3778-e063-6394a90adf262025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Original FormulaTETRAHYDROZOLINE HCLGeiss, Destin & Dunn, Inc.9b44de58-6362-3811-e053-2995a90a2f372025-12-30WarningsExact identifier
application number: M018
GoodSense Redness Relief PlusGLLYCERIN, NAPHAZOLINE HYDROCHLORIDEGeiss, Destin & Dunn, Inc.9b37250f-9bdf-574e-e053-2a95a90a013e2025-12-30WarningsExact identifier
application number: M018
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Irritation ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEGeiss, Destin & Dunn, Inc.9b24fbdd-780c-1ba2-e053-2a95a90ad60f2025-12-30WarningsExact identifier
application number: M018
CVS Hydration Eye DropsPOLYETYLENE GLYCOL 400, PROPYLENE GLYCOLCVSecab8fa3-6575-0dde-e053-2a95a90abd612025-12-30WarningsExact identifier
application number: M018
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
application number: M018
Good Sense Lubricating Plus Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMGoodSenseffd6428e-3bf5-8742-e053-6394a90a4c8f2025-12-30WarningsExact identifier
application number: M018
GoodSense Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLGeiss, Destin & Dunn, Inc.9b45ebb5-c43b-c9fb-e053-2a95a90a34112025-12-30WarningsExact identifier
application number: M018
CVS Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HCICVS Pharmacy, Inc.f70f9fc4-4022-336e-e053-6394a90a4d072025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEDiscount Drug Martf5f1d3da-5300-8211-e053-2a95a90a323a2025-12-30WarningsExact identifier
application number: M018
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
application number: M018
Family Wellness Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLFamily Dollar Services, Inc.facd53c4-9cfc-6589-e053-6394a90a180d2025-12-30WarningsExact identifier
application number: M018
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
application number: M018
Family Wellness Advanced Redness Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabec215-a040-3f4e-e053-6394a90ad45f2025-12-30WarningsExact identifier
application number: M018
Family Wellness Original Redness Relief Eye DropsTETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabf540a-8d5c-bb1c-e053-6394a90a75c22025-12-30WarningsExact identifier
application number: M018
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2623248iVizia 0.5 % Ophthalmic GelPSN1f06ca1a-5270-9a82-e063-6294a90aed643
2623245povidone 0.5 % Ophthalmic GelPSN1f06ca1a-5270-9a82-e063-6294a90aed643
2623248povidone 0.005 MG/MG Ophthalmic Gel [iVizia]SBD1f06ca1a-5270-9a82-e063-6294a90aed643
2623245povidone 0.005 MG/MG Ophthalmic GelSCD1f06ca1a-5270-9a82-e063-6294a90aed643
2623248iVizia 0.005 MG/MG Ophthalmic GelSY1f06ca1a-5270-9a82-e063-6294a90aed643
2623248iVizia 0.5 % Ophthalmic GelSY1f06ca1a-5270-9a82-e063-6294a90aed643
2623245povidone 0.5 % Ophthalmic GelSY1f06ca1a-5270-9a82-e063-6294a90aed643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82584-701-128258407011230 VIAL, SINGLE-USE in 1 CARTON (82584-701-12) / .4 g in 1 VIAL, SINGLE-USE2024-12-01NoNoCurrent
82584-701-608258407016030 VIAL, SINGLE-USE in 1 CARTON (82584-701-60) / .4 g in 1 VIAL, SINGLE-USE2026-04-30YesNoCurrent