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 14 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb479d2ae-4b59-916a-e053-2995a90af8ec2025-11-11WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDERising Pharma Holdings, Inc.42870188-b1d7-4934-a6c0-310530497dac2025-11-07WarningsExact identifier
application number: M018
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
application number: M018
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
application number: M018
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
application number: M018
Up and Up Dry Eye Relief Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMTarget Corporation3b1834e6-75cf-5380-e063-6294a90ad1d52025-10-25WarningsExact identifier
application number: M018
Up and Up Dry Eye Relief Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHanlim420274c6-7bf0-0920-e063-6294a90a30be2025-10-25WarningsExact identifier
application number: M018
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
application number: M018
TheraTears LubricantCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC797b0394-2f0f-4733-8d20-ec5bdf3e085d2025-10-23WarningsExact identifier
application number: M018
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
application number: M018
TheraTears LubricantCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC661d8764-8ae6-4229-9485-867553ee8e162025-10-23WarningsExact identifier
application number: M018
Refresh Relieva Preservative FreeCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.3481f9b3-5a90-40d3-80f8-81f51cc864be2025-10-22WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
application number: M018
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
application number: M018
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
application number: M018
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
application number: M018
Xpect Industrial Eye ReliefGLYCERIN, NAPHAZOLINE HCLCintas Corporationa0167d06-7adb-36f4-e053-2a95a90af9ef2025-09-30WarningsExact identifier
application number: M018
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
application number: M018
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
application number: M018
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact 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