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
Ingredient	Strength
POVIDONE, UNSPECIFIED	2.5 mg/.5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FZ989GH94E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1f06ca1a-5270-9a82-e063-6294a90aed64	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82584-701-12	iVIZIA Lubricant Eye Gel	30 in 1 CARTON	GEL	30	3
82584-701-12	iVIZIA Lubricant Eye Gel	0.4 g in 1 VIAL, SINGLE-USE	GEL	0.4	3
82584-701-60	iVIZIA Lubricant Eye Gel	0.4 g in 1 VIAL, SINGLE-USE	GEL	0.4	3
82584-701-60	iVIZIA Lubricant Eye Gel	30 in 1 CARTON	GEL	30	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82584-701	IVIZIA LUBRICANT EYE GEL (POVIDONE) GEL [THEA PHARMA INC.]	1	Current NDC, 4 package rows	20241202_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 19 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eye Wash	WATER	Hubei Changjian Medical Products Co., Ltd.	d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea	2024-10-11	Warnings	Exact identifier application number: M018
Capasil Pain Relieving	MENTHOL, METHYL SALICYLATE	PureTek Corporation	b1a8e78c-57f0-1f3e-e053-2995a90acbd5	2024-10-01	Warnings	Exact identifier application number: M018
Mencylate Pain Relieving	MENTHOL, METHYL SALICYLATE	PureTek Corporation	f824de86-9492-2e6b-e053-6294a90a6f2a	2024-10-01	Warnings	Exact identifier application number: M018
Advanced Eye Relief/ Redness Maximum Relief	NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE	Bausch & Lomb Incorporated	3c11285a-7e86-4b47-b1ee-e7d59858087d	2024-09-25	Warnings	Exact identifier application number: M018
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	cc3d5bc8-9d3c-4c65-9e43-707a2db4081a	2024-09-25	Warnings	Exact identifier application number: M018
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	93fafa27-5031-4d95-b4b8-5574b7204ae2	2024-09-25	Warnings	Exact identifier application number: M018
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	454f337e-d897-46de-ab05-1c543a33061c	2024-09-25	Warnings	Exact identifier application number: M018
PURPOSE	OCTINOXATE, OCTISALATE AND OXYBENZONE	Bausch & Lomb Incorporated	a1e14135-b8da-4cee-8c5b-1893572f4de4	2024-09-25	Warnings	Exact identifier application number: M018
Soothe Night Time	WHITE PETROLATUM MINERAL OIL	Bausch & Lomb Incorporated	638d3c3f-9960-43da-956e-0e28c77f533e	2024-09-24	Warnings	Exact identifier application number: M018
blink tears	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	10fcf407-6eaf-4730-9ed0-9b7715cf5701	2024-09-20	Warnings	Exact identifier application number: M018
Soothe XP Preservative Free	LIGHT MINERAL OIL AND MINERAL OIL	Bausch & Lomb Incorporated	b254d885-6d49-4c95-b6be-cfdad49c85e6	2024-09-20	Warnings	Exact identifier application number: M018
blink gel tears	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	6f7e06c3-204d-459a-af8f-c46be9ad0e8d	2024-09-20	Warnings	Exact identifier application number: M018
Soothe XP	LIGHT MINERAL OIL AND MINERAL OIL	Bausch & Lomb Incorporated	c0f053da-8d22-433e-a36e-79cf15ad387f	2024-09-20	Warnings	Exact identifier application number: M018
Soothe	GLYCERIN AND PROPYLENE GLYCOL	Bausch & Lomb Incorporated	fef002ea-c4bd-4486-a42e-1bbd9d73d28d	2024-09-20	Warnings	Exact identifier application number: M018
Leader Preservative-Free Ultra Lubricating Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Cardinal Health	2a2aa620-ca63-4698-88fd-fc263b8fa0d1	2024-09-07	Warnings	Exact identifier application number: M018
Eyesaline Emergency Eyewash	PURIFIED WATER	Honeywell Safety Products USA, Inc.	ad42a7e3-84ea-390d-e053-2a95a90a3a32	2024-06-14	Warnings	Exact identifier application number: M018
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	NuCare Pharmaceuticals,Inc.	9c1c4911-908e-3c3c-e053-2995a90abcfc	2024-06-14	Warnings	Exact identifier application number: M018
Eyes Alive Eye Wash	WATER	RIVIERA PHARMA INC	081079f4-1c06-4054-b771-00fedaa666f6	2024-06-05	Warnings	Exact identifier application number: M018
Eyes Alive Lubricating	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	RIVIERA PHARMA INC	b6966691-6884-438c-9f89-5924089226e1	2024-05-31	Warnings	Exact identifier application number: M018
Eye Wash	WATER	M-star (Hubei) Health&Care Products Co., Ltd.	71706039-e250-4f08-9687-71b2928c4e46	2024-04-01	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FZ989GH94E	POVIDONE, UNSPECIFIED	9003-39-8	POVIDONE, UNSPECIFIED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2623248	iVizia 0.5 % Ophthalmic Gel	PSN	1f06ca1a-5270-9a82-e063-6294a90aed64	3
2623245	povidone 0.5 % Ophthalmic Gel	PSN	1f06ca1a-5270-9a82-e063-6294a90aed64	3
2623248	povidone 0.005 MG/MG Ophthalmic Gel [iVizia]	SBD	1f06ca1a-5270-9a82-e063-6294a90aed64	3
2623245	povidone 0.005 MG/MG Ophthalmic Gel	SCD	1f06ca1a-5270-9a82-e063-6294a90aed64	3
2623248	iVizia 0.005 MG/MG Ophthalmic Gel	SY	1f06ca1a-5270-9a82-e063-6294a90aed64	3
2623248	iVizia 0.5 % Ophthalmic Gel	SY	1f06ca1a-5270-9a82-e063-6294a90aed64	3
2623245	povidone 0.5 % Ophthalmic Gel	SY	1f06ca1a-5270-9a82-e063-6294a90aed64	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82584-701-12	82584070112	30 VIAL, SINGLE-USE in 1 CARTON (82584-701-12) / .4 g in 1 VIAL, SINGLE-USE	2024-12-01	No	No	Current
82584-701-60	82584070160	30 VIAL, SINGLE-USE in 1 CARTON (82584-701-60) / .4 g in 1 VIAL, SINGLE-USE	2026-04-30	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
iVIZIA Lubricant Eye Gel for Nighttime Dry Eyes	Thea Pharma Inc.	2026-04-29	HUMAN OTC DRUG LABEL	3