iVizia Dry Eye

Product NDC: 53799-700
11-digit product format: 537990700
Labeler code: 53799
Product ID: 53799-700_4a29d9f1-265b-4d8d-add4-15732920acc2
Type: HUMAN OTC DRUG
Nonproprietary name: Povidone
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Similasan AG
Application: part349
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-11-29
Marketing end: 0000-00-00
Substance: POVIDONE
Active strength: 25 mg/5mL
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53799-700		I	Inactivated by FDA	2026-09-09
excluded product	product	53799-700		I	Inactivated by FDA	2026-09-09
excluded product	product	53799-700		I	Inactivated by FDA	2026-09-09
excluded package	package	53799-700	53799-700-05	I	Inactivated by FDA	2026-09-09
excluded package	package	53799-700	53799-700-11	I	Inactivated by FDA	2026-09-09
excluded package	package	53799-700	53799-700-13	I	Inactivated by FDA	2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 90 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53799-700-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53799-700-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53799-700-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53799-700-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53799-700-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53799-700-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53799-700-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53799-700-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53799-700-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53799-700-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53799-700-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53799-700-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53799-700-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53799-700-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53799-700-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53799-700-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53799-700-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53799-700-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53799-700-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53799-700-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53799-700-11	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53799-700-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53799-700-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53799-700-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53799-700-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53799-700-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53799-700-11	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53799-700-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53799-700-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53799-700-11	`ad56d346431e…`	`cc804d4bbf1e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53799-700-05	2023-01-30	C162847	48780-1	f386c64a-2afc-0266-e053-dadaa90a7c1a	iVizia Dry Eye Drops 5ml
53799-700-11	2023-01-30	C162847	48780-1	f386c64a-22a5-0266-e053-dadaa90a7c1a	iVizia Dry Eye Drops 10ml
53799-700-13	2023-01-30	C162847	48780-1	f386c64a-19bd-0266-e053-dadaa90a7c1a	iVizia Dry Eye Drops 5ml Sample

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53799-700-13	iVizia Dry Eye	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	2
53799-700-05	iVizia Dry Eye	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	1
53799-700-11	iVizia Dry Eye	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53799-700	IVIZIA DRY EYE (POVIDONE) SOLUTION/ DROPS [SIMILASAN AG]	2	Legacy NDC, 1 package rows	20211001_25787325-c4e9-4cb1-bbc8-6cd3da18af0f.zip
53799-700	IVIZIA DRY EYE (POVIDONE) SOLUTION/ DROPS [SIMILASAN AG]	1	Legacy NDC, 1 package rows	20211129_fc523fc4-9703-4427-85c3-d07075dc8d43.zip
53799-700	IVIZIA DRY EYE (POVIDONE) SOLUTION/ DROPS [SIMILASAN AG]	1	Legacy NDC, 1 package rows	20211129_9f2171f6-d691-4fb9-a1b1-f8cffbeff6cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2586186	iVIZIA 0.5 % Ophthalmic Solution	PSN	25787325-c4e9-4cb1-bbc8-6cd3da18af0f	2
2570860	povidone 0.5 % Ophthalmic Solution	PSN	25787325-c4e9-4cb1-bbc8-6cd3da18af0f	2
2586186	povidone 5 MG/ML Ophthalmic Solution [iVizia]	SBD	25787325-c4e9-4cb1-bbc8-6cd3da18af0f	2
2570860	povidone 5 MG/ML Ophthalmic Solution	SCD	25787325-c4e9-4cb1-bbc8-6cd3da18af0f	2
2586186	iVizia 0.5 % Ophthalmic Solution	SY	25787325-c4e9-4cb1-bbc8-6cd3da18af0f	2
2586186	iVizia 5 MG/ML Ophthalmic Solution	SY	25787325-c4e9-4cb1-bbc8-6cd3da18af0f	2
2570860	povidone 0.5 % Ophthalmic Solution	SY	25787325-c4e9-4cb1-bbc8-6cd3da18af0f	2
2586186	iVIZIA 0.5 % Ophthalmic Solution	PSN	fc523fc4-9703-4427-85c3-d07075dc8d43	1
2586186	iVIZIA 0.5 % Ophthalmic Solution	PSN	9f2171f6-d691-4fb9-a1b1-f8cffbeff6cc	1
2570860	povidone 0.5 % Ophthalmic Solution	PSN	9f2171f6-d691-4fb9-a1b1-f8cffbeff6cc	1
2570860	povidone 0.5 % Ophthalmic Solution	PSN	fc523fc4-9703-4427-85c3-d07075dc8d43	1
2586186	povidone 5 MG/ML Ophthalmic Solution [iVizia]	SBD	9f2171f6-d691-4fb9-a1b1-f8cffbeff6cc	1
2586186	povidone 5 MG/ML Ophthalmic Solution [iVizia]	SBD	fc523fc4-9703-4427-85c3-d07075dc8d43	1
2570860	povidone 5 MG/ML Ophthalmic Solution	SCD	fc523fc4-9703-4427-85c3-d07075dc8d43	1
2570860	povidone 5 MG/ML Ophthalmic Solution	SCD	9f2171f6-d691-4fb9-a1b1-f8cffbeff6cc	1
2586186	iVizia 0.5 % Ophthalmic Solution	SY	9f2171f6-d691-4fb9-a1b1-f8cffbeff6cc	1
2586186	iVizia 0.5 % Ophthalmic Solution	SY	fc523fc4-9703-4427-85c3-d07075dc8d43	1
2586186	iVizia 5 MG/ML Ophthalmic Solution	SY	9f2171f6-d691-4fb9-a1b1-f8cffbeff6cc	1
2586186	iVizia 5 MG/ML Ophthalmic Solution	SY	fc523fc4-9703-4427-85c3-d07075dc8d43	1
2570860	povidone 0.5 % Ophthalmic Solution	SY	9f2171f6-d691-4fb9-a1b1-f8cffbeff6cc	1
2570860	povidone 0.5 % Ophthalmic Solution	SY	fc523fc4-9703-4427-85c3-d07075dc8d43	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53799-700-05	53799070005	5 mL in 1 BOTTLE, DROPPER (53799-700-05)	5 ml	2021-11-29	0000-00-00	Yes	No	Current
53799-700-11	53799070011	10 mL in 1 BOTTLE, DROPPER (53799-700-11)	10 ml	2021-11-29	0000-00-00	No	No	Current
53799-700-13	53799070013	5 mL in 1 BOTTLE, DROPPER (53799-700-13)	5 ml	2021-09-30	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
iVizia Dry Eye Drops 5ml	Similasan AG	2021-11-29	HUMAN OTC DRUG LABEL	1
iVizia Dry Eye Drops 10ml	Similasan AG	2021-11-29	HUMAN OTC DRUG LABEL	1
iVizia Dry Eye Drops 5ml Sample	Similasan AG	2021-09-17	HUMAN OTC DRUG LABEL	2