Aurodone Povidone Iodine 5 % Opthalmic Solution

Product NDC: 16030-601
11-digit product format: 160300601
Labeler code: 16030
Product ID: 16030-601_2b059a40-6782-b690-e063-6394a90a06a1
Type: HUMAN OTC DRUG
Nonproprietary name: Povidone Iodine 5 % Topical Solution
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Aurolab
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-01-31
Substance: POVIDONE-IODINE
Active strength: 5 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Aurodone Povidone Iodine 5 % Opthalmic Solution
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE-IODINE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
85H0HZU99M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
252965	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
f3444446-1dad-79ff-e053-2a95a90af411	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16030-601-05	Aurodone Povidone Iodine 5 % Opthalmic Solution	5 mL in 1 BOTTLE	SOLUTION	5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16030-601	AURODONE POVIDONE IODINE 5 % OPTHALMIC SOLUTION (POVIDONE IODINE 5 % TOPICAL SOLUTION) SOLUTION [AUROLAB]	2	Current NDC, 1 package rows	20250108_f3444446-1dad-79ff-e053-2a95a90af411.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EYE DROPS	CARBOXYMETHYLCELLULOSE SODIUM	Foshan Sugar Max Cosmetics CO.,Ltd	26dbf100-593e-3778-e063-6394a90adf26	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Original Formula	TETRAHYDROZOLINE HCL	Geiss, Destin & Dunn, Inc.	9b44de58-6362-3811-e053-2995a90a2f37	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Redness Relief Plus	GLLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Geiss, Destin & Dunn, Inc.	9b37250f-9bdf-574e-e053-2a95a90a013e	2025-12-30	Warnings	Exact identifier application number: M018
CVS Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	CVS Pharmacy, Inc.	f74a2fca-902c-f68a-e053-6394a90abb88	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Irritation Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Geiss, Destin & Dunn, Inc.	9b24fbdd-780c-1ba2-e053-2a95a90ad60f	2025-12-30	Warnings	Exact identifier application number: M018
CVS Hydration Eye Drops	POLYETYLENE GLYCOL 400, PROPYLENE GLYCOL	CVS	ecab8fa3-6575-0dde-e053-2a95a90abd61	2025-12-30	Warnings	Exact identifier application number: M018
Good Sense Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Geiss, Destin & Dunn, Inc.	9b243301-2e4b-5706-e053-2995a90a9b90	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Geiss, Derstin & Dunn, Inc.	9b34de99-13df-201a-e053-2a95a90ae559	2025-12-30	Warnings	Exact identifier application number: M018
Good Sense Lubricating Plus Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	GoodSense	ffd6428e-3bf5-8742-e053-6394a90a4c8f	2025-12-30	Warnings	Exact identifier application number: M018
GoodSense Ultra Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Geiss, Destin & Dunn, Inc.	9b45ebb5-c43b-c9fb-e053-2a95a90a3411	2025-12-30	Warnings	Exact identifier application number: M018
CVS Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HCI	CVS Pharmacy, Inc.	f70f9fc4-4022-336e-e053-6394a90a4d07	2025-12-30	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Discount Drug Mart, Inc.	f75c2f84-a28c-5807-e053-6294a90a2295	2025-12-30	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Discount Drug Mart	f7fd53be-e501-d97f-e053-6394a90ad409	2025-12-30	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	Discount Drug Mart	f5f1d3da-5300-8211-e053-2a95a90a323a	2025-12-30	Warnings	Exact identifier application number: M018
Exchange Select Eye Drops Advanced Relief Moisturizer	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Army and Air Force Exchange Service	9e475240-2df1-9bee-e053-2995a90a8d4b	2025-12-30	Warnings	Exact identifier application number: M018
Family Wellness Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Family Dollar Services, Inc.	facd53c4-9cfc-6589-e053-6394a90a180d	2025-12-30	Warnings	Exact identifier application number: M018
Exchange Select Artificial Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Army and Air Force Exchange Service	9e478343-8ae7-823e-e053-2995a90a84ed	2025-12-30	Warnings	Exact identifier application number: M018
Family Wellness Advanced Redness Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	Family Dollar Services, Inc.	fabec215-a040-3f4e-e053-6394a90ad45f	2025-12-30	Warnings	Exact identifier application number: M018
Family Wellness Original Redness Relief Eye Drops	TETRAHYDROZOLINE HCL	Family Dollar Services, Inc.	fabf540a-8d5c-bb1c-e053-6394a90a75c2	2025-12-30	Warnings	Exact identifier application number: M018
Family Wellness Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Family Dollar Services, Inc.	facd329b-1923-61df-e053-6294a90ab738	2025-12-30	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
85H0HZU99M	POVIDONE-IODINE	25655-41-8	POVIDONE-IODINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
252965	povidone-iodine 5 % Topical Solution	PSN	f3444446-1dad-79ff-e053-2a95a90af411	2
252965	povidone-iodine 50 MG/ML Topical Solution	SCD	f3444446-1dad-79ff-e053-2a95a90af411	2
252965	povidone-iodine 5 % (titratable iodine 0.5 % ) Topical Solution	SY	f3444446-1dad-79ff-e053-2a95a90af411	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
16030-601-05	16030060105	5 mL in 1 BOTTLE (16030-601-05)	5 ml	2023-02-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aurodone Povidone Iodine 5 % Opthalmic Solution - Aurolab	Aurolab	2025-01-06	HUMAN OTC DRUG LABEL	2