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 9 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medics Choice Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	K.C. Pharmaceuticals, Inc.	9ddfc275-602f-413b-e053-2995a90a11cb	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Eye Drops Seasonal Relief	TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE	KC Pharmaceuticals, Inc.	92bd8cb4-90ad-4a47-afa4-30d1fa658d62	2025-12-30	Warnings	Exact identifier application number: M018
DG Health Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Dolgencorp LLC	9c62f8a3-7cf5-40f9-e053-2a95a90afd86	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Eye Drops Original Redness Reliever	TETRAHYDROZOLINE HYDROCHLORIDE	KC Pharmaceuticals, Inc.	e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Eye Drops Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	K.C. Pharmaceuticals, Inc.	f7131707-47af-d70a-e053-6394a90a418f	2025-12-30	Warnings	Exact identifier application number: M018
DG Original Eye Drops	TETRAHYDROZOLINE HCL	Dolgencorp LLC	9cb2123c-3ed4-ce8f-e053-2995a90a0ab8	2025-12-30	Warnings	Exact identifier application number: M018
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	KC Pharmaceuticals, Inc.	eb6eb6c4-1609-407b-84e4-c7509811f3c0	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Eye Drops Advanced	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE	KC Pharmaceuticals, Inc.	ab906fd8-265c-4359-a920-d626366e245c	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Fresh and Soothe Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	KC Pharmaceuticals, Inc.	1f65b91a-4eac-65c2-e063-6394a90a0295	2025-12-30	Warnings	Exact identifier application number: M018
DG Health Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400	Dolgencorp LLC	9cb20c3b-bf6d-8c7c-e053-2995a90aa485	2025-12-30	Warnings	Exact identifier application number: M018
DG Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Dolgencorp LLC	9cb27899-6c36-3c37-e053-2995a90a1d43	2025-12-30	Warnings	Exact identifier application number: M018
Publix Artificial Tears Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Publix Super Markets, Inc.	f5d1394b-0fe8-c372-e053-2a95a90a1f78	2025-12-30	Warnings	Exact identifier application number: M018
Best Choice Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Best Choice	f5ba63f3-7966-81fe-e053-2995a90a342c	2025-12-30	Warnings	Exact identifier application number: M018
DG Maximum Strength Redness Relief	GLYCERIN, NAPHAZOLINE HCL	Dolgencorp, Inc	9cb261ed-b708-1189-e053-2a95a90a547d	2025-12-30	Warnings	Exact identifier application number: M018
Publix Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Publix Super Markets, Inc.	f7b0c3d6-0324-46c3-e053-6394a90a8241	2025-12-30	Warnings	Exact identifier application number: M018
Publix Moisturizing Relief Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Publix Super Markets, Inc.	9b391400-c53b-7c7b-e053-2995a90a2731	2025-12-30	Warnings	Exact identifier application number: M018
Publix High Performance Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Publix Super Markets, Inc.	9b402aa8-87cb-3928-e053-2995a90afa3c	2025-12-30	Warnings	Exact identifier application number: M018
Kroger Eye Drops Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	The Kroger Company	f76f08c5-0111-8bc5-e053-6294a90a16ee	2025-12-30	Warnings	Exact identifier application number: M018
Health Mart Lubricating Tears	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	c8be678f-2b4a-4d39-9cb4-910d36d72174	2025-12-30	Warnings	Exact identifier application number: M018
Winco Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	WinCo Foods, LLC	ff3651d4-42ce-4db1-a318-15f7592baf86	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