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 17 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eyesaline Eyewash Concentrate	PURIFIED WATER	Honeywell Safety Products, Inc.	2d90c8e8-f479-3535-e063-6394a90af122	2025-02-07	Warnings	Exact identifier application number: M018
Code Red Eye Drops Redness Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	4 Trees, LLC	0aa08018-cc2d-d947-e063-6394a90a914a	2025-02-07	Warnings	Exact identifier application number: M018
Tyson 2.0 Mike Red Eye Drops For Dry High Eyes	GLYCERIN, NAPHAZOLINE HCL	Jbrands Pharma L.L.C.	288e9c85-0562-89bf-e063-6394a90a110d	2025-02-07	Warnings	Exact identifier application number: M018
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Citragen Pharmaceuticals Inc	aae783b2-18fe-69ca-e053-2a95a90a0800	2025-01-30	Warnings	Exact identifier application number: M018
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Citragen Pharmaceuticals Inc	82c29f1d-a018-7483-e053-2a91aa0a8f7e	2025-01-30	Warnings	Exact identifier application number: M018
OASIS Tears Lubricant Eye	GLYCERIN	OASIS Medical, Inc.	00071697-4ac6-4962-8eee-388b8b52bd40	2025-01-22	Warnings	Exact identifier application number: M018
ImproVue Lubricant	HYPROMELLOSE 2208 (15000 MPA.S)	Oculus Surgical, Inc.	63b82129-4848-47c5-bf92-ec4b1a9e9974	2025-01-22	Warnings	Exact identifier application number: M018
VISCO SHIELD Lubricant	HYPROMELLOSE 2208 (15000 MPA.S)	OASIS Medical, Inc.	72d22610-d8ab-4f24-b304-8b013430a7d7	2025-01-22	Warnings	Exact identifier application number: M018
OASIS Tears Plus Preservative-Free Lubricant Eye	GLYCERIN	OASIS Medical, Inc.	ea931c0f-c61e-4771-84f1-0274b1c3e28e	2025-01-22	Warnings	Exact identifier application number: M018
Medics Choice Soothing Eye Wash	PURIFIED WATER	KC Pharmaceuticals, Inc.	10e49808-161e-f4ec-e063-6294a90a1775	2025-01-19	Warnings	Exact identifier application number: M018
Sodium Chloride Hypertonicity Ophthalmic Solution, 5%	SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%	Reliable 1 Laboritories LLC	29175c17-223e-5e92-e063-6294a90a71d2	2025-01-15	Warnings	Exact identifier application number: M018
Lubricating Tears	CARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTION	Reliable 1 Laboritories LLC	29023a57-eba3-4241-e063-6294a90a7048	2025-01-15	Warnings	Exact identifier application number: M018
Aurodone Povidone Iodine 5 % Opthalmic Solution	POVIDONE IODINE 5 % TOPICAL SOLUTION	Aurolab	f3444446-1dad-79ff-e053-2a95a90af411	2025-01-06	Warnings	Exact identifier application number: M018 ndc (product): 16030-601
Hypromellose Eye Drops 0.7%	HYPROMELLOSE EYE DROPS 0.7%	Aurolab	d35313d0-b190-5fb0-e053-2a95a90a5283	2025-01-02	Warnings	Exact identifier application number: M018
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 ml	PROPYLENE GLYCOL	Red Wedding LLC	b2c2fd0f-b944-6b0b-e053-2995a90aa216	2025-01-01	Warnings	Exact identifier application number: M018
Rite Aid Hydration Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Rite Aid Corporation	ecac1351-e944-21da-e053-2995a90a6d34	2024-12-31	Warnings	Exact identifier application number: M018
Lubricant Eye PM	MINERAL OIL, WHITE PETROLATUM	Reliable 1 Laboratories LLC	baec8045-97fe-6f60-e053-2a95a90a050e	2024-12-31	Warnings	Exact identifier application number: M018
Lil Drug Store Eye Drops Redness Reliever	TETRAHYDROZOLINE HYDROCHLORIDE	Lil Drug Store Products, Inc	d2a47e98-a04c-47ec-aded-d1c894f040e2	2024-12-30	Warnings	Exact identifier application number: M018
Rain Renewal Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Rain Eye Drops, LLC	af7a5768-7d1d-3d93-e053-2a95a90a38f6	2024-12-29	Warnings	Exact identifier application number: M018
Glitch Advanced Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	Misemer Pharmaceutical, Inc	03778509-3374-2168-e063-6294a90a9505	2024-12-23	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