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 23 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Better Living Brands LLC	5d7228ce-f108-4cc2-9aec-8b4548c3a155	2023-12-20	Warnings	Exact identifier application number: M018
Target Eye Drops Maximum Redness Relief Eye	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Target Corporation	1b26cd3b-4a05-4623-b320-01f22b3106ff	2023-12-20	Warnings	Exact identifier application number: M018
Kroger High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Kroger	d2aa8963-1922-02f3-e053-2a95a90a7d93	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Eye Drops Seasonal Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Kroger	f6829be4-e3b7-7ff2-e053-2995a90a80fc	2023-12-20	Warnings	Exact identifier application number: M018
Rite Aid Multi-Symptom Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Rite Aid Corporation	efa7d208-9d42-13c7-e053-2a95a90a11b3	2023-12-20	Warnings	Exact identifier application number: M018
Signature Care Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Better Living Brands LLC	ea358e01-f03e-454b-bae1-6c83da44c369	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Original Eye Drops	TETRAHYDROZOLINE HCL	Topco Associates LLC	9c61a56a-c1a9-2846-e053-2995a90a755b	2023-12-20	Warnings	Exact identifier application number: M018
Signature Care Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	Better Living Brands LLC	f685aca4-93d0-26d9-e053-2995a90a6e51	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Lubricant Eye	CARBOXYMETHYLCELLULOSE SODIUM	The Kroger Co.	046f4ebc-d8f9-4755-b6ba-790fe86f3128	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Kroger Company	f7ad77fc-d890-25b9-e053-6394a90a2b12	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Topco Associates LLC	9c617e34-fc66-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier application number: M018
Equaline Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	United Natural Foods, Inc.	f7602789-179a-edfc-e053-6294a90a0844	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Ultra Itch Relief Astringent Eye Drops	TETRAHYDROZOLINE HCL, ZINC SULFATE	Topco Associates LLC	9c617e34-fc64-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Topco Associates LLC	9c614c0e-5862-682f-e053-2a95a90abc09	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Topco Assoc LLC	9c6284f9-00bb-37b5-e053-2a95a90ae2ee	2023-12-20	Warnings	Exact identifier application number: M018
HEB Dry Eye Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	HEB	f80023cf-8e42-780a-e053-6294a90a66cd	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Advanced Moisturizing Plus Redness Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Topco Associates LLC	9c6193a6-d822-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Topco Assoc LLC	9c6193a6-d824-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
HEB Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	HEB	5d522e4d-d647-486f-a947-25c14b1417fa	2023-12-20	Warnings	Exact identifier application number: M018
HEB A.C. Eye Drops	TETRAHYDROZOLINE HCL, ZINC SULFATE	HEB Grocery Company., LP	f680a8c1-dc91-7a52-e053-2a95a90a571e	2023-12-20	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