FDA.reportPublic FDA data

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
IngredientStrength
POVIDONE-IODINE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
252965Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3444446-1dad-79ff-e053-2a95a90af411Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16030-601-05Aurodone Povidone Iodine 5 % Opthalmic Solution5 mL in 1 BOTTLESOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16030-601AURODONE POVIDONE IODINE 5 % OPTHALMIC SOLUTION (POVIDONE IODINE 5 % TOPICAL SOLUTION) SOLUTION [AUROLAB]2Current NDC, 1 package rows20250108_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 25 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Lubricating DropsPOLYVINYL ALCOHOLA-S Medication Solutionsf2e26f85-4081-425b-9c81-ac2a079a57432023-11-10WarningsExact identifier
application number: M018
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
application number: M018
Eyeganics Organic TearsGLYCERINEyeganics LLC42470af7-a3ae-4e14-88e0-04cd92db4b372023-10-13WarningsExact identifier
application number: M018
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
application number: M018
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
application number: M018
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
application number: M018
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
application number: M018
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
application number: M018
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
application number: M018
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
application number: M018
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier
application number: M018
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
application number: M018
CIRCLE K sterile eye dropsTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0e106c-16f6-ff4e-e063-6294a90a7dbb2018-07-30WarningsExact identifier
application number: M018
Lil Drug Store Sterile Eye Drops Redness RelieverTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0ea35c-ac52-1043-e063-6394a90a061c2018-04-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252965povidone-iodine 5 % Topical SolutionPSNf3444446-1dad-79ff-e053-2a95a90af4112
252965povidone-iodine 50 MG/ML Topical SolutionSCDf3444446-1dad-79ff-e053-2a95a90af4112
252965povidone-iodine 5 % (titratable iodine 0.5 % ) Topical SolutionSYf3444446-1dad-79ff-e053-2a95a90af4112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16030-601-05160300601055 mL in 1 BOTTLE (16030-601-05) 5 ml2023-02-01NoNoCurrent