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 15 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refresh RelievaCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.6b984fa2-4187-45ef-b7d3-15e720abc6672025-09-15WarningsExact identifier
application number: M018
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
application number: M018
Oasis Tears PF Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.640f95f4-c2e8-48ad-ad40-f76bbaddb0dc2025-09-12WarningsExact identifier
application number: M018
Lubricant DropsCARBOXYMETHYLCELLULOSE SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER1ac2fe24-9ff6-48c1-b123-fbc0e48f53042025-09-12WarningsExact identifier
application number: M018
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
application number: M018
Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUMCARDINAL HEALTH 110, LLC. DBA LEADERbd262028-32e9-052d-e053-2a95a90a53032025-09-12WarningsExact identifier
application number: M018
Oasis TEARS PF PLUS Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.5d080191-423d-4c0a-b5ae-2ccf5c4a67cb2025-09-08WarningsExact identifier
application number: M018
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
application number: M018
Splash RefreshHYPROMELLOSELABORATORIOS SOPHIA, S.A. DE C.V.3c1c453e-2644-622a-e063-6394a90a8a942025-09-02WarningsExact identifier
application number: M018
Refresh RELIEVA PFCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.d5d3df4a-a311-4f2d-9a24-edfec1a6c9f92025-08-22WarningsExact identifier
application number: M018
Refresh OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
application number: M018
StyeMINERAL OIL AND PETROLATUMInsight Pharmaceuticals LLCf7eb8466-d8ea-4833-9bed-244ead38a3bf2025-08-11WarningsExact identifier
application number: M018
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
application number: M018
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
application number: M018
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
application number: M018
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINKC Pharmaceuticals, Inc.3bc03d54-6b31-5921-e063-6294a90af5992025-08-01WarningsExact identifier
application number: M018
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMHanlim Pharm Co. , LTD3b329232-a562-6893-e063-6394a90aa41f2025-07-31WarningsExact identifier
application number: M018
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
application number: M018
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
application number: M018
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact 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