FDA.reportPublic FDA data

Povidone Iodine Prep

Product NDC
68786-132
11-digit product format
687860132
Labeler code
68786
Product ID
68786-132_3e014f0c-43e0-482e-e063-6294a90a44ce
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sion Biotext Medical Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-16
Substance
POVIDONE-IODINE
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68786-132-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68786-132-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68786-132-019bebd1f3094a…5416666fcb17…

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
Povidone Iodine Prep
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE1 g/100mL

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
312564Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e05af551-647d-4278-bb7f-86f888ddbb8bAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68786-132-012022-01-03C16284748780-19d75b9d0-45f7-f424-e053-dadaa90a57ceDrug Facts
68786-132-012020-01-31C16284748780-19d75b9d0-45f7-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-132-01Povidone Iodine Prep22.18 mL in 1 PACKETSOLUTION22.185
68786-132-01Povidone Iodine Prep500 in 1 CASESOLUTION5005
68786-132-02Povidone Iodine Prep100 in 1 CASESOLUTION1005
68786-132-02Povidone Iodine Prep22.18 mL in 1 PACKETSOLUTION22.185

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPOVIDONE IODINE PREP (POVIDONE IODINE) SOLUTION [SION BIOTEXT MEDICAL LTD]1
IODINEACTIVE MOIETY9679TC07X4POVIDONE IODINE PREP (POVIDONE IODINE) SOLUTION [SION BIOTEXT MEDICAL LTD]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TPOVIDONE IODINE PREP (POVIDONE IODINE) SOLUTION [SION BIOTEXT MEDICAL LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RPOVIDONE IODINE PREP (POVIDONE IODINE) SOLUTION [SION BIOTEXT MEDICAL LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-132POVIDONE IODINE PREP (POVIDONE IODINE) SOLUTION [SION BIOTEXT MEDICAL LTD]4Current NDC, Legacy NDC, 4 package rows20240125_e05af551-647d-4278-bb7f-86f888ddbb8b.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 68 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Green Guard Antiseptic WipesBENZALKONIUM CHLORIDEUniforst First Aid Corporation5744f9a2-35c6-37df-e053-2991aa0a1ca92025-09-08WarningsExact identifier
application number: M003
Green Guard Antiseptic WipesBENZALKONIUM CHLORIDEUnifirst First Aid Corporationd2ccdd9a-469e-18eb-e053-2995a90a11962025-09-08WarningsExact identifier
application number: M003
Medi-First Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce650cb6-5398-29e7-e053-2995a90ac7972025-09-08WarningsExact identifier
application number: M003
MediFirst Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporation8d17a840-b655-4e03-bc16-8ba033c3368d2025-09-08WarningsExact identifier
application number: M003
Medi-First Sting ReliefBENZOCAINE 6%, ISOPROPYL ALCOHOL 60%Unifirst First Aid Corporation6e610821-b030-930b-e053-2a91aa0a66f92025-09-08WarningsExact identifier
application number: M003
Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation81363387-d4b1-4c3f-b67f-5017361c0fcd2025-09-08WarningsExact identifier
application number: M003
Medi-First Isopropyl AlcoholISOPROPYL ALCOHOLUnifirst First Aid Corporationdbee035e-094f-f8a3-e053-2995a90a66202025-09-08WarningsExact identifier
application number: M003
Medi-First Isopropyl Alcohol 70%ISOPROPYL ALCOHOLUnifirst First Aid Corporationdbfbf8cf-201b-2277-e053-2995a90a6e452025-09-08WarningsExact identifier
application number: M003
Medi-First PVP Iodine WipesPOVIDONE IODINE 10%Unifirst-First Aid406b4a37-816a-5ea4-e054-00144ff88e882025-09-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporation7560c80b-8952-4748-af3a-20e3d42556952025-09-08WarningsExact identifier
application number: M003
Green Guard Derma-Caine BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCLUnifirst First Aid Corporation67629392-7e02-321a-e053-2991aa0a0f242025-09-08WarningsExact identifier
application number: M003
Medi-First Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb3ef1ef5-1f6f-874a-e053-2995a90a32b12025-09-08WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationa0f58025-2c50-45dc-94db-cacbd4cf604c2025-09-08WarningsExact identifier
application number: M003
Green Guard Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce6992d8-037f-61c7-e053-2a95a90ad0b02025-09-08WarningsExact identifier
application number: M003
Green Guard Antimicrobial TowelettesETHYL ALCOHOL 66.5%Unifirst First Aid Corporation6e5ddc39-f1f1-f2dd-e053-2991aa0aa9c52025-09-08WarningsExact identifier
application number: M003
Green Guard AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationb4627f3f-6282-51bf-e053-2a95a90a3d592025-09-08WarningsExact identifier
application number: M003
Green Guard Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationb463d09c-4b33-3774-e053-2a95a90a046b2025-09-08WarningsExact identifier
application number: M003
Thompson Burn Cream with LidocainBENZALKONIUM CHLORIDE, LIDOCAINEThompson Safety11729e6b-b911-5c1f-e063-6394a90a0c342025-09-08WarningsExact identifier
application number: M003
Thompson Hand SanitizerALCOHOL GELThompson06beaf35-f814-bf9b-e063-6294a90aec8c2025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e41580a-64c5-480f-e063-6294a90a4bf12025-09-07WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSNe05af551-647d-4278-bb7f-86f888ddbb8b5
312564povidone-iodine 100 MG/ML Topical SolutionSCDe05af551-647d-4278-bb7f-86f888ddbb8b5
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYe05af551-647d-4278-bb7f-86f888ddbb8b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68786-132-0168786013201500 PACKET in 1 CASE (68786-132-01) / 22.18 mL in 1 PACKET500 packet2015-07-160000-00-00NoNoCurrent
68786-132-0268786013202100 PACKET in 1 CASE (68786-132-02) / 22.18 mL in 1 PACKET100 packet2015-07-16NoNoCurrent