FDA.reportPublic FDA data

Povidone Iodine

Product NDC
68786-130
11-digit product format
687860130
Labeler code
68786
Product ID
68786-130_48334c7e-371d-00ff-e063-6394a90a3f42
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SWAB
Route
TOPICAL
Labeler
Sion Biotext Medical Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-17
Substance
POVIDONE-IODINE
Active strength
.1 g/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Povidone Iodine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE.1 g/1

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
797730Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
04438f9e-302c-431b-b3ad-d2c50ca01ad8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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, Related label table
NDCEffectiveRelated label
68786-130-012020-03-18Povidone Iodine Prep Pad
68786-130-022020-03-18Povidone Iodine Prep Pad
68786-130-032020-03-18Povidone Iodine Prep Pad
68786-130-042020-03-18Povidone Iodine Prep Pad
68786-130-052020-03-18Povidone Iodine Prep Pad
68786-130-062020-03-18Povidone Iodine Prep Pad
68786-130-012020-01-31Povidone Iodine Prep Pad
68786-130-022020-01-31Povidone Iodine Prep Pad
68786-130-032020-01-31Povidone Iodine Prep Pad
68786-130-042020-01-31Povidone Iodine Prep Pad
68786-130-052020-01-31Povidone Iodine Prep Pad
68786-130-062020-01-31Povidone Iodine Prep Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-130-01Povidone Iodine50 in 1 BOXSWAB506
68786-130-01Povidone Iodine1 in 1 PACKETSWAB16
68786-130-02Povidone Iodine25 in 1 BOXSWAB256
68786-130-02Povidone Iodine3 in 1 PACKETSWAB36
68786-130-03Povidone Iodine50 in 1 BOXSWAB506
68786-130-03Povidone Iodine1 in 1 PACKETSWAB16
68786-130-04Povidone Iodine1 in 1 PACKETSWAB16
68786-130-04Povidone Iodine50 in 1 BOXSWAB506
68786-130-05Povidone Iodine3 in 1 PACKETSWAB36
68786-130-05Povidone Iodine25 in 1 BOXSWAB256
68786-130-06Povidone Iodine50 in 1 BOXSWAB506
68786-130-06Povidone Iodine1 in 1 PACKETSWAB16

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-130POVIDONE IODINE (POVIDONE-IODINE) SWAB [SION BIOTEXT MEDICAL LTD]5Current NDC, Legacy NDC, 12 package rows20240131_04438f9e-302c-431b-b3ad-d2c50ca01ad8.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 98 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dynarex GreenALCOHOLDynarex Corporation072572be-49dd-4594-bc40-b56db57ada5b2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenCHLOROXYLENOLDynarex Corporation59b098d2-08de-4fdb-a209-ae226abf37d62024-11-20WarningsExact identifier
application number: M003
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
application number: M003
Pet wipesBENZALKONIUM CHLORIDEShandong Yayun Sanitary Products Co., Ltd.2764ea79-32d8-b7f6-e063-6394a90a55012024-11-20WarningsExact identifier
application number: M003
Premium Hand SanitizerETHANOLMCKESSON MEDICAL-SURGICAL INC.a9514466-e0c6-4792-984a-9f07d94ee8872024-11-18WarningsExact identifier
application number: M003
MARVEL BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.93ed0bb4-834d-44ca-9c0a-20086fc09ab82024-11-18WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.98b0bcc2-539b-4471-ba98-bbe17bb881bd2024-11-15WarningsExact identifier
application number: M003
CVS Health Hydrogen Peroxide WipesHYDROGEN PEROXIDECVS PHARMACY, INC7a930a5e-5b69-428f-9cbb-d03dae1802952024-11-12WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine Prep PadPOVIDONE-IODINEAcme United Corporation509b6c8e-6a9f-2656-e054-00144ff8d46c2024-11-09WarningsExact identifier
application number: M003
MED NAP Cleansing ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd92cd45a-234c-4872-e053-2a95a90a3e1c2024-11-09WarningsExact identifier
application number: M003
MED NAP Obstetrical ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd83d2fab-6972-9b18-e053-2995a90a5cb52024-11-09WarningsExact identifier
application number: M003
MED NAP Benzalkonium Chloride AntisepticBENZALKONIUM CHLORIDEAcme United Corporationd7c404c1-c765-a67c-e053-2995a90a6b8e2024-11-09WarningsExact identifier
application number: M003
Barbie BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.d675eb91-80a8-4874-a2b0-c2bf692649112024-11-08WarningsExact identifier
application number: M003
Barbie ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.a4a6beb0-5781-4d74-9120-7ca64e035c232024-11-08WarningsExact identifier
application number: M003
MARVEL ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.f6cd4757-d6e0-46bd-827f-3f380c71858f2024-11-07WarningsExact identifier
application number: M003
Instant Hand SanitizerHAND SANITIZERRaining Rose, Inc.2656d129-df88-4489-e063-6394a90a4b492024-11-07WarningsExact identifier
application number: M003
HealthWise Advanced Hand SanitizerETHYL ALCOHOL 70%Veridian Healthcare261bd056-c2f9-2a69-e063-6394a90af8df2024-11-04WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber AloeORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.0588ae1b-f29a-e1b6-e063-6394a90a0de12024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber AloeETHYL ALCOHOLWhole Foods Market, Inc.074334af-c26e-4126-e063-6394a90ae4c42024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Orange BlossomORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.07f708d1-11c8-eb50-e063-6294a90a3a812024-11-02WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN04438f9e-302c-431b-b3ad-d2c50ca01ad86
797730povidone-iodine 100 MG/ML Medicated PadSCD04438f9e-302c-431b-b3ad-d2c50ca01ad86
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY04438f9e-302c-431b-b3ad-d2c50ca01ad86
797730povidone-iodine 10 % Medicated PadSY04438f9e-302c-431b-b3ad-d2c50ca01ad86
797730povidone-iodine 10 % Medicated SwabstickSY04438f9e-302c-431b-b3ad-d2c50ca01ad86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68786-130-016878601300150 PACKET in 1 BOX (68786-130-01) / 1 SWAB in 1 PACKET50 packet2013-04-170000-00-00NoNoCurrent
68786-130-026878601300225 PACKET in 1 BOX (68786-130-02) / 3 SWAB in 1 PACKET25 packet2013-04-170000-00-00NoNoCurrent
68786-130-036878601300350 PACKET in 1 BOX (68786-130-03) / 1 SWAB in 1 PACKET50 packet2013-04-170000-00-00NoNoCurrent
68786-130-046878601300450 PACKET in 1 BOX (68786-130-04) / 1 SWAB in 1 PACKET50 packet2013-04-170000-00-00NoNoCurrent
68786-130-056878601300525 PACKET in 1 BOX (68786-130-05) / 3 SWAB in 1 PACKET25 packet2013-04-170000-00-00NoNoCurrent
68786-130-066878601300650 PACKET in 1 BOX (68786-130-06) / 1 SWAB in 1 PACKET50 packet2013-04-170000-00-00NoNoCurrent