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 11 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humco Gentian Violet 2%GENTIAN VIOLET 2%Humco Holding Group, Inc.a07f61e5-0215-419a-a68a-1d814417c35f2026-07-09WarningsExact identifier
application number: M003
GNP Gentian Violet 1%GENTIAN VIOLET 1%Amerrisource Bergen5d07274f-e848-6c60-e053-2991aa0a40d82026-07-09WarningsExact identifier
application number: M003
Drs pharmacy triple antibiotic Pain plus itch plus ScarBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLC16273878-2f58-0d26-e063-6394a90a47d22026-07-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic Plus Pain reliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACY1626fa89-cec0-6467-e063-6294a90aa2a42026-07-09WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC56148c12-7d6f-26bf-e063-6294a90a93df2026-07-08WarningsExact identifier
application number: M003
Povidone-IodinePOVIDONE-IODINECARDINAL HEALTH 110, LLC. DBA LEADER4f0d8da5-a75b-acc7-e063-6394a90ae8392026-07-08WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5600cf8a-5aba-1a22-e063-6394a90a80832026-07-07WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink SugarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5600dc30-192d-19b1-e063-6394a90a66d32026-07-07WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLSave-A-Lot Food Stores Ltda592326c-c062-4ebf-b8dd-83f7e6f2f22b2026-07-07Warnings, Adverse reactionsExact identifier
application number: M003
Amazon Basics Citrus Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC52e5b1a4-3a84-c4cb-e063-6394a90a822c2026-07-07WarningsExact identifier
application number: M003
Amazon Basics Fresh Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC5256f38a-74b6-0d18-e063-6294a90a5b462026-07-07WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLEverywhereAire LLCb48f9e6b-c616-3607-e053-2995a90a37f52026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands hand sanitizerETHYL ALCOHOLEverywhereAire LLCb6af3009-78c2-2312-e053-2995a90af90a2026-07-06WarningsExact identifier
application number: M003
Hand Sanitizer gelALCOHOLEverywhereAire LLCd2a6c866-3f1e-20f1-e053-2995a90a26cc2026-07-06WarningsExact identifier
application number: M003
PlaneAire HandsHAND SANITIZER ETHANOL-BASEDEverywhereAire LLCeab3ab67-cb27-6c2b-e053-2a95a90ace122026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands SandalwoodETHANOL HAND SANITIZEREverywhereAire LLC18612a10-8667-b0ef-e063-6394a90a208e2026-07-06WarningsExact identifier
application number: M003
PlaneAire HandsETHANOL HAND SANITIZEREverywhereAire LLCb86824c2-4fae-d597-e053-2995a90ad1da2026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands Lemon Olive Oil Hand SanitizerETHANOL HAND SANITIZEREverywhereAire LLC42f8c2fb-a4e6-9416-e063-6294a90af9d52026-07-06WarningsExact identifier
application number: M003
PlaneAire HandsHAND SANITIZER ETHANOL BASEDEverywhereAire LLceab52ae1-f588-b08b-e053-2995a90a96b22026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands hand sanitizerHAND SANITIZER ETHANOL-BASEDEverywhereAire LLCeab19649-21fc-2fa4-e053-2995a90a90f92026-07-06WarningsExact 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