FDA.reportPublic FDA data

Povidone Iodine

Product NDC
82645-907
11-digit product format
826450907
Labeler code
82645
Product ID
82645-907_0d1cde4b-4305-9c0b-e063-6394a90ac843
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine 10%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharma Nobis, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Substance
POVIDONE-IODINE
Active strength
100 mg/mL
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-IODINE100 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
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
e42eee1b-3539-fb17-e053-2995a90af61dAvailable 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
82645-907-16Povidone Iodine473 mL in 1 BOTTLE, PLASTICLIQUID4733
82645-907-96Povidone Iodine177 mL in 1 BOTTLE, PLASTICLIQUID1773
82645-907-98Povidone Iodine237 mL in 1 BOTTLE, PLASTICLIQUID2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-907POVIDONE IODINE (POVIDONE IODINE 10%) LIQUID [PHARMA NOBIS, LLC]3Current NDC, Legacy NDC, 3 package rows20231223_e42eee1b-3539-fb17-e053-2995a90af61d.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
312564povidone-iodine 10 % Topical SolutionPSNe42eee1b-3539-fb17-e053-2995a90af61d3
312564povidone-iodine 100 MG/ML Topical SolutionSCDe42eee1b-3539-fb17-e053-2995a90af61d3
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYe42eee1b-3539-fb17-e053-2995a90af61d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82645-907-1682645090716473 mL in 1 BOTTLE, PLASTIC (82645-907-16) 473 ml2017-11-140000-00-00NoNoCurrent
82645-907-9682645090796177 mL in 1 BOTTLE, PLASTIC (82645-907-96) 177 ml2022-12-190000-00-00NoNoCurrent
82645-907-9882645090798237 mL in 1 BOTTLE, PLASTIC (82645-907-98) 237 ml2017-11-140000-00-00NoNoCurrent