FDA.reportPublic FDA data

Povidone Iodine

Product NDC
0395-9136
11-digit product format
003959136
Labeler code
0395
Product ID
0395-9136_0c93bae9-c6ed-1fc7-e063-6394a90adea9
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine Oral Rinse 0.5%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Humco Holding Group, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-06
Substance
POVIDONE-IODINE
Active strength
5 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
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
314935Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b83dbdd1-ff63-caf8-e053-2a95a90a5764Available 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
0395-9136-23Povidone Iodine20 mL in 1 CONTAINERLIQUID204
0395-9136-98Povidone Iodine237 mL in 1 CONTAINERLIQUID2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9136POVIDONE IODINE (POVIDONE IODINE ORAL RINSE 0.5%) LIQUID [HUMCO HOLDING GROUP, INC.]4Current NDC, Legacy NDC, 2 package rows20231216_b83dbdd1-ff63-caf8-e053-2a95a90a5764.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 35 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChloraspeticMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.2b1808b2-2574-4ab8-a762-5733251848ce2024-10-25WarningsExact identifier
application number: M022
Chloraseptic Warming Sore ThroatPHENOLPrestige Brands Holdings, Inc.a197fab2-70ce-4a6c-9add-29d7368a75c52024-10-25WarningsExact identifier
application number: M022
Gly-OxideCARBAMIDE PEROXIDEMedtech Products Inc.086a0b82-e947-41c9-89e7-ba06483960c92024-10-25WarningsExact identifier
application number: M022
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.d500f423-b9f2-4d98-8f2a-8bab7c05737c2024-10-25WarningsExact identifier
application number: M022
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.b30e4b32-89dd-4e53-81d5-1415105361d42024-10-25WarningsExact identifier
application number: M022
Finafta MultiOralBENZOCAINEEfficient Laboratories Inc.28c5a993-fb5f-4091-af15-32ccae4b9a7d2024-10-14WarningsExact identifier
application number: M022
Rexall Sensitive FreshmintPOTASSIUM NITRATE, SODIUM FLUORIDEOld East Main CO.7e715bb9-666e-4de4-ba70-1c84f52434432024-10-14WarningsExact identifier
application number: M022
Rexall Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDEOld East Main CO.2daf18a3-f71e-4585-8128-4663eff7eb6d2024-10-14WarningsExact identifier
application number: M022
Anadent Kanka GelBENZOCAINEBELMORA LLCe0f73d78-5db1-43b4-8f58-e5410ca4560f2024-10-04WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLNavajo Manufacturing Company Inc.f5f26e2f-8a1f-4687-e053-2a95a90ae3782024-10-03WarningsExact identifier
application number: M022
Colgate Great Regular FlavorSODIUM MONOFLUOROPHOSPHATENavajo Manufacturing Company Inc.f89bf259-b738-8229-e053-6394a90a0c592024-10-03WarningsExact identifier
application number: M022
Colgate Total SF Clean MintSTANNOUS FLUORIDENavajo Manufacturing Company Inc.f71c53e0-e2dd-16f9-e053-6394a90accff2024-10-03WarningsExact identifier
application number: M022
Crest Pro HealthCETYLPYRIDINIUM CHLORIDENavajo Manufacturing Company Inc.65bf17a9-21ad-27cb-e053-2991aa0afc402024-10-02WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening AdvancedPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC94e07979-943b-45bb-8e2b-90d686f3692e2024-09-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Advanced PlusPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC6eb304dd-2a24-4fa0-9d39-71264e88dd162024-08-29WarningsExact identifier
application number: M022
Sensodyne Pronamel Clinical Enamel Strength Deep CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcfda7efa-86fa-470d-a79f-81907e31778a2024-08-14WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Bubble TwistSODIUM FLUORIDEHaleon US Holdings LLCe403529a-0fac-4dab-b75c-46906add096b2024-08-13WarningsExact identifier
application number: M022
Calcium Carbonate Assorted FlavorsANTACID TABLETSNuCare Pharmaceuticals,Inc.af10dfb6-fef3-3410-e053-2995a90a91302024-07-17WarningsExact identifier
application number: M022
SENSODYNE Advanced Whitening PlusPOTASSIUM NITRATEHaleon US Holdings LLCf757ccdd-b316-4799-a34a-10edbb73da6b2024-07-12WarningsExact identifier
application number: M022
dentalux SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE, SODIUM FLUORIDELidl US, LLCbaef7f15-8082-4e61-8c08-8beda8ad40c02024-07-03WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314935povidone-iodine 0.5 % MouthwashPSNb83dbdd1-ff63-caf8-e053-2a95a90a57644
314935povidone-iodine 5 MG/ML MouthwashSCDb83dbdd1-ff63-caf8-e053-2a95a90a57644
314935povidone-iodine 0.5 % MouthwashSYb83dbdd1-ff63-caf8-e053-2a95a90a57644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-9136-230039591362320 mL in 1 CONTAINER (0395-9136-23) 20 ml2021-10-010000-00-00NoNoCurrent
0395-9136-9800395913698237 mL in 1 CONTAINER (0395-9136-98) 237 ml2021-01-060000-00-00NoNoCurrent