FDA.reportPublic FDA data

Povidone Iodine

Product NDC
24385-053
11-digit product format
243850053
Labeler code
24385
Product ID
24385-053_5370a9db-deae-fad0-e063-6394a90a616b
Type
HUMAN OTC DRUG
Nonproprietary name
povidone-iodine
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Amerisource Bergen
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-02-01
Marketing end
2026-12-01
Substance
POVIDONE-IODINE
Active strength
.1 g/mL
NDC exclude flag
No
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct24385-053IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage24385-05324385-053-55IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE.1 g/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
f69a5cec-04f2-4028-94c6-1f129d2de5a9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24385-053-552020-03-17C16284748780-1956f9ecf-ce5b-621f-e053-dbdaa90a74adGNP Povidone Iodine
24385-053-552019-10-21C16284748780-1956f9ecf-ce5b-621f-e053-dbdaa90a74adGNP Povidone Iodine

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-053-55ML - Milliliter24385-05334e4bcb9-fdcf-48f3-974a-359e2d1c0c8012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
povidone-iodineACTIVE INGREDIENT85H0HZU99MPOVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]2
povidone-iodineACTIVE MOIETY85H0HZU99MPOVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPPOVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXPOVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IPOVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]2
waterINACTIVE INGREDIENT059QF0KO0RPOVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-053POVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]5Current NDC, Legacy NDC20231215_f69a5cec-04f2-4028-94c6-1f129d2de5a9.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 67 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ECOLAB AntisepticBENZALKONIUM CHLORIDEEcolab Food Safety Specialties, Inc.933860e7-5a1f-453a-e053-2995a90a49022025-09-09WarningsExact identifier
application number: M003
ECOLAB Burn CreamBENZAALKONIUM CHLORIDE, LIDOCAINE HCLECOLAB Food Safety Specialties, Inc.4b2a7da9-c0e9-61c5-e054-00144ff8d46c2025-09-09WarningsExact identifier
application number: M003
ECOLAB AntisepticBENZALKONIUM CHLORIDE 0.13%ECOLAB Food Safety and Specialties, Inc.4c982e7b-2489-151f-e054-00144ff88e882025-09-09WarningsExact identifier
application number: M003
Thompson AntisepticBENZALKONIUM CHLORIDEThompsonf537c81d-1fdc-3e0f-e053-2a95a90a6c2b2025-09-09WarningsExact identifier
application number: M003
MedlineBENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDEMedline Industries, LPb0b5ff82-db36-7708-e053-2a95a90ad9bb2025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Champagne AppleETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6ad099-c770-064f-e063-6294a90a222d2025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CascadeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef24-f162-5549-e063-6294a90a30b82025-09-09WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Caramel CinnamonETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef38-215c-defa-e063-6394a90a46a62025-09-09WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer CrayolaALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e44c28e-c6ed-52b4-e063-6394a90a9dd02025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer My Little PonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e45fe7d-b30c-9273-e063-6294a90ae8e12025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer Peppa pigALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e466475-351f-614e-e063-6394a90ab25a2025-09-08WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e46fe11-247f-36ad-e063-6294a90a1dd42025-09-08WarningsExact identifier
application number: M003
Green Guard Super Stat Blood Clotting First AidBENZETHONIUM CHLORIDE AND LIDOCAINEUnifirst First Aid Corporation47355df2-de67-4cf9-b367-645228e494ce2025-09-08WarningsExact identifier
application number: M003
Blood Clotting First AidBENZETHONIUM CHLORIDE AND LIDOCAINEUnifirst First Aid Corporation2e544963-aa49-49cd-837e-9d89d86e257f2025-09-08WarningsExact identifier
application number: M003
Medi-first Protective Coating BandageBENZETHONIUM CHLORIDE AND BENZOCAINEUnifirst First Aid Corporation05b0aef9-1553-4e95-8798-f41e5999bb462025-09-08WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporation3f7fb451-e701-4aa8-814e-ceeb5c2198d92025-09-08WarningsExact identifier
application number: M003
Medi-First Plus Alcohol Wipes70% ISOPROPYL ALCOHOLUnifirst First Aid Corporation3f507990-282a-4b26-e054-00144ff8d46c2025-09-08WarningsExact identifier
application number: M003
Green Guard Sterile Alcohol WipesISOPROPYL ALCOHOL 70%Unifirst First Aid Corporation570baa70-e519-328b-e054-00144ff8d46c2025-09-08WarningsExact identifier
application number: M003
Medi-First Plus Antiseptic WipesBENZALKONIUM CHLORIDEUnifirst First Aid Corporation5743634b-f329-5fec-e053-2991aa0a751d2025-09-08WarningsExact identifier
application number: M003
Green Guard Antiseptic WipesBENZALKONIUM CHLORIDEUniFirst First Aid Corporation1bdd57c3-cdaf-a085-e063-6394a90a1e3d2025-09-08WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24385-053-5524385005355236 mL in 1 BOTTLE (24385-053-55) 236 ml2005-02-012026-12-01NoNoCurrent