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 55 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Hand Sanitizer Sweet PeaALCOHOLShenzhen Lantern Scicence Co.,Ltd.435ca082-0b6b-c55e-e063-6294a90af56e2025-11-11WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.435d514e-204a-118b-e063-6294a90aa8a62025-11-11WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Spider-manALCOHOLShenzhen Lantern Scicence Co.,Ltd.435d939c-9bef-bf86-e063-6394a90a41422025-11-11WarningsExact identifier
application number: M003
Foaming Hand SanitizerHAND SANITIZERAmerican Chemical Systems II, LLC3085d595-68b7-4100-81c0-f0699a7609d62025-11-10WarningsExact identifier
application number: M003
Genuine First Aid Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.48867a79-4d21-4ba1-9cf9-7839352a4b7e2025-11-07WarningsExact identifier
application number: M003
Pocket NurseISOPROPYL ALCOHOLPocket Nurse Enterprises, LLC42ded32e-15d9-8b03-e063-6394a90ad6bc2025-11-06WarningsExact identifier
application number: M003
SMARTIES ORANGE HAND SANITIZER MIX BERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d5785f-a86b-47fb-e063-6294a90a73142025-11-05WarningsExact identifier
application number: M003
Sour Patch Kids Hand Sanitizer Blue RaspberryALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d5afab-e872-09e3-e063-6394a90abcc42025-11-05WarningsExact identifier
application number: M003
DASIY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d632d1-17a9-b4cf-e063-6394a90a84682025-11-05WarningsExact identifier
application number: M003
DASIY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d677a4-3cc2-a039-e063-6294a90a16722025-11-05WarningsExact identifier
application number: M003
Pain Relieving CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HCLTARGET CORPORATION944b3f78-3efa-484b-84f0-00ffe95c5dfb2025-11-05WarningsExact identifier
application number: M003
Hand SanitizerSDA 40B ALCOHOL 200 PROOFTropical Seas, Inc.b48f9afa-1634-e63e-e053-2a95a90a32bf2025-11-04WarningsExact identifier
application number: M003
Smarties Orange Hand Sanitizer Raspberry CreamALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d22dff-dca4-ead3-e063-6394a90abdce2025-11-04WarningsExact identifier
application number: M003
Smarties Hand Sanitizer Orange CreamsicleALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d1fdb7-0cae-edce-e063-6294a90a9a962025-11-04WarningsExact identifier
application number: M003
MyHealth Alcohol Antiseptic Hand SanitizerALCOHOLAeroflex Industria de Aerosol Ltdaf8eeb819-ec48-41a4-920c-7cdae55d7ecd2025-10-31WarningsExact identifier
application number: M003
MyHealth Advanced Hand SanitizerALCOHOLAeroflex Industria de Aerosol Ltda0e3b2c36-57d7-438b-a2fc-fa9f00d9a5522025-10-31WarningsExact identifier
application number: M003
Nourishing Hand Sanitizer Orange CorianderALCOHOL SOLUTIONNoshinku2fed43e6-cf3a-bf33-e063-6394a90a16cf2025-10-31WarningsExact identifier
application number: M003
Coralite Antibacterial MoistBENZALKONIUM CHLORIDEUnited Exchange Corp.6245a83f-5c81-4ae6-bc6e-adfc46c370032025-10-31WarningsExact identifier
application number: M003
Castellani PaintPHENOLStratus Pharamceuticals74192c0e-3c73-4ab0-96d1-1917cbd6777a2025-10-30WarningsExact identifier
application number: M003
GrowDefender Antibacterial FoamANTIBACTERIAL FOAMGrow Defender LLC423af3d9-6413-c097-e063-6294a90ae1a92025-10-28WarningsExact 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