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 57 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Soft BerryETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce569-f2d3-c1e0-e063-6294a90a822f2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER BLUE RASPBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d1f66d-45f6-bb9a-e063-6394a90a06aa2025-10-26WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLCardinal Healthc95bfab6-bab4-79f3-e053-2995a90a80912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6e97d7-7eea-f7ca-e063-6394a90a4ecd2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6cabf7-9310-cba5-e063-6394a90a3f912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC39529f87-ed4e-52b8-e063-6394a90af8792025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLPhoenix Healthcare Solutions LLCf0b55f6c-4afd-2154-e053-2995a90afcfa2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe8cdf841-cf56-26cc-e053-2995a90aab512025-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLCc17603f2-3548-4225-b611-216c2763e51f2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc601d9ea-25ab-cd1d-e053-2995a90ae2522025-10-23WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCardinal Healthcc0a6e1e-ec95-cb48-e053-2a95a90ac0ce2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions, LLCd07d103d-420b-5307-e053-2995a90a14f52025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHtl-Strefa, Inc.d72ddf5a-72e7-c37d-e053-2995a90ad48b2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc92524fd-8b91-592d-e053-2a95a90a88c62025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLCardinal Health89852887-ae62-4277-b615-75663afb54362025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.b9826baa-b976-14c6-e053-2995a90a7d092025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc9261c7f-9f8f-6476-e053-2a95a90a0e932025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLRugby Laboratoriesea28b27a-456e-4042-b769-f060727599332025-10-23WarningsExact identifier
application number: M003
School Health Sterile Alcohol Prep PadISOPROPYL ALCOHOLSchool Health Corporation718640e1-826b-4b65-a021-3f82cd4c983a2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.215fa8ac-c9b6-42b6-ae9d-a08d7ff0900f2025-10-23WarningsExact 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