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#

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 105 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC1308ce91-2858-310a-e063-6394a90a68102024-03-06WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Cocoa ButterETHYL ALCOHOLRejoice International, Inc.97dee45e-53be-4b37-a427-fc24388c0e052024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer Aloe VeraETHYL ALCOHOLRejoice International, Inc.1e28454c-f5d8-4d6e-91f9-bc4501b027c12024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - ClearETHYL ALCOHOLRejoice International, Inc.f0e637d9-d61e-466d-9e05-f906639dbaca2024-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International, Inc.07b163e4-8f67-44e7-b5ef-f237023080e02024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Ice ClearETHYL ALCOHOLRejoice International, Inc.605ec88a-2f4c-4716-8522-eb2748b433982024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - OriginalETHYL ALCOHOLRejoice International, Inc.bb9cc886-275e-4996-99dc-529f928b49052024-02-28WarningsExact identifier
application number: M003
Liquid Hand CleanseTRICLOSANRejoice International, Inc.23ff5450-8308-41c0-9052-1ac4c4433d6c2024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse OriginalTRICLOSANRejoice International, Inc.b5ce6663-fe82-4da1-923e-acea293d7a002024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse Strawberry PomegranateTRICLOSANRejoice International, Inc.b68a7d64-2650-4fc6-a89e-05de9098a2a32024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse Mountain SpringTRICLOSANRejoice International, Inc.c31723d5-a313-448a-8b69-ca5f8dec25ed2024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice Internationala9a1467c-abcc-4ccb-88f6-4302796097882024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry BlossomBENZALKONIUM CHLORIDERejoice International9fa9d955-7167-4a0a-935b-2a600f439eb02024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion FlowerBENZALKONIUM CHLORIDERejoice International157a14bf-f46e-49f8-96f4-a6c472eb5cb82024-02-28WarningsExact identifier
application number: M003
XtraCare Foaming Hand SanitizerBENZALKONIUM CHLORIDERejoice International3082cbbb-a0ed-45eb-a116-ad1c65357dd12024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry BlastBENZALKONIUM CHLORIDERejoice International45b3ca49-edb4-4840-b857-d24045494a3a2024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Vanilla Passion FlowerBENZALKONIUM CHLORIDERejoice International4890f81e-7994-4ea2-9412-5614c405a2a32024-02-28WarningsExact identifier
application number: M003
XtraCare Foam Antibacterial Hand Wash Wild Berry BlastBENZALKONIUM CHLORIDERejoice International5c109f7c-1f4d-484a-b6ea-3bbcf572bbac2024-02-28WarningsExact identifier
application number: M003
XtraCare Hand Sanitizer Moisurize with Vitamin E and AloeETHYL ALCOHOLRejoice International2851ad2a-e108-424c-86d6-c898567695ef2024-02-28WarningsExact identifier
application number: M003
XtraCare Hand Sanitizer Moisturize with Vitamin EETHYL ALCOHOLRejoice International13c99570-0859-4310-843a-5eb266698eb32024-02-28WarningsExact 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