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 108 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Northside Hospital Amenity Kit--GI DeptALCOHOLASP Global, LLcc284eba4-0b92-4981-b3f8-d8d99b58bdfd2024-01-10WarningsExact identifier
application number: M003
Meijer 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDEMeijer, Inc.33143d87-3e57-4a17-a96c-b699ad034b5b2024-01-09WarningsExact identifier
application number: M003
Meijer 70 Isopropyl Alcohol Wipes First Aid AntisepticISOPROPYL ALCOHOLMeijer, Inc2046162f-cb70-416c-ae37-14999883a8072024-01-09WarningsExact identifier
application number: M003
Lightning X AntisepticBENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0e6b10e7-6e84-6bfc-e063-6294a90a85372024-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDE 3.0%Trifecta Pharmaceuticals USA, LLC.e4e45f11-7cd4-e693-e053-2a95a90a4c342024-01-02WarningsExact identifier
application number: M003
GLOBAL CARE GOLD ANTIBACTERIAL HANDBENZALKONIUM CHLORIDENINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.27ba0f30-e066-f240-e063-6394a90ae7cb2024-01-01WarningsExact identifier
application number: M003
Freskaro Decolorized IodineALCOHOLPharma Nobis, LLCfbd222a2-1151-99b9-e053-6394a90a8bb82023-12-28WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLTopco Associates65270825-48b1-49e7-a14e-f73df9beb9dd2023-12-27WarningsExact identifier
application number: M003
Humco Hydrogen PeroxideHYDROGEN PEROXIDE 3%Pharma Nobis, LLCe42f876d-0477-c4d5-e053-2a95a90ae6d42023-12-26WarningsExact identifier
application number: M003
Ethyl Rubbing Alcohol 70 PercentETHYL ALCOHOLPharma Nobis, LLCe42fccc2-1b50-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M003
Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e1-02c6-e053-2995a90a3ace2023-12-26WarningsExact identifier
application number: M003
CVS MerthiolateBENZALKONIUM CHLORIDECVS Pharmacydd498ab1-8350-41aa-86fc-2db57005f3e22023-12-22WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE 10%Pharma Nobis, LLCe42eee1b-3539-fb17-e053-2995a90af61d2023-12-22WarningsExact identifier
application number: M003
Decolorized IodineETHYL ALCOHOLPharma Nobis, LLCe21dd43b-3712-cb16-e053-2a95a90ac2762023-12-22WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70 PercentISOPROPYL ALCOHOLPharma Nobis, LLCe42f727c-beb0-fe9d-e053-2995a90aafea2023-12-22WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Pharma Nobis, LLCe42ee827-b350-7b56-e053-2a95a90a69cf2023-12-22WarningsExact identifier
application number: M003
MerthiolateBENZALKONIUM CHLORIDEPharma Nobis, LLCe42f727c-beaf-fe9d-e053-2995a90aafea2023-12-22WarningsExact identifier
application number: M003
Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e0-02c6-e053-2995a90a3ace2023-12-22WarningsExact identifier
application number: M003
RevitaDERM Wound CareBENZALKONIUM CHLORIDEBlaine Labs Inc.9254dada-4e32-43a0-892b-c488d68e23e72023-12-21WarningsExact identifier
application number: M003
NUMSTAT Antiseptic and Pain Relieving Prep PadALCOHOL, MENTHOL, AND BENZOCAINE PREP PADSpectra Medical Devices, LLC07d20040-9dd9-0aba-e063-6294a90ab7cf2023-12-20WarningsExact 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