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 date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	24385-053		I	Inactivated by FDA		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	24385-053	24385-053-55	I	Inactivated by FDA		excluded / ndc_excluded.zip	`110d247fa046…`	`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
Ingredient	Strength
POVIDONE-IODINE	.1 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
85H0HZU99M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312564	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f69a5cec-04f2-4028-94c6-1f129d2de5a9	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24385-053-55	2020-03-17	C162847	48780-1	956f9ecf-ce5b-621f-e053-dbdaa90a74ad	GNP Povidone Iodine
24385-053-55	2019-10-21	C162847	48780-1	956f9ecf-ce5b-621f-e053-dbdaa90a74ad	GNP Povidone Iodine

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24385-053-55	ML - Milliliter	24385-053	34e4bcb9-fdcf-48f3-974a-359e2d1c0c80	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
povidone-iodine	ACTIVE INGREDIENT	85H0HZU99M	POVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]	2
povidone-iodine	ACTIVE MOIETY	85H0HZU99M	POVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]	2
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	POVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	POVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	POVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]	2
water	INACTIVE INGREDIENT	059QF0KO0R	POVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24385-053	POVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]	5	Current NDC, Legacy NDC	20231215_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 96 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DK12 Shower Gel Fresh Energy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	05e4ff0e-ef63-ef3b-e063-6294a90aa2b8	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Vitamin E Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe9270c0-bf6b-f0ff-e053-6394a90ae8f1	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Creamy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e2e51b-212b-368e-e063-6294a90a871c	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Fresh Energy Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe80635d-9594-abf3-e053-6394a90aa78b	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Shower Gel Creamy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	05e36111-ed4e-12de-e063-6294a90af639	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Creamy Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe7fde7e-82fc-c13f-e053-6394a90aff68	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Oatmeal Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe16387b-1b16-1f41-e053-6294a90ae2c0	2024-12-02	Warnings	Exact identifier application number: M003
First Aid Antiseptic Isopropyl Alcohol Pad	ISOPROPYL ALCOHOL	Fourstar Group USA, Inc.	27edf5dc-3e68-bdd0-e063-6394a90ac485	2024-11-27	Warnings	Exact identifier application number: M003
MicroKlenz Antimicrobial	BENZETHONIUM CHLORIDE	Medline Industries, LP	115dda08-709c-490a-9693-419b51441960	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic Pad	ALCOHOL PAD	Acme United Corporation	55421010-d806-4ca4-e054-00144ff88e88	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Hydrogen Peroxide 3%	HYDROGEN PEROXIDE	Acme United Corporationn	f1db8929-9b95-0d6e-e053-2995a90a817f	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL	Acme United Corporation	d71047f6-1353-c758-e053-2995a90a962c	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic Pad	ISOPROPYL ALCOHOL	Acme United Coporation	a01fec1b-1339-40b9-e053-2995a90aeda5	2024-11-23	Warnings	Exact identifier application number: M003
Med-Nap Sterile Alcohol Prep Pads	ISOPROPYL ALCOHOL	Acme United Corporation	c6eff57b-d537-69c8-e053-2a95a90adc3a	2024-11-23	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic	ISOPROPYL ALCOHOL	Acme United Corporation	a810e723-ad0c-8c71-e053-2995a90a0acc	2024-11-23	Warnings	Exact identifier application number: M003
Universal 50% Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	0dcc9bd2-aea5-4c27-9956-47d56221726b	2024-11-22	Warnings	Exact identifier application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and Glycerin	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	9a9d42ad-79d5-4acc-b5d9-cb7468961d47	2024-11-22	Warnings	Exact identifier application number: M003
Universal 50% Rubbing Alcohol with Wintergreen and Glycerin	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	044a6287-f568-4cfa-a813-7fc0e6ffc352	2024-11-22	Warnings	Exact identifier application number: M003
NEXXGEN 70% RUBBING ALCOHOL	ISOPROPYL ALCOHOL	A & A Nexxgen LLC	ce73ac48-c5af-4a35-950c-62ff0232aa30	2024-11-22	Warnings	Exact identifier application number: M003
Universal 70% Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	d8b9b0e7-2cb8-4fc5-af55-790e64d6cfe8	2024-11-22	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
85H0HZU99M	POVIDONE-IODINE	25655-41-8	POVIDONE-IODINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24385-053-55	24385005355	236 mL in 1 BOTTLE (24385-053-55)	236 ml	2005-02-01	2026-12-01	No	No	Current