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 106 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XtraCare Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International	a339dfd9-7cb8-4198-bc2a-9759648cf34e	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International	f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72	2024-02-28	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd	11ef87cc-6ff6-511b-e063-6294a90a662f	2024-02-21	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER	ETHYL ALCOHOL	MY IMPORTS USA LLC	11f19126-6abb-b14c-e063-6294a90a4e34	2024-02-21	Warnings	Exact identifier application number: M003
Antiseptic	ANTISEPTIC SPRAY	Dynarex Corporation	118192ac-7173-09c5-e063-6394a90ad550	2024-02-16	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL SPRAY	Dynarex Corporation	116e0c9c-cbe0-bf67-e063-6394a90ae530	2024-02-15	Warnings	Exact identifier application number: M003
POVIDONE-IODINE	POVIDONE-IODINE	HART Health	92b6a38e-c7bb-45e2-9c2a-7993ed1bac36	2024-02-15	Warnings	Exact identifier application number: M003
Povidone Iodine Gel Swabstick	POVIDONE IODINE GEL SWABSTICK	Dynarex Corporation	eb7e21be-521e-2d52-e053-2a95a90ade33	2024-02-13	Warnings	Exact identifier application number: M003
Antiseptic	ALCOHOL, LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	71aeaf86-2b4d-4945-9606-a9db0ab6b726	2024-02-07	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE, BENZOCAINE	Safetec of America, Inc.	458e65f2-826d-4550-8c7d-17add2d7ba9a	2024-02-07	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Safetec of America, Inc.	a665e2ce-c7e1-4d79-aa58-da7595944e7f	2024-02-07	Warnings	Exact identifier application number: M003
First Aid and Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	47cb6921-5d82-4123-a9e0-0b05d4dcb5b2	2024-02-07	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with vitamin E	ETHYL ALCOHOL 70%V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	0fbf0078-3660-fe5c-e063-6394a90afc2d	2024-01-25	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with aloe vera	ETHYL ALCOHOL 70%V/V	Midwood Brands, LLC	0fc032af-26bc-0e8b-e063-6294a90a91b0	2024-01-25	Warnings	Exact identifier application number: M003
Hand sanitizer 16.9oz with vitamin E	ETHYL ALCOHOL	Midwood Brands, LLC	0fc0bd79-ddd7-b9d1-e063-6394a90adc69	2024-01-25	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with vitamin E	ETHYL ALCOHOL 70%V/V	Midwood Brands, LLC	0fc0970d-06a6-ade9-e063-6394a90ae7ff	2024-01-25	Warnings	Exact identifier application number: M003
Target Up and Up Pain Relieving Cleansing	BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	TARGET CORPORATION	0f964747-be02-c715-e063-6294a90ad91e	2024-01-25	Warnings	Exact identifier application number: M003
SannyTize Hand Sanitizer	HAND SANITIZER	Dynarex Corporation	968713a5-64d3-86fc-e053-2995a90a088a	2024-01-24	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with aloe vera	ETHYL ALCOHOL 70%V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	0fbd6962-59e6-7230-e063-6394a90afd8e	2024-01-24	Warnings	Exact identifier application number: M003
Cold Sore Treatment, 24-7 Life by 7-Eleven	BENZALKONIUM CHLORIDE	Lil' Drug Store Products, Inc.	0f4fb868-1462-f88e-e063-6394a90a69e4	2024-01-19	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