Povidone Iodine

Product NDC: 0395-9129
11-digit product format: 003959129
Labeler code: 0395
Product ID: 0395-9129_0c9368f8-3986-07dd-e063-6394a90ac66a
Type: HUMAN OTC DRUG
Nonproprietary name: Povidone-Iodine Spray 5%
Dosage form: LIQUID
Route: TOPICAL
Labeler: Humco Holding Group, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-01-23
Substance: POVIDONE-IODINE
Active strength: 50 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE-IODINE	50 mg/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
238850	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
a7bb80c4-bbc0-21ea-e053-2995a90a52c1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-9129-93	Povidone Iodine	89 mL in 1 CONTAINER	LIQUID	89		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-9129	POVIDONE IODINE (POVIDONE-IODINE SPRAY 5%) LIQUID [HUMCO HOLDING GROUP, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20231216_a7bb80c4-bbc0-21ea-e053-2995a90a52c1.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 107 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Medi-First Burn with Lidocaine	BENZALKONIUM CHLORIDE, LIDOCAINE	Unifirst First Aid Corporation	bd46efc8-0b36-0931-e053-2a95a90adb6f	2024-01-17	Warnings	Exact identifier application number: M003
Green Guard Antiseptic	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	bc914c36-e0f0-18c5-e053-2a95a90a894e	2024-01-17	Warnings	Exact identifier application number: M003
Medi-First Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	bca2b641-7fbc-5462-e053-2995a90ae2b4	2024-01-17	Warnings	Exact identifier application number: M003
Medi-First Isopropyl Alcohol 70%	ISOPROPYL ALCOHOL	Unifirst First Aid Corporation	dbeac2f5-b897-5e71-e053-2995a90a7549	2024-01-17	Warnings	Exact identifier application number: M003
Green Guard Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	bca4545e-d477-270a-e053-2995a90a0ed6	2024-01-17	Warnings	Exact identifier application number: M003
MyMedic Calendula Gel	CALENDULA OFFICINALIS FLOWER	Nantong Health & Beyond Hygienic Products Inc.	0f0aa235-ac35-ac91-e063-6394a90a73fc	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Oral Pain Relief Gel	BENZOCAINE	Nantong Health & Beyond Hygienic Products Inc.	0f0b6157-ec18-13ef-e063-6294a90a2e0c	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Super Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	0f0c535d-8ff3-4799-e063-6394a90a7063	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	0f0d1ba7-fe9c-8e0b-e063-6394a90a3081	2024-01-16	Warnings	Exact identifier application number: M003
White Petrolatum	WHITE PETROLATUM	Nantong Health & Beyond Hygienic Products Inc.	0f0d6ff0-ff30-aaf8-e063-6394a90a2716	2024-01-16	Warnings	Exact identifier application number: M003
Thompson Hand Sanitizer	ETHYL ALCOHOL	Thompson	deada606-8a82-9eeb-e053-2a95a90a9e6d	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Arnica Gel	ARNICA MONTANA	Nantong Health & Beyond Hygienic Products Inc.	0ef8760d-27c0-7ece-e063-6294a90a6873	2024-01-15	Warnings	Exact identifier application number: M003
American Safety First Aid Antispetic	HYDROGEN PEROXIDE	Orazen Inc	ea2fbdfe-1932-9fb4-e053-2a95a90a3563	2024-01-15	Warnings	Exact identifier application number: M003
First Aid Antispetic	BENZALKONIUM CHLORIDE	Orazen Inc	ea2debcb-892c-339f-e053-2a95a90a4b18	2024-01-15	Warnings	Exact identifier application number: M003
Ever Ready First Aid	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Ever Ready First Aid	e53f3bf5-25c0-2b86-e053-2a95a90a010f	2024-01-15	Warnings	Exact identifier application number: M003
FIRST SHIELD First Aid Antiseptic	BENZALKONIUM CHLORIDE	Ever Ready First Aid	e013ef0a-ef3d-7af5-e053-2a95a90a54d3	2024-01-15	Warnings	Exact identifier application number: M003
Latalia Hand Sanitizer 80 Alcohol Antiseptic	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD	ae55fab3-3177-383e-e053-2995a90a17a0	2024-01-10	Warnings	Exact identifier application number: M003
Latalia Sanitizing Wipe	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD	ae564635-898e-fbf6-e053-2995a90a8119	2024-01-10	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238850	povidone-iodine 5 % Topical Spray	PSN	a7bb80c4-bbc0-21ea-e053-2995a90a52c1	4
238850	povidone-iodine 50 MG/ML Topical Spray	SCD	a7bb80c4-bbc0-21ea-e053-2995a90a52c1	4
238850	povidone-iodine 5 % Topical Spray	SY	a7bb80c4-bbc0-21ea-e053-2995a90a52c1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0395-9129-93	00395912993	89 mL in 1 CONTAINER (0395-9129-93)	89 ml	2020-01-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Private Label Povidone Iodine Spray 5%	Humco Holding Group, Inc. \| Pharma Nobis, LLC	2023-12-15	HUMAN OTC DRUG LABEL	4