Povidone Iodine

Product NDC: 69396-112
11-digit product format: 693960112
Labeler code: 69396
Product ID: 69396-112_29b3ae6b-a09b-f62c-e063-6294a90a150b
Type: HUMAN OTC DRUG
Nonproprietary name: Povidone Iodine 10%
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Trifecta Pharmaceuticals USA LLC
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-12-23
Substance: POVIDONE-IODINE
Active strength: 100 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE-IODINE	100 mg/g

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
312563	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
f80ccd8a-9b9b-bbf9-e053-6394a90ac827	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
69396-112-20	Povidone Iodine	1 in 1 BOX	OINTMENT	1		2
69396-112-20	Povidone Iodine	28.3 g in 1 TUBE	OINTMENT	28.3		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-112	POVIDONE IODINE (POVIDONE IODINE 10%) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]	2	Current NDC, 2 package rows	20241222_f80ccd8a-9b9b-bbf9-e053-6394a90ac827.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 93 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RUBBING ALCOHOL	ALCOHOL	INTERNATIONAL GENERAL TRADING CORP	bd5ee961-1d64-0d9d-e053-2a95a90a6010	2024-12-18	Warnings	Exact identifier application number: M003
70% Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	SZY Holdings, LLC dba EverReady First Aid	1e39b0f4-66d1-47ac-aed6-d6ac019888ce	2024-12-18	Warnings	Exact identifier application number: M003
RUBBING ALCOHOL	ALCOHOL	INTERNATIONAL GENERAL TRADING CORP	bd5eb0df-cd2d-691c-e053-2995a90a2511	2024-12-18	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol 70%	ISOPROPYL ALCOHOL	First Aid Research Corp.	7d1c0382-31b3-48d0-a514-c5cc45a2299e	2024-12-18	Warnings	Exact identifier application number: M003
First Aid Only First Aid-Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Acme United Corporation	f31a44ff-e4ac-de1e-e053-2a95a90ab036	2024-12-18	Warnings	Exact identifier application number: M003
Hand Sanitizer (Lavender Rosemary)	HAND SANITIZER SPRAY	Tubby Todd	2992a52a-21a9-18be-e063-6294a90a834d	2024-12-18	Warnings	Exact identifier application number: M003
CVS Decolorized Iodine	ALCOHOL	CVS Pharmacy	d9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd	2024-12-18	Warnings	Exact identifier application number: M003
De La Cruz Decolorized Iodine	ETHYL ALCOHOL	DLC Laboratories, Inc.	5d8f6aaa-0b87-1166-e053-2991aa0a297f	2024-12-18	Warnings	Exact identifier application number: M003
Humco Povidone Iodine	POVIDONE IODINE 10%	Humco Holding Group, Inc.	1e078022-f32c-48bd-8add-f83aebcc5812	2024-12-18	Warnings	Exact identifier application number: M003
Univ of Vermont Medical Center Amenity	BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	7841cfa9-e94e-4c3d-b5fb-676924017845	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital Mothers Vaginal	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	7f1a85fd-086b-4fc7-abac-863dd3ea505a	2024-12-17	Warnings	Exact identifier application number: M003
Mary Kay Satin Hands Shea Hand Sanitizer	ALCOHOL	Mary Kay Inc.	b6c2b979-2940-1569-e053-2995a90a532c	2024-12-17	Warnings	Exact identifier application number: M003
Foster and Thrive Decolorized Iodine	ALCOHOL LIQUID	Strategic Sourcing Services, LLC	2981529a-2bd0-3e9e-e063-6294a90a7236	2024-12-17	Warnings	Exact identifier application number: M003
Foster and Thrive 2% Mild Iodine Tincture	IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID	Strategic Sourcing Services, LLC	2981cb97-17de-ebda-e063-6394a90ad281	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital H.E.A.R.T. Strings Tote	ALCOHOL AND SODIUM MONOFLUOROPHOSPATE	ASP Global, LLc	f8369a27-1995-4fdd-a282-35c344c11d83	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital Amenity Kit	ALCOHOL AND SODIUM MONOFLUOROPHOSPATE	ASP Global, LLc	877ce875-c5b0-4d9b-8f00-682914e3bc0e	2024-12-17	Warnings	Exact identifier application number: M003
Wellstar Amenity	BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	ced9dd96-7922-43d7-906f-32afaad733ec	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital C-Section Mothers	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	9df6d0e9-631c-4619-9d96-d2c5a32a590e	2024-12-17	Warnings	Exact identifier application number: M003
Memorial Sloan Kettering Cancer Center Amenity Kit	SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	cab0bef1-f486-4eac-a61b-6030467d8650	2024-12-17	Warnings	Exact identifier application number: M003
Sarasota Memorial Amenity	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	f5dda019-fcfd-4e99-89cc-e79e76b402e7	2024-12-17	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
312563	povidone-iodine 10 % Topical Ointment	PSN	f80ccd8a-9b9b-bbf9-e053-6394a90ac827	2
312563	povidone-iodine 0.1 MG/MG Topical Ointment	SCD	f80ccd8a-9b9b-bbf9-e053-6394a90ac827	2
312563	povidone-iodine 10 % (equal to 1 % available iodine) Topical Ointment	SY	f80ccd8a-9b9b-bbf9-e053-6394a90ac827	2
312563	povidone-iodine 10 % Topical Ointment	SY	f80ccd8a-9b9b-bbf9-e053-6394a90ac827	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69396-112-20	69396011220	1 TUBE in 1 BOX (69396-112-20) / 28.3 g in 1 TUBE	1 tube	2022-12-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Globe Povidone Iodine USP 10%	Trifecta Pharmaceuticals USA LLC \| Trifecta Pharmaceuticals USA	2024-12-20	HUMAN OTC DRUG LABEL	2