Freskaro Povidone Iodine

Product NDC: 82645-325
11-digit product format: 826450325
Labeler code: 82645
Product ID: 82645-325_4f712266-5467-a9e2-e063-6294a90a7b1b
Type: HUMAN OTC DRUG
Nonproprietary name: Povidone Iodine 10%
Dosage form: LIQUID
Route: TOPICAL
Labeler: Pharma Nobis, LLC
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-04-14
Substance: POVIDONE-IODINE
Active strength: 100 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: Freskaro Povidone Iodine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE-IODINE	100 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
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
4f711d3b-5ed6-5dd4-e063-6294a90afeaa	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
82645-325-16	Freskaro Povidone Iodine	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		1
82645-325-98	Freskaro Povidone Iodine	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237		1

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 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Englewood Amenity	BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	7c9ce1bf-6aa2-4073-ad09-2ddf845102a2	2024-12-17	Warnings	Exact identifier application number: M003
Mentholatum Moisturizing Hand Sanitizer	BENZALKONIUM CHLORIDE	The Mentholatum Company	365c93bc-2299-4e69-ba3a-69414bfe78d7	2024-12-13	Warnings	Exact identifier application number: M003
Curaplex Alcohol Prep Pad	ISOPROPYL ALCOHOL	Sarnova, Inc.	da1a4baa-05eb-4a75-82bb-39c547daef64	2024-12-12	Warnings	Exact identifier application number: M003
Foaming Hand Sanitizer	ALCOHOL	Empack Spraytech Inc.	8bb072f2-9cd4-499d-9d7f-7166451b8f20	2024-12-12	Warnings	Exact identifier application number: M003
Extra Stength Hand Sanitizer Zytec Germ Buster	ALCOHOL 80%W/W	Empack Spraytech Inc.	da854195-3a50-4fae-a5ea-183bf524c973	2024-12-12	Warnings	Exact identifier application number: M003
Zytec Hand Sanitizer Wipes 80% w/w Alcohol	ALCOHOL	Empack Spraytech Inc.	ab86fd0c-40cd-0bb6-e053-2a95a90a76e2	2024-12-12	Warnings	Exact identifier application number: M003
Dermoplast Kids First Aid	BENZETHONIUM CHLORIDE AND BENZOCAINE	Advantice Health, LLC.	29a18018-5214-4080-ac40-e646319e95ce	2024-12-12	Warnings	Exact identifier application number: M003
New Skin Bandage	BENZETHONIUM CHLORIDE	Advantice Health, LLC.	5846f414-8329-4034-b99f-92721bdb3d14	2024-12-12	Warnings	Exact identifier application number: M003
CVS Hand Sanitizer	ALCOHOL	CVS	b5faeb31-67c7-2000-e053-2995a90a1409	2024-12-10	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
312564	povidone-iodine 10 % Topical Solution	PSN	4f711d3b-5ed6-5dd4-e063-6294a90afeaa	1
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	4f711d3b-5ed6-5dd4-e063-6294a90afeaa	1
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	4f711d3b-5ed6-5dd4-e063-6294a90afeaa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82645-325-16	82645032516	473 mL in 1 BOTTLE, PLASTIC (82645-325-16)	473 ml	2026-04-14	No	No	Current
82645-325-98	82645032598	237 mL in 1 BOTTLE, PLASTIC (82645-325-98)	237 ml	2026-04-14	No	No	Current