Povi-One

Product NDC: 57511-0611
11-digit product format: 575110611
Labeler code: 57511
Product ID: 57511-0611_3f1914a6-3095-23c3-e063-6294a90ac03a
Type: HUMAN OTC DRUG
Nonproprietary name: Povidone-Iodine 10% Topical
Dosage form: LIQUID
Route: TOPICAL
Labeler: Elevate Oral Care
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-03-01
Substance: POVIDONE-IODINE
Active strength: 1 mg/10mL
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: Povi-One
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE-IODINE	1 mg/10mL

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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f5252b4f-5e14-509e-e053-2995a90a6db8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
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
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57511-0611-1	Povi-One	6 mL in 1 BOX, UNIT-DOSE	LIQUID	6		6
57511-0611-2	Povi-One	8 mL in 1 BOTTLE, DISPENSING	LIQUID	8		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57511-0611	POVI-ONE (POVIDONE-IODINE 10% TOPICAL) LIQUID [ELEVATE ORAL CARE]	2	Current NDC, 1 package rows	20231031_f5252b4f-5e14-509e-e053-2995a90a6db8.zip
57511-0611	POVI-ONE (POVIDONE-IODINE 10% TOPICAL) LIQUID [ELEVATE ORAL CARE]	2	Current NDC, 1 package rows	20250507_27c29a33-d1cc-d72f-e063-6394a90a4d45.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 34 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier application number: M022
BIOTENE Fresh Mint Original	SODIUM FLUORIDE	Haleon US Holdings LLC	1101c17f-c848-4cd5-a7cd-679b59dbe1bf	2024-11-05	Warnings	Exact identifier application number: M022
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Cherry	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	a0e145c8-6b08-40be-ae4f-5678c4a78b1e	2024-10-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33b-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Mint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	be57ca56-834f-4170-a407-f193484d8b0a	2024-10-29	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	Warnings	Exact identifier application number: M022
Chloraspetic	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	2b1808b2-2574-4ab8-a762-5733251848ce	2024-10-25	Warnings	Exact identifier application number: M022
Chloraseptic Warming Sore Throat	PHENOL	Prestige Brands Holdings, Inc.	a197fab2-70ce-4a6c-9add-29d7368a75c5	2024-10-25	Warnings	Exact identifier application number: M022
Gly-Oxide	CARBAMIDE PEROXIDE	Medtech Products Inc.	086a0b82-e947-41c9-89e7-ba06483960c9	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	d500f423-b9f2-4d98-8f2a-8bab7c05737c	2024-10-25	Warnings	Exact identifier application number: M022

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	Sample	Exclude flag	Status
57511-0611-1	57511061101	6 mL in 1 BOX, UNIT-DOSE (57511-0611-1)	6 ml	2023-03-01	No	No	Current
57511-0611-2	57511061102	8 mL in 1 BOTTLE, DISPENSING (57511-0611-2)	8 ml	2024-12-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Povi-One - Elevate Oral Care	Elevate Oral Care	2025-09-19	HUMAN OTC DRUG LABEL	4
Povi-One	Elevate Oral Care	2025-09-18	HUMAN OTC DRUG LABEL	6