Medline Peroxi Fresh

Product NDC: 53329-086
11-digit product format: 533290086
Labeler code: 53329
Product ID: 53329-086_5a0ca2e8-8f8c-a4c5-e063-6294a90af4c0
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrogen Peroxide
Dosage form: MOUTHWASH
Route: DENTAL
Labeler: Medline Industries, LP
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-01-01
Substance: HYDROGEN PEROXIDE
Active strength: 15 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53329-086	53329-086-13	D	Discontinued by firm		2026-10-12
excluded package	package	53329-086	53329-086-66	D	Discontinued by firm		2026-10-12

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	53329-086-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	53329-086-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	53329-086-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	53329-086-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	53329-086-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	53329-086-66	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	53329-086-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	53329-086-66	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	53329-086-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	53329-086-66	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	53329-086-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	53329-086-66	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	53329-086-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	53329-086-66	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	53329-086-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	53329-086-66	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	53329-086-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	53329-086-66	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	53329-086-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	53329-086-66	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	53329-086-13	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	53329-086-66	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	53329-086-13	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	53329-086-66	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Medline Peroxi Fresh
Brand name suffix: Mouthwash
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROGEN PEROXIDE	15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BBX060AN9V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
358975	Internal RxNorm lookup
1038750	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
ec7a9240-6c66-4471-b8b6-776e08a14fbc	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-086-13	Medline Peroxi FreshMouthwash	59 mL in 1 BOTTLE	MOUTHWASH	59	11
53329-086-14	Medline Peroxi FreshMouthwash	59 mL in 1 BOTTLE	MOUTHWASH	59	11
53329-086-66	Medline Peroxi FreshMouthwash	10 mL in 1 PACKET	MOUTHWASH	10	11
53329-086-95	Medline Peroxi FreshMouthwash	7 mL in 1 PACKET	MOUTHWASH	7	11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydrogen Peroxide	ACTIVE INGREDIENT	BBX060AN9V	MEDLINE PEROXI FRESH MOUTHWASH (HYDROGEN PEROXIDE) MOUTHWASH [MEDLINE INDUSTRIES, INC.]	1
Hydrogen Peroxide	ACTIVE MOIETY	BBX060AN9V	MEDLINE PEROXI FRESH MOUTHWASH (HYDROGEN PEROXIDE) MOUTHWASH [MEDLINE INDUSTRIES, INC.]	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	MEDLINE PEROXI FRESH MOUTHWASH (HYDROGEN PEROXIDE) MOUTHWASH [MEDLINE INDUSTRIES, INC.]	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	MEDLINE PEROXI FRESH MOUTHWASH (HYDROGEN PEROXIDE) MOUTHWASH [MEDLINE INDUSTRIES, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	MEDLINE PEROXI FRESH MOUTHWASH (HYDROGEN PEROXIDE) MOUTHWASH [MEDLINE INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-086	MEDLINE PEROXI FRESH MOUTHWASH (HYDROGEN PEROXIDE) MOUTHWASH [MEDLINE INDUSTRIES, LP]	11	Current NDC, Legacy NDC, 4 package rows	20241127_ec7a9240-6c66-4471-b8b6-776e08a14fbc.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 10 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Pro-Health Breath Purify and Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d71ed31f-cc33-2fc3-e053-2995a90ad39b	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Clinical	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	0a295ee0-55c2-4f21-8f0a-70efc0e51694	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d721e2cb-8f67-3d07-e053-2995a90ae65a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Advantage	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	ddcd56fe-25d6-8195-e053-2a95a90a575a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Bacteria Guard	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c2dc1f31-625d-a032-e053-2995a90a730d	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro Health Gum plus Bacteria Guard	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c598a4ab-5981-0068-e053-2a95a90af4fa	2026-01-08	Warnings	Exact identifier application number: M022
Oral B Gum Detoxify Special Care Rinse	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c2dcdde4-5542-1f87-e053-2995a90a261c	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Intense Fresh Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	62991165-ec81-48a8-e053-2991aa0a54f3	2026-01-08	Warnings	Exact identifier application number: M022
Crest Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	72f1a02f-1d02-7e83-e053-2a91aa0a7947	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Intense Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	6287bc3e-8b05-45d3-e053-2991aa0aaa10	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Multi-Protection Refreshing Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	8867d791-7e93-4f39-aaaf-bfbee8296fd9	2026-01-08	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Cream	BENZOCAINE	HEB	a71c5259-cbcf-7566-e053-2995a90a2cb6	2026-01-08	Warnings	Exact identifier application number: M022
Topco Associates LLC Maximum Strength	FLUORIDE	Topco Associates LLC	387d264c-90cc-5e67-e063-6394a90a713d	2026-01-08	Warnings	Exact identifier application number: M022
TopCare Sensitive Extra Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	TOPCO Assoc. LLC	835f41cf-e920-7df7-e053-2a91aa0a4479	2026-01-08	Warnings	Exact identifier application number: M022
Scope Icy Blast	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	164ed151-01d3-021a-e063-6294a90a0e51	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Advanced Enamel Care	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	1660e7d7-5b8d-8aba-e063-6294a90a50d8	2026-01-08	Warnings	Exact identifier application number: M022
Crest Deep Cleanse Germ Treatment	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	2d6b15d4-7827-ec2f-e063-6294a90a82c8	2026-01-08	Warnings	Exact identifier application number: M022
Crest Scope Original	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	21eed451-9368-146c-e063-6294a90af62b	2026-01-08	Warnings	Exact identifier application number: M022
3x Medicated Mouth Sore Gel	BENZOCAINE	HEB	a71c5259-cbd1-7566-e053-2995a90a2cb6	2026-01-08	Warnings	Exact identifier application number: M022
HEB Extra Whitening	FLUORIDE	HEB	b76c3591-6383-4661-b3db-7a56b11202f7	2026-01-08	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BBX060AN9V	HYDROGEN PEROXIDE	7722-84-1	HYDROGEN PEROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
358975	hydrogen peroxide 1.5 % Mouthwash	PSN	ec7a9240-6c66-4471-b8b6-776e08a14fbc	11
1038750	PEROXI-FRESH 1.5 % Mouthwash	PSN	ec7a9240-6c66-4471-b8b6-776e08a14fbc	11
1038750	hydrogen peroxide 15 MG/ML Mouthwash [Peroxi-Fresh]	SBD	ec7a9240-6c66-4471-b8b6-776e08a14fbc	11
358975	hydrogen peroxide 15 MG/ML Mouthwash	SCD	ec7a9240-6c66-4471-b8b6-776e08a14fbc	11
358975	hydrogen peroxide 1.5 % Mouthwash	SY	ec7a9240-6c66-4471-b8b6-776e08a14fbc	11
1038750	Peroxi-Fresh 1.5 % Mouthwash	SY	ec7a9240-6c66-4471-b8b6-776e08a14fbc	11
1038750	Peroxi-Fresh 15 MG/ML Mouthwash	SY	ec7a9240-6c66-4471-b8b6-776e08a14fbc	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-086-13	53329008613	59 mL in 1 BOTTLE	59 ml					Historical
53329-086-14	53329008614	59 mL in 1 BOTTLE (53329-086-14)	59 ml	2017-03-08	0000-00-00	No	No	Current
53329-086-66	53329008666	10 mL in 1 PACKET (53329-086-66)	10 ml	2007-01-01	0000-00-00	No	No	Current
53329-086-95	53329008695	7 mL in 1 PACKET (53329-086-95)	7 ml	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
086 Medline Peroxi Fresh	Medline Industries, LP	2026-08-27	HUMAN OTC DRUG LABEL	12
IIMED Hydrogen Peroxide Oral Rinse	IIMED MEDICAL MEXICANA S DE RL DE CV \| Team Technologies	2023-10-06	HUMAN OTC DRUG LABEL	1