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		2026-10-15
excluded package	package	53329-086	53329-086-66	D	Discontinued by firm		2026-10-15

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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SENSODYNE Rapid Relief	STANNOUS FLUORIDE	Haleon US Holdings LLC	f9589e7c-c5ca-4465-8d37-47ad6c69249f	2024-03-06	Warnings	Exact identifier application number: M022
SENSODYNE Repair and Protect Extra Fresh	STANNOUS FLUORIDE	Haleon US Holdings LLC	34260c69-d829-46c0-b12a-5136ee073ba1	2024-03-06	Warnings	Exact identifier application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTH	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	76adbccb-0812-4407-a6fc-a57e6f144fbb	2024-03-05	Warnings	Exact identifier application number: M022
SENSODYNE Advanced Whitening	POTASSIUM NITRATE	Haleon US Holdings LLC	a06e2549-3c4e-4818-b53e-1dea6828219f	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Extra Whitening Cool Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	c977f2c4-e0f3-44d2-aa7a-845f0583af3e	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Natural white	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	911ac7e4-2b92-43d5-af0b-b5f741b088fb	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Nourish Healthy White	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	aca38560-2fd7-47be-9e93-2abc3214e856	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Nourish Gently Soothing	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	5403ab67-532c-4bdf-9b06-07b1866f37f1	2024-03-04	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Active Shield Fresh Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	e8684615-f544-4871-b935-0a0f93639d7d	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Fresh Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	3dfa6827-3aae-4f19-93f6-2ded2faf2ddd	2024-03-04	Warnings	Exact identifier application number: M022
Made by Dentists Sensitive and Whitening Fresh Mint	POTASSIUM NITRATE, SODIUM FLUORIDE	MADE BY DENTISTS INC	0d379c26-69ff-4666-9ad5-7618f0bd139f	2024-02-27	Warnings	Exact identifier application number: M022
Polident ProPartial	STANNOUS FLUORIDE	Haleon US Holdings LLC	557eeb32-64f4-41e8-ada4-91bd39ae2920	2024-02-07	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Daily Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	edffce4d-108b-4ffd-9adf-e12cb42ffddd	2024-01-24	Warnings	Exact identifier application number: M022
Peppermint Twist	FLUORIDE	Caldwell Health LLC	4b28cdd1-0dba-42f5-a9e8-06d9e75b2396	2024-01-17	Warnings	Exact identifier application number: M022
The Natural Dentist Groovy Grape	FLUORIDE	Caldwell Consumer Health LLC	087abbed-1f58-4b45-a76b-a950fa81c18c	2024-01-16	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	Pharma Nobis, LLC	e42fccc2-1b4f-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M022
Sunmark Benzoin Compound Tincture	BENZOIN RESIN	Strategic Sourcing Services LLC	0c96d810-83dc-47d3-9a75-63a79feaad0a	2023-12-19	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	Humco Holding Group, Inc.	b33b5896-673b-498c-8a58-76ece8552f7a	2023-12-15	Warnings	Exact identifier application number: M022
Povidone Iodine	POVIDONE IODINE ORAL RINSE 0.5%	Humco Holding Group, Inc.	b83dbdd1-ff63-caf8-e053-2a95a90a5764	2023-12-15	Warnings	Exact identifier application number: M022
Moon Whitening Gel Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0c556a29-a697-3a66-e063-6394a90abfee	2023-12-12	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