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 13 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
S.T.37	HEXYLRESORCINOL	NUMARK BRANDS, INC	7d7acca2-aa8a-5272-e813-faab039cc798	2025-12-15	Warnings	Exact identifier application number: M022
Esunix Oral Bacteriostatic Gel	CETYLPYRIDINIUM CHLORIDE	Xiling (Zhenjiang) Medical Technology Co., Ltd.	3f4ee467-8142-8cb7-e063-6394a90aa7f7	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 4X Medicated For Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999851ac-925c-7d1f-e053-2a95a90a240b	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 3X Medicated For Toothache and Gum	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	99a2b061-0875-59a4-e053-2995a90ab373	2025-12-12	Warnings	Exact identifier application number: M022
Orajel Antiseptic Rinse For All Mouth Sores	HYDROGEN PEROXIDE AND MENTHOL	Church & Dwight Co., Inc.	06188d36-0d60-6ae6-e054-00144ff8d46c	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 3X Medicated For All Mouth Sores	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	99b589ac-9833-fb60-e053-2995a90a0935	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 4X Medicated For Toothache and Gum, Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999aa7b9-bf9e-9285-e053-2a95a90a345b	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 4X Medicated PM For Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999cff2b-c23e-5abe-e053-2a95a90a7569	2025-12-12	Warnings	Exact identifier application number: M022
Benzoin Compound Tincture	BENZOIN RESIN	Humco Holding Group, Inc.	a893a232-2ea8-4e0d-8cbf-7f5040b3be2e	2025-12-11	Warnings	Exact identifier application number: M022
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	456d45e8-bf6d-31c4-e063-6394a90a5c00	2025-12-10	Warnings	Exact identifier application number: M022
Oral pain relief	BENZOCAINE	ALAINA HEALTHCARE PRIVATE LIMITED	d98c1b2f-fe75-4d52-b082-1abb7628c59e	2025-12-09	Warnings	Exact identifier application number: M022
HEB Sensitive Extra Whitening Twin	SODIUM FLUORIDE	HEB	41d5ae3e-51c1-263b-e063-6394a90a3312	2025-12-08	Warnings	Exact identifier application number: M022
CankerMelts	BENZOCAINE	Quest Products, LLC	070dae82-14c2-66d2-e063-6394a90ab259	2025-12-04	Warnings	Exact identifier application number: M022
Sore Throat ReadyInCase	PHENOL	P & L Development, LLC	2fb3d17e-8ca3-4edb-8b82-4b484f42616e	2025-12-03	Warnings	Exact identifier application number: M022
Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	44f2b66a-26ae-1044-e063-6394a90a9ab6	2025-12-02	Warnings	Exact identifier application number: M022
Sensodyne Fresh Clean	STANNOUS FLUORIDE	Haleon US Holdings LLC	2d433ac1-3ddf-a2f4-e063-6394a90a91f8	2025-12-01	Warnings	Exact identifier application number: M022
Walgreens Saline	NASAL	WALGREEN COMPANY	147e45c8-1e71-4c06-89f1-42e9f9683366	2025-12-01	Warnings	Exact identifier application number: M022
EELHOE Probiotic Bright White Fresh	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	425cec0e-aa74-5341-e063-6294a90ac86b	2025-11-27	Warnings	Exact identifier application number: M022
EELHOE 5 Days Tooth Powder	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	42f98b14-d1d5-4af8-e063-6294a90a8f67	2025-11-27	Warnings	Exact identifier application number: M022
JAYSUING Colour Corrector	GLYCERIN	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	425d9c23-a692-3c62-e063-6294a90a9404	2025-11-27	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