Medline Peroxi Fresh Mouthwash

HYDROGEN PEROXIDE DENTAL HUMAN OTC DRUG

Medline Peroxi Fresh Mouthwash is an FDA drug label for the active ingredient HYDROGEN PEROXIDE manufactured by Medline Industries, LP administered by DENTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260827.

Generic name
HYDROGEN PEROXIDE
Manufacturer
Medline Industries, LP
Product type
HUMAN OTC DRUG
Route
DENTAL
Dosage form
N/A
NDC
53329-086
Application
M022
Label effective
20260827

About this product

Medline Peroxi Fresh Mouthwash is an FDA-registered drug product whose active ingredient is HYDROGEN PEROXIDE. It is labelled by Medline Industries, LP taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 53329-086, application M022, label effective 20260827. It is one of 28 FDA drug label records sharing the active ingredient HYDROGEN PEROXIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing HYDROGEN PEROXIDE are most often described in connection with: removal phlegm, secretions associated, occasional sore. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Hydrogen Peroxide 1.5%

Indications & Usage

Use aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Dosage & Administration

Directions Adults and Children 2 Years of Age or Over: Swish around in mouth over affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor. Children Under 12 Years of Age: Should be supervised in the use of this product. Children Under 2 Years of Age: Consult a dentist or a doctor.

Warnings

Warnings Do not use this product for more than 7 days unless directed by a dentist or physician. When using this product do not swallow Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops Keep out of reach of children If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away.

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How products containing HYDROGEN PEROXIDE compare

FDA lists 28 drug label records with HYDROGEN PEROXIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Medical Chemical Corporation 2
— — P & L Development, LLC 2
— — Strategic Sourcing Services LLC 2
— — 4 Visions LLC 1
— — Aero Healthcare US LLC 1

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0035-2026 Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30. Medline Industries, LP Class II Ongoing 20251029
D-0674-2025 READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25 Medline Industries, LP Class III Ongoing 20251001
D-0604-2025 Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78. MEDLINE INDUSTRIES, LP - Northfield Class II Ongoing 20250903
D-0602-2025 ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60. MEDLINE INDUSTRIES, LP - Northfield Class II Ongoing 20250903
D-0601-2025 CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30 MEDLINE INDUSTRIES, LP - Northfield Class II Ongoing 20250903

Frequently asked questions

What is Medline Peroxi Fresh Mouthwash used for?
Use aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Who makes Medline Peroxi Fresh Mouthwash?
Medline Industries, LP is the labeler of record for Medline Peroxi Fresh Mouthwash. 28 FDA label records share the active ingredient HYDROGEN PEROXIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Medline Peroxi Fresh Mouthwash come in?
administered by dental. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Medline Peroxi Fresh Mouthwash prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing HYDROGEN PEROXIDE?
Yes. 28 FDA drug label records list HYDROGEN PEROXIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Medline Peroxi Fresh Mouthwash been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.