FDA.reportPublic FDA data

Hydrogen Peroxide

Manufacturer
United Natural Foods, Inc. dba UNFI | Nice-Pak Products, LLC
Effective date
2026-02-17
Label type
HUMAN OTC DRUG LABEL
Version
20
Source
full-release
Hydrated at
2026-06-01 01:46:10

Label at a glance#

ProductHydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure13 sections

Indications and uses

first aid to help prevent the risk of infection in minor cuts, scrapes and burns aids in the removal of phlegm, mucous, or other secretions associated with occasional sore mouth

Dosage and administration

First aid antiseptic: clean the affected area apply a small amount of product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandaged, let dry first Oral Debriding agent:  adults and children 2 years of age and over: mix with equal amount of water swish around in the mouth over the affected area for at least 1 minute and then spit out use up to 4 times daily after meals and at bed...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

 Hydrogen peroxide (stabilized) 3%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Oral debriding agent

Uses

INDICATIONS & USAGE SECTION

  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • aids in the removal of phlegm, mucous, or other secretions associated with occasional sore mouth

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or apply over large areas of the body
  • longer than 1 week

Askd a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • the condition persists or gets worse
  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

First aid antiseptic:

  • clean the affected area
  • apply a small amount of product on the affected area 1 to 3 times a day
  • may be covered with a sterile bandage
  • if bandaged, let dry first


Oral Debriding agent: adults and children 2 years of age and over:

  • mix with equal amount of water
  • swish around in the mouth over the 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 doctor

Other information

GENERAL PRECAUTIONS SECTION

keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

ADVERSE REACTION

ADVERSE REACTIONS SECTION

Distributed by UNFI, Providence, RI 02908 USA

855-423-2630

Pat. D675, 101

Principal Panel Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41163-871-43

EQUALINE ®

3% USP

hydrogen peroxide

topical solution

  • first aid antiseptic
  • oral debriding agent
  • for treatment of minor cuts & abrasions
  • for use as a gargle

Do not use if printed seal under cap is broken or missing

16 FL OZ (1 PT) 473 mL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN20
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD20
91349hydrogen peroxide 3 % Topical SolutionSY20

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-871-43Hydrogen Peroxide473 mL in 1 BOTTLE, PLASTICSOLUTION47320
41163-871-45Hydrogen Peroxide946 mL in 1 BOTTLE, PLASTICSOLUTION94620

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-871-34ML - Milliliter41163-871c18a2f14-b700-413f-9229-f3581fc7f02c12013-11-04
41163-871-43ML - Milliliter41163-871e7898d65-63b9-4386-bb53-12e3eac2584712013-11-04
41163-871-45ML - Milliliter41163-871a6e00f95-5bf0-4f57-8ab9-e135742624bc12016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROGEN PEROXIDEACTIVE INGREDIENTBBX060AN9V2
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9V2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41163-87141163-871-43, 41163-871-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB

Source Document#

Source XML · Source PDF

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen PeroxideHYDROGEN PEROXIDEUnited Natural Foods, Inc. dba UNFI8a44aa29-58d6-4971-b572-4579f03ed2272026-02-17Warnings, Adverse reactionsExact identifier
ndc (package): 41163-871-45
ndc (package): 41163-871-43
ndc (product): 41163-871
ndc11 (package): 41163087145
ndc11 (package): 41163087143
spl id: 4b09664f-b476-8d36-e063-6294a90a6426
spl set id: 8a44aa29-58d6-4971-b572-4579f03ed227

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.