FDA.reportPublic FDA data

Hydrogen Peroxide

Manufacturer
Perrigo Direct, Inc | Nice-Pak Products, LLC
Effective date
2026-03-11
Label type
HUMAN OTC DRUG LABEL
Version
22
Source
full-release
Hydrated at
2026-06-01 01:49:30

Label at a glance#

ProductHydrogen Peroxide
Active ingredientHYDROGEN PEROXIDE
Label structure13 sections

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 (oral rinse): adults and children 2 years of age and over: mix with an 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 ...

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

Use

INDICATIONS & USAGE SECTION

  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • aids in the removal of phlegm, mucus, 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or pucture 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 (oral rinse):adults and children 2 years of age and over:

  • mix with an 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 

SPL UNCLASSIFIED 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

Distrubuted by: Perrigo Direct, Inc

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

Pat. D675, 101

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50804-871-43

GoodSense ®

Hydrogen Peroxide

Topical Solution USP

  • First Aid Antiseptic
  • Oral Debriding Agent

100% SATISFACTION GUARANTEED

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 SolutionPSN22
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD22
91349hydrogen peroxide 3 % Topical SolutionSY22

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
50804-871-34Hydrogen Peroxide236 mL in 1 BOTTLE, PLASTICSOLUTION23622
50804-871-43Hydrogen Peroxide473 mL in 1 BOTTLE, PLASTICSOLUTION47322
50804-871-45Hydrogen Peroxide946 mL in 1 BOTTLE, PLASTICSOLUTION94622
50804-871-99Hydrogen Peroxide236 mL in 1 BOTTLE, SPRAYSOLUTION23622

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-871-34ML - Milliliter50804-871b4a8cf1d-5557-44e8-b7a8-1e8a9536f4f612017-06-15
50804-871-43ML - Milliliter50804-871ac08afab-93eb-4e0d-8bef-36430db41c0812017-04-05
50804-871-99ML - Milliliter50804-871a5189623-ddf9-4ae8-b8b0-c7dc2e5286c712024-02-14

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
50804-87150804-871-34, 50804-871-43, 50804-871-45, 50804-871-99

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
212026-02-19monthly-update2026-06-03 17:56:41

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 PEROXIDEPerrigo Direct, Inc2efcda54-b8b7-4266-89c0-7f686c7afdca2026-03-11Warnings, Adverse reactionsExact identifier
ndc (package): 50804-871-43
ndc (package): 50804-871-34
ndc (package): 50804-871-99
ndc (package): 50804-871-45
ndc (product): 50804-871
ndc11 (package): 50804087199
ndc11 (package): 50804087143
ndc11 (package): 50804087134
ndc11 (package): 50804087145
spl id: 4cc11230-15b0-238a-e063-6294a90a31a1
spl set id: 2efcda54-b8b7-4266-89c0-7f686c7afdca

Reported adverse events (FAERS/openFDA)#

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