FDA.reportPublic FDA data

Orajel Antiseptic Alcohol-Free Mouth Sore Rinse

Manufacturer
Church & Dwight Co., Inc. | Church & Dwight Canada Corp.
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:39:42

Label at a glance#

ProductOrajel Antiseptic Alcohol-Free Mouth Sore Rinse
Active ingredientMENTHOL, UNSPECIFIED FORM, HYDROGEN PEROXIDE
Label structure11 sections

Indications and uses

first aid to help reduce bacteria in minor oral wounds for temporary pain relief and use in cleansing minor wounds or minor gum inflammation resulting from: minor dental procedures orthodontic appliances dentures accidental injury canker sores other irritations of the mouth and gums Aids in the removal of: phlegm mucus other secretions associated with occasional sore mouth

Dosage and administration

Adults and children 2 years of age and older Swish one-half capful (2 tesapoons=10mL) around 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 healthcare provider 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 healthcare provider

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrogen peroxide 1.5%

Menthol 0.1%

Purpose

OTC - PURPOSE SECTION

Oral debriding agent/Oral antiseptic, Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

  • first aid to help reduce bacteria in minor oral wounds
  • for temporary pain relief and
  • use in cleansing minor wounds or minor gum inflammation resulting from:
    • minor dental procedures
    • orthodontic appliances
    • dentures
    • accidental injury
    • canker sores
    • other irritations of the mouth and gums

Aids in the removal of:

  • phlegm
  • mucus
  • other secretions associated with occasional sore mouth

Warnings

WARNINGS SECTION

Do not usethis product for more than 7 days unless directed by a dentist or healthcare provider

When using this product

  • do not swallow
  • do not exceed recommended dosage

Stop Use

OTC - STOP USE SECTION

Stop Use and see your physician promptly if

  • swelling, rash or fever develops
  • irritations, pain or redness persists or worsens
  • sore mouth symptoms do not improve in 7 days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older

  • Swish one-half capful (2 tesapoons=10mL) around 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 healthcare provider

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 healthcare provider

Other information

OTHER SAFETY INFORMATION

  • cap tightly
  • keep away from heat or direct sunlight
  • do not use if safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments call us at 1–800–952–5080 M–F 9am–5pm ET or visit our website at www.orajel.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 ORAL PAIN RELIEVER BRAND FOR ADULTS

With PAIN RELIEF!

Orajel

ALCOHOL FREE

FOR ALL MOUTH SORES

ANTISEPTIC RINSE

Canker Sores Cheek Bites Gum Irritation Irritation from Dentures or Braces

Promotes Healing

Kills Bacteria

Provides Pain Relief

SOOTHING MINT RINSE

16 FL OZ (473.2 mL)

ORAL DEBRIDING AGENT/ANTISEPTIC RINSE/PAIN RELIEVER

DA2011185_OJLBF-00003-03_72013523DA2011185_OJLBF-00003-03_72013523

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2584344hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical SolutionPSN6
2584344hydrogen peroxide 15 MG/ML / menthol 1 MG/ML Mucous Membrane Topical SolutionSCD6
2584344hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical SolutionSY6

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
10237-784-16Orajel Antiseptic Alcohol-Free Mouth Sore Rinse473.2 mL in 1 BOTTLELIQUID473.26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-784ORAJEL ANTISEPTIC ALCOHOL-FREE MOUTH SORE RINSE (HYDROGEN PEROXIDE, MENTHOL) LIQUID [CHURCH & DWIGHT CO., INC.]6Current NDC, Legacy NDC, 1 package rows20241129_99d47d6a-fa2e-d5ee-e053-2995a90aa11d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-78410237-784-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
METHYL SALICYLATELAV5U5022YIACT
PHOSPHORIC ACIDE4GA8884NNIACT
POLOXAMER 338F75JV2T505IACT
POLYSORBATE 207T1F30V5YHIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
HYDROGEN PEROXIDEBBX060AN9VACTIB

Source Document#

Source XML

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
Orajel Antiseptic Alcohol-Free Mouth Sore RinseHYDROGEN PEROXIDE, MENTHOLChurch & Dwight Co., Inc.99d47d6a-fa2e-d5ee-e053-2995a90aa11d2024-11-27WarningsExact identifier
ndc (package): 10237-784-16
ndc (product): 10237-784
ndc11 (package): 10237078416
spl id: 27ea6bc8-f26b-d947-e063-6394a90ae2f5
spl set id: 99d47d6a-fa2e-d5ee-e053-2995a90aa11d

Reported adverse events (FAERS/openFDA)#

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