Orajel 3X Medicated For All Mouth Sores, Gel

Manufacturer
Church & Dwight Co., Inc.
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:28:27

Label at a glance#

ProductOrajel 3X Medicated For All Mouth Sores
Active ingredientBENZOCAINE, MENTHOL, ZINC CHLORIDE
Label structure12 sections

Dosage and administration

Adults and children 2 years of age and over Apply to affected area up to 4 times daily or as directed by a dentist or doctor Children between 2 and 12 years of age Ask a doctor before use. Should be supervised in the use of this product Children under 2 years of age Do not use

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Menthol 0.1%

Zinc Chloride 0.15%

OTC - PURPOSE SECTION

Oral pain reliever and Oral astringent

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums

WARNINGS SECTION

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

OTC - DO NOT USE SECTION

  • more than directed
  • for more than 7 days unless directed by a dentist or doctor
  • for teething
  • in children under 2 years of age

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and overApply to affected area up to 4 times daily or as directed by a dentist or doctor
Children between 2 and 12 years of ageAsk a doctor before use. Should be supervised in the use of this product
Children under 2 years of ageDo not use

Other information

OTHER SAFETY INFORMATION

do not use if Tamper-Evident Tab is open before first use

INACTIVE INGREDIENT SECTION

allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 ORAL PAIN

RELIEF BRAND

FOR ADULTS

EXTRA STRENGTH

Orajel™

3X MOUTH SORES

MEDICATED

IMMEDIATE PAIN RELIEF

ORAL PAIN

RELIEVER/

ASTRINGENT

Provides

Long-Lasting

Pain Relief*

Helps Protect Sores

from Irritation

Delivers Targeted

Pain Relief

GEL

NET WT

0.18 OZ (5.1 g)

Orajel 3x Gel - 31840.jpgOrajel 3x Gel - 31840.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2266762benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral GelPSN5
2266762benzocaine 0.2 MG/MG / menthol 0.001 MG/MG / zinc chloride 0.0015 MG/MG Oral GelSCD5
2266762benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral GelSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-783-12Orajel 3X Medicated For All Mouth Sores1 in 1 CARTONGEL15
10237-783-12Orajel 3X Medicated For All Mouth Sores3.5 g in 1 TUBEGEL3.55
10237-783-18Orajel 3X Medicated For All Mouth Sores1 in 1 CARTONGEL15
10237-783-18Orajel 3X Medicated For All Mouth Sores5.1 g in 1 TUBEGEL5.15
10237-783-42Orajel 3X Medicated For All Mouth Sores1 in 1 CARTONGEL15
10237-783-42Orajel 3X Medicated For All Mouth Sores11.9 g in 1 TUBEGEL11.95

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-78310237-783-18, 10237-783-42, 10237-783-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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 3X Medicated For All Mouth SoresBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99b589ac-9833-fb60-e053-2995a90a09352025-12-12WarningsExact identifier
ndc (package): 10237-783-12
ndc (package): 10237-783-42
ndc (package): 10237-783-18
ndc (product): 10237-783
ndc11 (package): 10237078318
ndc11 (package): 10237078312
ndc11 (package): 10237078342
spl id: 45c2f5a1-7e8a-1fbd-e063-6394a90ab88f
spl set id: 99b589ac-9833-fb60-e053-2995a90a0935

Reported adverse events (FAERS/openFDA)#

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