FDA.reportPublic FDA data

Orajel Rescue Relief Pen

Manufacturer
Church & Dwight Co., Inc.
Effective date
2025-06-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:19

Label at a glance#

ProductOrajel Rescue Relief Pen
Active ingredientZINC CHLORIDE, MENTHOL, BENZOCAINE
Label structure9 sections

Indications and uses

• for the temporary relief of • pain due to minor irritation or injury of the mouth and gums • occasional sore mouth and sore throat

Dosage and administration

adults and children 2 years of age and older apply to the 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#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%
Menthol 0.26%

Zinc chloride 0.15%

PURPOSE

OTC - PURPOSE SECTION

Oral Pain Reliever / Oral Astringent

USES

INDICATIONS & USAGE SECTION

• for the temporary relief of
• pain due to minor irritation or injury of the mouth and gums
• occasional sore mouth and sore throat

WARNINGS

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

DO NOT USE

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 DENTIST OR DOCTOR IF

OTC - STOP USE SECTION

• sore throat is severe, persists for more than 2 days

• sore mouth symptoms do not improve in 7 days

• headache, nausea, vomiting, swelling, rash or fever develops

• irritation, pain or redness persists or worsens

KEEP OUT OF REACH OF CHILDREN

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 olderapply to the 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 package has been opened

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ammonium glycrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, 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

Orajel™

TOOTHACHE & GUM

IMMEDIATE RELIEF OF:

ORAL PAIN

BRACE/DENTURE IRRITATION

GUM DISCOMFORT

CANKER SORES

RESCUE RELIEF PEN

GENTLE. TARGETED. TOUCH-FREE.

PLUS COOLING RELIEF

50+ USES

ORAL PAIN RELIEVER / ASTRINGENT

NET WT 0.07 OZ (2.0 g)

Orajel PenOrajel Pen

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2362013benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral GelPSN2
2362013benzocaine 0.2 MG/MG / menthol 0.0026 MG/MG / zinc chloride 0.0015 MG/MG Oral GelSCD2
2362013benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral GelSY2

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
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
10237-731-07Orajel Rescue Relief Pen1 in 1 BLISTER PACKGEL12
10237-731-07Orajel Rescue Relief Pen2 g in 1 APPLICATORGEL22
10237-731-27Orajel Rescue Relief Pen1 in 1 BLISTER PACKGEL12
10237-731-27Orajel Rescue Relief Pen2 in 1 PACKAGEGEL22

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-73110237-731-07, 10237-731-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC CHLORIDE86Q357L16BACTIM
MENTHOLL7T10EIP3AACTIB
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
WATER059QF0KO0RIACT
BENZOCAINEU3RSY48JW5ACTIB
SORBIC ACIDX045WJ989BIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PEG-75G2M7P15E5PIACT
SODIUM SACCHARINSB8ZUX40TYIACT

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 Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
ndc (package): 10237-731-27
ndc (package): 10237-731-07
ndc (product): 10237-731
ndc11 (package): 10237073127
ndc11 (package): 10237073107
spl id: 38d791e8-33d3-22e4-e063-6394a90aff90
spl set id: 2d68eec5-ae8a-9cdf-e063-6294a90a9799

Reported adverse events (FAERS/openFDA)#

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