Orajel 4X Medicated PM For Toothache and Gum, Cream

Manufacturer
Church & Dwight Co., Inc.
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:28:26

Label at a glance#

ProductOrajel 4X Medicated PM For Toothache and Gum
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE, ZINC CHLORIDE, MENTHOL, UNSPECIFIED FORM
Label structure12 sections

Indications and uses

for the temporary relief of pain due to minor irritation or injury of the mouth and gums first aid to help prevent infection in minor oral irritation

Dosage and administration

Adults and children 2 years of age and older 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#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Purpose

OTC - PURPOSE SECTION

Oral antiseptic, 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
  • first aid to help prevent infection in minor oral irritation

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 doctor if

OTC - STOP USE SECTION

  • symptoms do not improve in 7 days
  • 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 older

  • 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

Other information

OTHER SAFETY INFORMATION

  • do not use if Tamper-Evident Tab is open before first use
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, chamomile, flavor, PEG-8, PEG-75, PEG/PPG 116/66 copolymer, poloxamer 407, sodium saccharin, sorbic acid, titanium dioxide, 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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 ORAL PAIN RELIEVER FOR TOOTHACHES

Ready-Open Tube Tip

Orajel

4X MEDICATED FOR TOOTHACHE AND GUM

NIGHTTIME FORMULA WITH CHAMOMILE

INSTANT PAIN RELIEF CREAM

Clinical Strength Pain Relief

Proven to Kill Harmful Bacteria

Helps Prevent Infection

Cooling Relief for Gum Irritation

ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT

NET WT

0.25 OZ (7.0 g)

OJFC-31854-11.jpgOJFC-31854-11.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamPSN9
2370903benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral CreamSCD9
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamSY9

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
10237-789-25Orajel 4X Medicated PM For Toothache and Gum1 in 1 CARTONCREAM19
10237-789-25Orajel 4X Medicated PM For Toothache and Gum7 g in 1 TUBECREAM79

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-78910237-789-25

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 4X Medicated PM For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999cff2b-c23e-5abe-e053-2a95a90a75692025-12-12WarningsExact identifier
ndc (package): 10237-789-25
ndc (product): 10237-789
ndc11 (package): 10237078925
spl id: 45c30015-1521-2ab6-e063-6294a90ac193
spl set id: 999cff2b-c23e-5abe-e053-2a95a90a7569

Reported adverse events (FAERS/openFDA)#

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