Orajel 4X Medicated Toothache and Gum Gel

Manufacturer
Church & Dwight Co., Inc.
Effective date
2026-08-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-02 00:03:41

Label at a glance#

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

Dosage and administration

adults and children 3 years of age and over apply to affected area up to 4 times daily or as directed by a dentist or doctor children between 3 and 12 years of age should be supervised in the use of this product children under 3 years of age do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Belzalkonium chloride 0.02%

Benzocaine 20%

Menthol 0.76%

Zinc chloride 0.15%

Purpose

OTC - PURPOSE SECTION

Oral antiseptic, Oral pain reliever, Oral astringent

Use

INDICATIONS & USAGE SECTION

  • first aid to help prevent infection in minor oral irritation
  • 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 the 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 3 years of age

Stop use and ask a 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

If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 3 years of age and over

  • apply to affected area up to 4 times daily or as directed by a dentist or doctor

children between 3 and 12 years of age

  • should be supervised in the use of this product

children under 3 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, flavor, PEG-8, PEG-75, raspberry ketone, 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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 ORAL PAIN RELIEF BRAND FOR ADULTS

OUR MAXIMUM STRENGTH

Orajel

4X MEDICATED TOOTHACHE & GUM GEL

ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT

IMMEDIATE RELIEF OF SEVERE PAIN

Provides Long-Lasting Pain Relief*

Helps Prevent Infection & Kills Harmful Bacteria

Relieves Throbbing Pain

Delivers Targeted Pain Relief

NET WT

0.25 oz (7.0 g)

Orajel 4X GELOrajel 4X GEL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130310310325039GTIN-13: 0310310325039
EAN-13: 0310310325039
GTIN-12: 310310325039
UPC-A: 310310325039
GTIN storage (14 digits): 00310310325039
Orajel 4X GEL.jpg
QR code linkQR Codel.ead.me/bcJ21GOrajel 4X GEL.jpg

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-88710237-887-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
ndc (package): 10237-887-25
ndc (product): 10237-887
ndc11 (package): 10237088725
spl id: 5a1bd621-3a4b-2fa1-e063-6294a90a5b7c
spl set id: 5a1b4133-0eac-2f8f-e063-6394a90af8f6

Reported adverse events (FAERS/openFDA)#

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