Orajel Denture Pain Relief

Manufacturer
Church & Dwight Co., Inc.
Effective date
2019-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:06:48

Label at a glance#

ProductOrajel Denture Pain Relief
Active ingredientMENTHOL, BENZOCAINE
Label structure11 sections

Dosage and administration

cut open tube on score mark Adults and children 2 years of age and over: Apply a thin layer to the affected area. Do not reinsert dental work until irritation/pain is relieved. Rinse out well before reinserting. Use up to 4 times daily or as directed by a physician or healthcare provider. Children under 12 years of age: Should be supervised in the use of this product Children under 2 years of age: Ask a physician ...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Benzocaine 20%

Menthol 0.7%

OTC - PURPOSE SECTION

Benzalkonium Chloride - Oral antiseptic

Benzocaine - Oral pain reliever

Menthol - Oral pain reliever

INDICATIONS & USAGE SECTION

Use for the temporary relief of • pain due to minor irritation of the mouth and gums caused by dentures • occasional minor irritation, pain, sore mouth.

WARNINGS SECTION

Warnings

• 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

Do not use • more than directed • for more than 7 days unless directed by a physician or healthcare provider

OTC - STOP USE SECTION

Stop use and ask a physician if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs

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

cut open tube on score mark

Adults and children 2 years of age and over:

Apply a thin layer to the affected area. Do not reinsert dental work until irritation/pain is relieved. Rinse out well before reinserting. Use up to 4 times daily or as directed by a physician or healthcare provider.

Children under 12 years of age:

Should be supervised in the use of this product

Children under 2 years of age:

Ask a physician or healthcare provider

Other Information • do not sue if tube tip is cut prior to opening • this preparation is intended for use in cases of denture pain, only as a temporary expedent until a physician can be consulted • do not use continuously • Orajel Denture Pain Gel will stay in place for extended duration of relief

INACTIVE INGREDIENT SECTION

Inactive Ingredients blue 1, cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin, water

OTC - QUESTIONS SECTION

Questions or comments call us at 800 952 5080 Monday through Friday 9-5 or visit our website www orajel com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1

Oral Pain

Reliever Brand

For Adults

New Formula!

3x More

Active Ingredients*

Orajel

Instant Pain Relief

For Denture Pain

Soothes Gum Pain & Irritation

Triple Medicated

10% Benzocaine to Relieve Pain from Dentures

Astringent to Relieve Gum Irriation NEW

Menthol to Soothe Gums Irritated by Dentures

Refreshing Mint

Long-Lasting Gel

Oral Pain Reliever/Astringent NET WT 0.25 OZ (7.0g)

OJFC-38405-03OJFC-38405-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10237-765-252024-12-05C16284748780-1ba0f9c33-5c37-a910-e053-dadaa90a0b85Orajel Denture Pain
10237-765-252021-01-29C16284748780-1ba0f9c33-5c37-a910-e053-dadaa90a0b85Orajel Denture Pain

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
10237-76510237-765-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
287579ef-749e-f9b8-e063-6394a90a0a4243cb4a9f-974e-4243-e054-00144ff8d46c2024-12-04WarningsExact identifier
spl set id: 43cb4a9f-974e-4243-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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