Orajel

Manufacturer
BioFilm | Church & Dwight Co., Inc.
Effective date
2020-01-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:43:44

Label at a glance#

ProductOrajel
Active ingredientMENTHOL, BENZOCAINE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 15 mg

Menthol 2.5 mg

OTC - PURPOSE SECTION

Benzocaine - Oral Pain Reliever

Menthol - Oral Pain Reliever

INDICATIONS & USAGE SECTION

Use for the temporary relief of pain due to minor irritation or injury of the mouth and gums

WARNINGS SECTION

Warnings

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 to 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 • fatique 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

Do not use • more than directed • for more than 7 days unless directed by a physician or healthcare provider • for teething • in children under 12 years of age

OTC - STOP USE SECTION

Stop use and ask a phyisican 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

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions • make sure hands are dry and free of moisture as strip may be sticky/tacky • tear open pouch and remove blue strip

Adults and children 12 years or age and over: Using either side of strip, immediately place directly onto the affected area keeping tongue and lips clear. Gently press for 5-10 seconds until strip adheres to the area. Strip will stay in place and dissolve slowly in mouth for up to 1 hour for duration of treatment. Use up to 4 times daily or as directed by a physician or healthcare provider.

Children under 12 years of age: Do not use

OTHER SAFETY INFORMATION

Other Information • do not use if pouch is torn or cut prior to opening • do not use continously • for best results, avoid drinking warm beverages or eating for at least one hour after applying the product

INACTIVE INGREDIENT SECTION

acid blue 9, glycerin, PEG-8, PEG-90, polycarbophil, potassium sorbate, pullulan, PVP, titanium dioxide, water.

OTC - QUESTIONS SECTION

Questions • call us at 800 952 5080 Monday through Friday 9am to 5pm or visit our website at www orajel com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 ORAL PAIN

Reliever Brand

For Toothache

NEW!

SLOW DISSOLVING STRIPS

For Lasting Relief

Orajel™

TOOTHACHE STRIPS

MEDICATED FOR TOOTHACHE & GUM

INSTANT & TARGETED PAIN RELIEF

• Long-Lasting Pain Relief

•Maximum level of Pain Relief with 15mg Benzocaine*

•Stays in place for Targeted Relief

•Soothes gums with Menthol

Cool Mint Taste

8 STRIPS

Individually Wrapped

Oral Pain Reliever

OJFC-9986-01.jpgOJFC-9986-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72337-776-012024-10-22C16284748780-1d6a99b39-a032-a426-e053-dadaa90af4c2Orajel Toothache Strips
72337-776-012022-01-28C16284748780-1d6a99b39-a032-a426-e053-dadaa90af4c2Orajel Toothache Strips

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
72337-77672337-776-01

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 · Source PDF

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
2518360f-4e83-b0e9-e063-6394a90ad77a71d7e8b7-a059-7843-e053-2a95a90affde2024-10-22WarningsExact identifier
spl set id: 71d7e8b7-a059-7843-e053-2a95a90affde

Reported adverse events (FAERS/openFDA)#

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