Orajel

Manufacturer
Church & Dwight Co., Inc. | Biofilm
Effective date
2020-08-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:18:30

Label at a glance#

ProductOrajel Toothache Strips
Active ingredientBENZOCAINE, MENTHOL
Label structure10 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 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

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

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

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-99886-02OJFC-99886-02

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-77610237-776-01

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
acc6c6fd-3c3a-dce7-e053-2995a90ac6f7724c559b-2ca3-3241-e053-2a91aa0a4d092020-08-13WarningsExact identifier
spl id: acc6c6fd-3c3a-dce7-e053-2995a90ac6f7
spl set id: 724c559b-2ca3-3241-e053-2a91aa0a4d09

Reported adverse events (FAERS/openFDA)#

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