Indications and uses
Uses for the temporary relief of pain due to • canker sores • minor injury of the mouth and gums • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Orajel 2x Medicated for Toothache and Gum, Liquid
- Manufacturer
- Church & Dwight Co., Inc.
- Effective date
- 2026-06-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- weekly-update
- Hydrated at
- 2026-07-17 21:42:03
Label at a glance#
ProductOrajel Medicated for Toothache and Gum, Liquid
Active ingredientBENZOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure10 sections
Dosage and administration
• remove safety seal from bottle cap adults and children 2 years of age and over Apply product with applicator brush to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. children between 2 and 12 years of age should be supervised in the use of this product children under 2 years of age do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Orajel 2x Medicated Toothache and Mouth Sores
Active ingredients
Benzocaine 20%
Menthol 0.1%
Purpose
Oral pain reliever
Uses
Usesfor the temporary relief of pain due to • canker sores • minor injury of the mouth and gums • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
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 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 or 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
Flammable: keep away from fire or flame. Avoid smoking during application.
OTC - DO NOT USE SECTION
Do not use • more than directed • for more than 7 days unless directed by a dentist or doctor • for teething • in children under 2 years of age
OTC - STOP USE SECTION
Stop use and ask a doctor if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If more than is used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
•remove safety seal from bottle cap
| adults and children 2 years of age and over | Apply product with applicator brush to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. |
| children between 2 and 12 years of age | should be supervised in the use of this product |
| children under 2 years of age | do not use |
Other information
• do not use if safety seal on bottle cap is broken or missing prior to opening
Inactive ingredients
alcohol (54.5% by volume), flavor, PEG-8, red 40, sodium saccarin, water, yellow 5
Questions or comments?
Call us at 800 952 5080 M-F 9am-5pm ET or visit our website at www orajel.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
#1 ORAL PAIN
RELIEF BRAND
FOR TOOTHACHE AND MOUTH SORES
Orajel™
2x MEDICATED TOOTHACHE & MOUTH SORES
IMMEDIATE PAIN RELIEF
Relieves Throbbing Pain
Delivers Targeted Pain Relief
Provides Long-Lasting Pain Relief*
Soothes Irritated Gums
ORAL-PAIN
RELIEVER
NEW!
APPLICATOR
BRUSH
FAST-ACTING LIQUID
*Up to 2 Hours
0.45 FL OZ (13.3 mL)
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code |  l.ead.me/bcJ21G | Orajel 2x Medicated Toothache Carton 72033864 2026.jpg |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10237-796-45 | 2024-02-05 | C162847 | 48780-1 | f386c649-d38a-0266-e053-dadaa90a7c1a | Orajel Medicated for Toothache and Gum, Liquid |
| 10237-796-45 | 2024-02-05 | C162847 | 48780-1 | f386c649-d38a-0266-e053-dadaa90a7c1a | Orajel 2x Medicated for Toothache and Gum, Liquid |
| 10237-796-45 | 2023-01-30 | C162847 | 48780-1 | f386c649-d38a-0266-e053-dadaa90a7c1a | Orajel Medicated for Toothache and Gum, Liquid |
| 10237-796-45 | 2023-01-30 | C162847 | 48780-1 | f386c649-d38a-0266-e053-dadaa90a7c1a | Orajel 2x Medicated for Toothache and Gum, Liquid |
Products#
Every source-derived product name is available through these pages.
- Orajel Medicated for Toothache and Gum, Liquid
- Benzocaine and Menthol
- FD&C YELLOW NO. 5
- ALCOHOL
- SACCHARIN SODIUM
- FD&C RED NO. 40
- WATER
- BENZOCAINE
- MENTHOL, UNSPECIFIED FORM
- POLYETHYLENE GLYCOL, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-796 | 10237-796-45 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-12-11 | full-release | 2026-06-01 01:22:19 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Orajel Medicated for Toothache and Gum, Liquid | BENZOCAINE AND MENTHOL | Church & Dwight Co., Inc. | ac3d605d-241d-1a6f-e053-2a95a90ae391 | 2026-06-01 | Warnings | 10237-796-45 10237-796 10237079645 557be35d-65ca-291a-e063-6294a90aac6e ac3d605d-241d-1a6f-e053-2a95a90ae391 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.