Orajel Instant Pain Relief
- Manufacturer
- Church Dwight Co., Inc.
- Effective date
- 2017-04-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:16:57
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Benzocaine 20%
Menthol 0.25%
Benzalkonium Chloride 0.1%
Purpose
Oral pain reliever
Oral Pain reliever
Antiseptic
Use
- for the temporary relief of pain due to toothaches
- to help protect against infection in minor oral irritation
Warnings
Allergy alert: do not use this product if you have a histoy 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 - ASK DOCTOR 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
DOSAGE & ADMINISTRATION SECTION
Directions - cut open tip of tube on score mark
- Adults and children 2 years of age and over - Apply a samll amount of product to the cavity and around gum surrounding the teeth. 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 physicaian or healthcare provider
Other information
- do not use if tube tip is cut prior to opening
- this preparation is inteded for use in cases of toothache, only as a temporary expedient until a physician can be consulted
- do not use continuously
- Orajel Severe Pain Formula will stay in place for extended duration of relief
- avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Inactive ingredients
cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin
Questions or comments?
call us at
1-800-952-5080 M-F 9am-5pm ET or visit our website at
www.orajel.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
#1
ORAL PAIN
Reliever for
Toothache
Now with 3X MORE
Active Ingredients vs. Store Brand
ORAJEL™
Instant Pain Relief
SEVERE
Toothache & Gum Relief Plus
Triple Medicated
20% Benzocaine to Relieve Oral Pain
Antiseptic to Help Prevent Infection
Menthol to Soothe
Oral Pain Reliever NET WT 0.33 OZ (9.4g)
Long-Lasting Cream
OJFC-32501-06
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10237-747-32 | 2024-11-27 | C162847 | 48780-1 | 9d75b9d0-da8c-f424-e053-dadaa90a57ce | Orajel SEVERE Toothache & Gum Relief Plus TRIPLE MEDICATED |
| 10237-747-32 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-da8c-f424-e053-dadaa90a57ce | Orajel SEVERE Toothache & Gum Relief Plus TRIPLE MEDICATED |
Products#
Every source-derived product name is available through these pages.
- Orajel Instant Pain Relief Severe
- Benzocaine 20%, Menthol, Benzalkonium Chloride
- CARBOXYMETHYLCELLULOSE SODIUM
- GELATIN
- SACCHARIN SODIUM
- METHYL SALICYLATE
- MINERAL OIL
- PECTIN
- PETROLATUM
- POLYETHYLENE GLYCOL 1000
- BENZOCAINE
- BENZALKONIUM CHLORIDE
- BENZALKONIUM
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10237-747 | 10237-747-32 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| GELATIN | 2G86QN327L | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PECTIN | 89NA02M4RX | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 27e73fcf-a59c-2f08-e063-6394a90a9870 | 4ce932f7-46fd-2caf-e054-00144ff88e88 | 2024-11-27 | Warnings | 4ce932f7-46fd-2caf-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
