Indications and uses
for the temporary relief of pain due to minor irritation or injury of the mouth and gums first aid to help prevent infection in minor oral irritation
for the temporary relief of pain due to minor irritation or injury of the mouth and gums first aid to help prevent infection in minor oral irritation
Adults and children 2 years of age and older Apply to affected area up to 4 times daily or as directed by a dentist or doctor Children between 2 and 12 years of age Ask a doctor before use. Should be supervised in the use of this product Children under 2 years of age Do not use
Benzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.26%
Zinc chloride 0.15%
Oral antiseptic, Oral pain reliever, Oral astringent
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 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, 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
In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away
Adults and children 2 years of age and older
Children between 2 and 12 years of age
Children under 2 years of age
ammonium glycyrrhizate, chamomile, flavor, PEG-8, PEG-75, PEG/PPG 116/66 copolymer, poloxamer 407, sodium saccharin, sorbic acid, titanium dioxide, water
call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at
www.orajel.com
1 ORAL PAIN RELIEVER FOR TOOTHACHES
Ready-Open Tube Tip
Orajel
4X MEDICATED FOR TOOTHACHE AND GUM
NIGHTTIME FORMULA WITH CHAMOMILE
INSTANT PAIN RELIEF CREAM
Clinical Strength Pain Relief
Proven to Kill Harmful Bacteria
Helps Prevent Infection
Cooling Relief for Gum Irritation
ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT
NET WT
0.25 OZ (7.0 g)
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2370903 | benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Cream | PSN | 9 |
| 2370903 | benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral Cream | SCD | 9 |
| 2370903 | benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Cream | SY | 9 |
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-789-25 | Orajel 4X Medicated PM For Toothache and Gum | 1 in 1 CARTON | CREAM | 1 | 9 | |
| 10237-789-25 | Orajel 4X Medicated PM For Toothache and Gum | 7 g in 1 TUBE | CREAM | 7 | 9 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10237-789 | 10237-789-25 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PEG-75 LANOLIN | 09179OX7TB | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| CHAMOMILE | FGL3685T2X | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| PEG/PPG-116/66 COPOLYMER | JP0CK963E0 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| ZINC CHLORIDE | 86Q357L16B | ACTIM |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
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 4X Medicated PM For Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999cff2b-c23e-5abe-e053-2a95a90a7569 | 2025-12-12 | Warnings | 10237-789-25 10237-789 10237078925 45c30015-1521-2ab6-e063-6294a90ac193 999cff2b-c23e-5abe-e053-2a95a90a7569 |
Adverse event summaries are temporarily unavailable. Other product information remains available.