OTC - ACTIVE INGREDIENT SECTION
Benzocaine 20%
Benzocaine 20%
Oral anesthetic
temporarily relieves pain associated with mouth and gum irritations
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
Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age
Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
to open tube, cut tip of tube on score mark * adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist/doctor * children under 12 years of age: adult supervision should be given in the use of this product * children under 2 years of age: do not use * for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
store at 20-25C (68-77F). Do not refrigerate.
blue 1, carbomer, flavor, glycerin, polyethylene glycol, propylene glycol, red 40, sodium saccharin, sorbic acid, water, yellow 10
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0316-69 | NBE Anbesol | 1 in 1 CARTON | GEL | 1 | 6 | |
| 0363-0316-69 | NBE Anbesol | 9 g in 1 TUBE | GEL | 9 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-0316 | 0363-0316-69 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| SORBIC ACID | X045WJ989B | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| CARBOXYPOLYMETHYLENE | 0A5MM307FC | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
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 |
|---|---|---|---|---|---|---|
| NBE Anbesol | BENZOCAINE | Walgreens | dd2a3125-32f8-5fff-e053-2995a90ac720 | 2025-11-21 | Warnings | 0363-0316-69 0363-0316 00363031669 441e7c47-f347-a262-e063-6394a90ae697 dd2a3125-32f8-5fff-e053-2995a90ac720 |
Adverse event summaries are temporarily unavailable. Other product information remains available.