Active Ingredients And Purpose
Active ingredient
Benzocaine 20%
Purpose
Oral pain reliever
Anbesol
- Manufacturer
- Foundation Consumer Brands
- Effective date
- 2025-02-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:55:37
Key Label Information#
Uses
Uses
temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures dentures
Warnings
Warnings
Directions And Dosage
Directions
to open tube, cut tip of the tube on score mark with scissors adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist 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 thin layer to the affected area do not reinsert dental work until irritation/pain is relieved rinse mouth well before reinserting
Other Label Information
Other information
store at 20-25°C (68-77°F) do not refrigerate
Inactive ingredients
benzyl alcohol, carbomer 934P, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin
Questions or comments?
Call 1-888-594-0673 weekdays 9 AM to 5 PM EST
PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack
MAXIMUM STRENGTH 20% Benzocaine Anbesol ® Oral Pain Reliever/Benzocaine 20% Instant Oral Pain Relief ADA Accepted American Dental Association Toothaches Canker Sores Aligner Pain Gum Pain GEL NET WT 0.33 OZ (9 g)
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1052633 | Anbesol Maximum Strength 20 % Oral Gel | PSN | 4 |
| 238910 | benzocaine 20 % Oral Gel | PSN | 4 |
| 1052633 | benzocaine 0.2 MG/MG Oral Gel [Anbesol] | SBD | 4 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | 4 |
| 1052633 | Anbesol 0.2 MG/MG Oral Gel | SY | 4 |
| 1052633 | Anbesol Maximum Strength 20 % Mucous Membrane Gel | SY | 4 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80070-220-33 | AnbesolMaximum Strength | 9 g in 1 TUBE | GEL | 9 | 4 | |
| 80070-220-33 | AnbesolMaximum Strength | 1 in 1 BLISTER PACK | GEL | 1 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
- Anbesol Maximum Strength
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80070-220 | 80070-220-33 |
Ingredients#
Complete SPL Sections#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Benzocaine 20%
Purpose
Oral pain reliever
Uses
temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures dentures
Warnings
Directions
to open tube, cut tip of the tube on score mark with scissors adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist 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 thin layer to the affected area do not reinsert dental work until irritation/pain is relieved rinse mouth well before reinserting
Other information
store at 20-25°C (68-77°F) do not refrigerate
Inactive ingredients
benzyl alcohol, carbomer 934P, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin
Questions or comments?
Call 1-888-594-0673 weekdays 9 AM to 5 PM EST
SPL UNCLASSIFIED SECTION
Distributed by: Foundation Consumer Brands, LLC Pittsburgh, PA 15212
PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack
MAXIMUM STRENGTH 20% Benzocaine Anbesol ® Oral Pain Reliever/Benzocaine 20% Instant Oral Pain Relief ADA Accepted American Dental Association Toothaches Canker Sores Aligner Pain Gum Pain GEL NET WT 0.33 OZ (9 g)