Indications and uses
For the temporary relief of canker sores minor injury of the mouth and gums minor irritation of the mouth and gums caused by dentures or orthodontic appliances
DoloDent (WP)
- Manufacturer
- Pharmadel LLC
- Effective date
- 2026-05-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:58:48
Label at a glance#
ProductDolodent Maximum Strength
Active ingredientBENZOCAINE
Label structure9 sections
Dosage and administration
adults and children 2 years of age and older: apply product to a cotton swab or finger to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of the product children under 2 years of age: do not use
Contacts and useful links#
Websitewww.pharmadel.com
www.pharmadel.com
www.pharmadel.comLabel contents#
Full prescribing information#
Active ingredient and Purpose
.
OTC - PURPOSE SECTION
| Active ingredient | Purpose |
| Benzocaine 20%...................... | Oral pain reliever |
Uses
For the temporary relief of
- 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 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.
Flammable. Keep away from fire or flame. Avoid smoking during application.
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
Stop use and ask your doctor or dentist if
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
Keep out of reach of children.
If more than used for pain is accidentally swallowed or an allergic reaction occurs, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older:
- apply product to a cotton swab or finger to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor
- children under 12 years of age should be supervised in the use of the product
- children under 2 years of age: do not use
Other information
- do not use if clear seal over cap is torn, broken, or missing
- store between 68-77°F (20-25°C)
Inactive ingredients
alcohol, clove oil, glycerin, polyethylene glycol, propylene glycol, sodium saccharin, sodium methylparaben
Questions or comments?
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Dist. by/ por:
Principal Display Panel
DailyMed RxNorm Mappings#
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 |
|---|---|---|---|---|---|---|
| 55758-505-01 | DolodentMaximum Strength | 1 in 1 CARTON | LIQUID | 1 | 4 | |
| 55758-505-01 | DolodentMaximum Strength | 15 mL in 1 BOTTLE, SPRAY | LIQUID | 15 | 4 |
Products#
Every source-derived product name is available through these pages.
- Dolodent Maximum Strength
- Benzocaine
- ALCOHOL
- CLOVE OIL
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SODIUM SACCHARIN
- SODIUM METHYLPARABEN
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-505 | 55758-505-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| CLOVE OIL | 578389D6D0 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| SODIUM SACCHARIN | SB8ZUX40TY | IACT |
| SODIUM METHYLPARABEN | CR6K9C2NHK | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2025-12-04 | monthly-update | 2026-06-03 17:45:22 |
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 |
|---|---|---|---|---|---|---|
| Dolodent Maximum Strength | BENZOCAINE | Pharmadel LLC | 351ecc2b-cc1a-2bbf-e063-6394a90a5c14 | 2026-05-26 | Warnings | 55758-505-01 55758-505 55758050501 52bc0c9b-e399-5c55-e063-6294a90aa2f2 351ecc2b-cc1a-2bbf-e063-6394a90a5c14 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.