OTC - ACTIVE INGREDIENT SECTION
Benzocaine 20%
Benzocaine 20%
Pain reliever
For the temporary relief of pain due to minor irritation of the mouth and gums caused by dentures or orthodontic appliances or injury to mouth and gums.
Adults and children12 years and over:
children under 12 years:consult a dentist or doctor
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 to the blood. This can occur even if you have used this product before. Stop use and seek immedicate medical attention if you or a child in your care develops:
Alllergy alert:Do not use if you have a history of allergy to local anetsthetics such as procaine, butacaine, benzocaine, or other "caine: anesthetics. Localized allergic reactions may occur after prolonged or repeated use.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
cellulose gum, D&C red no.30 lake, eugneol, FD&C blue no. 1 lake, oxyquinoline sulfate, petrolatum
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 723562 | benzocaine 20 % Topical Cream | PSN | 8 |
| 1112942 | Benzodent 20 % Topical Cream | PSN | 8 |
| 1112942 | benzocaine 200 MG/ML Topical Cream [Benzodent] | SBD | 8 |
| 723562 | benzocaine 200 MG/ML Topical Cream | SCD | 8 |
| 723562 | benzocaine 20 % Topical Cream | SY | 8 |
| 1112942 | Benzodent 20 % Oromucosal Topical Cream | SY | 8 |
| 1112942 | Benzodent 200 MG/ML Topical Cream | SY | 8 |
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71687-1053-1 | 2025-04-14 | C162847 | 48780-1 | 2cef2736-a33e-d83d-e063-dadaa90ab31f | Benzodent |
| 71687-1053-2 | 2025-04-14 | C162847 | 48780-1 | 2cef2736-a33e-d83d-e063-dadaa90ab31f | Benzodent |
| 71687-1053-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a33e-d83d-e063-dadaa90ab31f | Benzodent |
| 71687-1053-2 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a33e-d83d-e063-dadaa90ab31f | Benzodent |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71687-1053-1 | Benzodent | 7 g in 1 TUBE | CREAM | 7 | 8 | |
| 71687-1053-1 | Benzodent | 1 in 1 CARTON | CREAM | 1 | 8 | |
| 71687-1053-2 | Benzodent | 28 g in 1 TUBE | CREAM | 28 | 8 | |
| 71687-1053-2 | Benzodent | 1 in 1 CARTON | CREAM | 1 | 8 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71687-1053 | 71687-1053-1, 71687-1053-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| D&C RED NO. 30 | 2S42T2808B | IACT |
| EUGENOL | 3T8H1794QW | IACT |
| ALUMINUM OXIDE | LMI26O6933 | IACT |
| OXYQUINOLINE SULFATE | 61VUG75Y3P | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| BENZOCAINE | U3RSY48JW5 | 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 |
|---|---|---|---|---|---|---|
| Benzodent | BENZOCAINE | Focus Consumer Healthcare, LLC | 5fdcb871-d387-6352-e053-2991aa0a09da | 2026-04-20 | Warnings | 71687-1053-2 71687-1053-1 71687-1053 71687105301 71687105302 4fe8bad9-af0f-ad56-e063-6394a90a6e12 5fdcb871-d387-6352-e053-2991aa0a09da |
Adverse event summaries are temporarily unavailable. Other product information remains available.