do not exceed recommended dosage adults and children 2 years of age and older: 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
store at 15-30 °C (59-86 °F)
Benzocaine 20%
Oral Anesthetic
Usesfor the temporary relief of occasional minor irritation and pain associated with sore mouth and throat
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 if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Sore throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) Immediately
adults and children 2 years of age and older: 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
cherry flavor, polyethylene glycol, sucralose
(855) 879-4368
EverPharm
NDC 84415-044-01
Benzocaine 20% Spray
Unit Dose Non-Aerosol Spray
20% Benzocaine Oral Anesthetic
25 Unit Dose Non-Aerosol Sprays
0.017 fl.oz. (0.5 mL)
EverPharm
NDC 84415-044-01
Benzocaine 20% Spray
Unit Dose Non-Aerosol Spray
20% Benzocaine Oral Anesthetic
1 Unit Dose Non-Aerosol Spray
0.017 fl.oz. (0.5 mL)
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84415-044-01 | Benzocaine | 1 in 1 POUCH | SPRAY | 1 | 1 | |
| 84415-044-01 | Benzocaine | 25 in 1 PACKAGE | SPRAY | 25 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 84415-044-01 | EA - Each | 84415-044 | fe963d92-91de-4a01-8f84-dbc954d24cb7 | 1 | 2025-05-14 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 84415-044 | 84415-044-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| CHERRY | BUC5I9595W | 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 |
|---|---|---|---|---|---|---|
| Benzocaine | TOPICAL ANESTHETIC | Everpharm LLC | 2bc57111-0f15-b237-e063-6294a90a4471 | 2025-01-15 | Warnings | 84415-044-01 84415-044 84415004401 2bc582da-83f3-1644-e063-6294a90a8968 2bc57111-0f15-b237-e063-6294a90a4471 |
Adverse event summaries are temporarily unavailable. Other product information remains available.