Overview
Benzocaine is an ester local anesthetic that acts by preventing transmission of impulses along nerve fibers and at nerve endings. It is commonly used for local anesthesia in many over the counter products. Benzocaine was first used for local anesthesia in dentistry.
Indication
Benzocaine is indicated for local anesthesia in dentistry, minor trauma, and as preparation for infiltrative anesthesia. Benzocaine products are indicated for topical anesthesia in a wide variety of conditions including skin irritation, oral pain, and hemorrhoids.
Associated Conditions
- Acute Sore Throat Pain
- Dental Pain
- Gangrene Stomatitis
- Gingivitis
- Haemorrhoids
- Laryngitis
- Pharyngitis
- Premature Ejaculation
- Secondary Bacterial Infection caused by Tonsillectomy
- Secondary Bacterial Infection caused by Tooth Extractions
- Skin Irritation
- Sore Throat
- Stomatitis
- Sunburn
- Teething pain
- Tonsillitis
- Tooth Pain
- Vomiting
- Pruritic dermatosis
- Ulceration of the mouth
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/25 | Early Phase 1 | Completed | University of Lahore | ||
2024/11/15 | Not Applicable | Not yet recruiting | |||
2023/12/11 | Phase 4 | Completed | |||
2023/05/16 | Not Applicable | Recruiting | Aliaa Hamouda | ||
2022/10/03 | Not Applicable | Recruiting | Minia University | ||
2021/09/29 | Early Phase 1 | Completed | |||
2020/03/23 | Phase 1 | Completed | Dina Youssef Attia | ||
2018/12/31 | Phase 2 | Completed | Nourhan M.Aly | ||
2018/02/14 | Phase 3 | Completed | |||
2017/04/17 | Phase 3 | Completed | Lachlan Pharma Holdings |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Henry Schein Inc | 0404-9442 | DENTAL | 230 mg in 1 mL | 4/30/2015 | |
| Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 68400-504 | DENTAL | 2.4 g in 12 g | 11/19/2013 | |
| Henry Schein, Inc. | 0404-0741 | TOPICAL | 200 mg in 1 g | 6/25/2015 | |
| NDC, Inc. | 43128-026 | DENTAL | 220 mg in 1 g | 9/4/2018 | |
| Roman Health Ventures Inc. | 72484-433 | TOPICAL | 4 g in 100 mL | 2/12/2025 | |
| SmartHealth, Inc. (DBA SmartPractice) | 69521-031 | DENTAL | 220 mg in 1 g | 12/28/2017 | |
| Walgreens | 0363-5337 | TOPICAL | 20 g in 100 g | 6/10/2025 | |
| Pascal Company, Inc. | 10866-0088 | DENTAL | 221 mg in 1 g | 1/22/2020 | |
| Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 68400-506 | DENTAL | 2.4 g in 12 g | 11/19/2013 | |
| Dentsply LLC. Professional Division Trading as "Sultan Healthcare" | 0699-3100 | PERIODONTAL | 220 mg in 1 g | 2/7/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| HURRICAINE SPRAY 20% | SIN08158P | SPRAY | 20% | 5/9/1995 | |
| TOPICALE GEL 180 mg/g | SIN10762P | GEL | 180 mg/g | 2/19/1999 | |
| HURRICAINE GEL 20% | SIN07825P | GEL | 20% | 8/11/1994 | |
| FREEZ-EEZ TOPICAL ANESTHETIC GEL 20% w/w | SIN12391P | GEL | 20% w/w | 8/14/2003 | |
| HORF LOZENGES | SIN08535P | LOZENGE | 2 mg | 2/5/1996 | |
| DORITHRICIN THROAT LOZENGES | SIN04392P | LOZENGE | 1.5 mg | 5/3/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Salicylic Acid and Benzocaine Ointment | 国药准字H42022801 | 化学药品 | 软膏剂 | 5/19/2020 | |
| Salicylic Acid and Benzocaine Ointment | 国药准字H12021011 | 化学药品 | 软膏剂 | 4/23/2020 | |
| Benzocaine Buccal Tablets | 国药准字H20080386 | 化学药品 | 片剂 | 8/29/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CEPACOL PLUS WITH ANAESTHETIC original flavour lozenge blister pack | 10097 | Medicine | A | 7/8/1991 | |
| EARCLEAR EAR ACHE RELIEF ear drops bottle | 125789 | Medicine | A | 2/27/2006 | |
| TRIMPLEX appetite control lozenges | 39769 | Medicine | A | 4/27/1992 | |
| SOLARCAINE SPRAY benzocaine 10mg/g pressurised spray aerosol can | 18204 | Medicine | A | 10/8/1991 | |
| NYAL TOOTHACHE DROPS solution bottle | 13659 | Medicine | A | 9/10/1991 | |
| CODRAL ACTIRELIEF SORE THROAT LOZENGES benzocaine 8mg berry flavoured lozenges bottle | 375395 | Medicine | A | 9/28/2021 | |
| ORAL-EZE GEL benzocaine 30mg/g cetylpyridinium chloride 100 micrograms /g, glycerol 100mg/g, ethanol 374 mg/g gel tube | 39774 | Medicine | A | 4/27/1992 | |
| AURALGAN EAR DROPS | 10460 | Medicine | A | 7/4/1991 | |
| DURO-TUSS DRY COUGH PLUS SORE THROAT lozenge blister pack (lemon flavour) | 10102 | Medicine | A | 7/8/1991 | |
| CEPACAINE ORAL SOLUTION mouthwash bottle | 10096 | Medicine | A | 7/8/1991 |
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