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 | 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 |
|---|---|---|---|---|---|
| Rexall | 55910-346 | ORAL | 20 g in 100 mL | 8/12/2025 | |
| 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 | |
| CVS | 69842-642 | ORAL | 20 g in 100 g | 8/12/2025 | |
| 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 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| THUNAS PILE SUP | thuna herbal remedies ltd. | 00457299 | Suppository - Rectal | 50 MG / SUP | 12/31/1945 |
| PULMOSIRUM PASTILLE | nutribon (1986) inc. | 01912461 | Lozenge - Oral | 5 MG / LOZ | 12/31/1994 |
| DETANE GEL 7.5% | del pharmaceuticals inc. | 01915207 | Gel - Topical | 7.5 % | 12/31/1992 |
| ANBESOL BABY GEL 7.5% | wyeth consumer healthcare inc. | 01931040 | Gel - Oral | 7.5 % | 12/31/1992 |
| DERMAPHY ONT | produits phyto inc. | 00420212 | Ointment - Topical | 1 % | 12/31/1977 |
| ZILACTIN TOOTHACHE SWAB | zila pharmaceuticals inc. | 02243846 | Swab - Topical | 20 % | 1/4/2002 |
| POMMADE MIDY | welcker-lyster ltd., division of technilab inc. | 00292591 | Ointment - Rectal | 1 G / 100 G | 12/31/1948 |
| OXIPOR LOTION | whitehall-robins inc. | 01931121 | Lotion - Topical | 2.0 % | 12/31/1993 |
| ORAJEL EXTRA STRENGTH | commerce pharmaceutics inc. | 00523798 | Gel - Dental | 200 MG / G | 12/31/1981 |
| RECTOGEL HC | laboratoire riva inc. | 00662461 | Ointment - Rectal | 10 % | 5/26/1998 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ANESTEFARIN 5 mg/5 mg COMPRIMIDOS PARA CHUPAR | Farline Comercializadora De Productos Farmaceuticos S.A. | 68745 | COMPRIMIDO PARA CHUPAR | Sin Receta | Commercialized |
| NORMOBUCAL 200 MG/ML SOLUCION PARA PULVERIZACION BUCAL | Laboratorios Normon S.A. | 83169 | SOLUCIÓN PARA PULVERIZACIÓN BUCAL | Sin Receta | Commercialized |
| ANTIHEMORROIDAL CINFA POMADA RECTAL | Laboratorios Cinfa S.A. | 48992 | POMADA RECTAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| HIBITANE 5MG/5MG COMPRIMIDOS PARA CHUPAR SABOR ANIS | Ionfarma S.L. | 76771 | COMPRIMIDO PARA CHUPAR | Sin Receta | Not Commercialized |
| GARYDOL FORTE 5 MG/5 MG COMPRIMIDOS PARA CHUPAR | Laboratorios Cinfa S.A. | 83439 | COMPRIMIDO PARA CHUPAR | Sin Receta | Commercialized |
| HIBITANE 5 mg/5 mg COMPRIMIDOS PARA CHUPAR SABOR LIMON | Ionfarma S.L. | 72075 | COMPRIMIDO PARA CHUPAR | Sin Receta | Commercialized |
| TRUTEST 36 APOSITO ADHESIVO PARA PRUEBA DE PROVOCACION CON ALERGENOS | 85395 | APÓSITO ADHESIVO PARA PRUEBA DE PROVOCACIÓN CON ALERGENOS | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| LIZIPAINA CLORHEXIDINA 5 MG/BENZOCAINA 2,5 MG COMPRIMIDOS PARA CHUPAR | Opella Healthcare Spain S.L. | 12055 | COMPRIMIDO PARA CHUPAR | Sin Receta | Commercialized |
| FARINGESIC 5 mg/5 mg COMPRIMIDOS PARA CHUPAR SABOR MENTA | 44396 | COMPRIMIDO PARA CHUPAR | Sin Receta | Commercialized | |
| GARGARIL 5mg/2mg COMPRIMIDOS PARA CHUPAR | Industrias Farmaceuticas Puerto Galiano S.A. | 08697 | COMPRIMIDO PARA CHUPAR | Sin Receta | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.