Overview
Benzydamine (also known as Tantum Verde or Difflam), available as the hydrochloride salt, is a locally-acting nonsteroidal anti-inflammatory drug (NSAID) with local anaesthetic and analgesic properties. It is used topically for pain relief and anti-inflammatory treatment of the mouth, throat, or muscoskeletal system. Although the indazole analogue benzydamine is a non-steroidal anti-inflammatory drug (NSAID), it has various physicochemical properties and pharmacologic activities that are different from those of traditional aspirin-like NSAIDs but facilitate benzydamine's mechanism of action as an effective locally-acting NSAID with local anaesthetic and analgesic properties. Moreover, unlike aspirin-like NSAIDs which are acids or metabolised to acids, benzydamine is in fact a weak base.
Indication
Available predominantly as a liquid mouthwash, oromucosal spray, or topical cream, benzydamine is most frequently employed as a locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions. When formulated as a mouthwash or spray, benzydamine may be used to treat traumatic conditions like pharyngitis following tonsillectomy or the use of a naso-gastric tube, inflammatory conditions like pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy, dentistry operations and procedures, or more general conditions like sore throat, sore tongue, sore gums, mouth ulcers, or discomfort caused by dentures. When used as a topical cream, benzydamine may be employed to relieve symptoms associated with painful inflammatory conditions of the muscolo-skeletal system including acute inflammatory disorders such as myalgia and bursitis or traumatic conditions like sprains, strains, bruises, sore muscles, stiff joints, or even the after-effects of fractures.
Associated Conditions
- Acute Sore Throat
- Gingivitis
- Inflammation of Mouth
- Laryngitis
- Mouth irritation
- Mucositis of the oro-pharyngeal
- Pain
- Pain, Orofacial
- Pharyngitis
- Sore gums
- Throat irritation
- Traumatic Injuries caused by Dental Prosthesis
- Gum irritation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/06 | Early Phase 1 | Not yet recruiting | KK Women's and Children's Hospital | ||
2022/04/25 | Phase 4 | UNKNOWN | Rehman Medical Institute - RMI | ||
2022/04/21 | Phase 1 | ENROLLING_BY_INVITATION | |||
2022/04/12 | Phase 2 | UNKNOWN | |||
2021/09/24 | Phase 4 | Completed | Aziende Chimiche Riunite Angelini Francesco S.p.A | ||
2021/06/28 | Phase 4 | Completed | Aziende Chimiche Riunite Angelini Francesco S.p.A | ||
2019/11/19 | Not Applicable | Completed | |||
2018/11/19 | Phase 4 | Completed | Near East University, Turkey | ||
2017/09/13 | Phase 3 | Completed | |||
2017/03/09 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| DIFFLAM LOZENGE 3 mg | SIN07411P | LOZENGE | 3 mg | 4/29/1993 | |
| Difflam Forte Anti-Inflammatory Throat Spray | SIN13625P | SPRAY | 3.0mg/mL | 4/2/2009 | |
| Difflam plus ANAESTHETIC Sore Throat Lozenges (Sugar Free) Honey Lemon Flavour | SIN15585P | LOZENGE | 3.0mg | 11/29/2018 | |
| Difflam For Children Throat Spray | SIN13626P | SPRAY | 1.5mg/mL | 4/2/2009 | |
| DIFFLAM MOUTH GEL | SIN09963P | GEL | 10 mg/g | 8/28/1998 | |
| DIFFLAM SOLUTION 22.5 mg/15 ml | SIN04232P | MOUTHWASH | 22.5 mg/15 ml | 4/23/1990 | |
| DIFFLAM-C ANTI-INFLAMMATORY ANTISEPTIC SOLUTION | SIN08671P | MOUTHWASH | 22.5 mg/15 ml | 4/24/1996 | |
| EASIFLAM MOUTHWASH 0.15% W/V | SIN16801P | MOUTHWASH | 0.15% w/v | 5/31/2023 | |
| Difflam™ Anti-inflammatory Lozenge (with antibacterial) (Eucalyptus and Menthol) | SIN13591P | LOZENGE | 3.0mg | 1/22/2009 | |
| DIFFLAM ANTI-INFLAMMATORY LOZENGE (WITH ANTIBACTERIAL) (HONEY LEMON) | SIN12320P | LOZENGE | 3 mg | 6/13/2003 |
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 |
|---|---|---|---|---|---|
| DIFFLAM ANTI-INFLAMMATORY ANTI-BACTERIAL LOZENGES DOUBLE MINT FLAVOUR | N/A | N/A | N/A | 1/12/2009 | |
| DIFFLAM WITH ANAESTHETIC SORE THROAT LOZENGES MENTHOL & EUCALYPTUS FLAVOUR | N/A | N/A | N/A | 5/27/2022 | |
| ZUHOTAN SPRAY 1.5MG/ML | N/A | N/A | N/A | 2/8/2010 | |
| DIFFLAM FORTE ANTI-INFLAMMATORY THROAT SPRAY 0.3% | N/A | N/A | N/A | 1/18/2008 | |
| DIFFLAM MOUTH GEL | N/A | N/A | N/A | 8/9/2004 | |
| DIFFLAM SOLN FOR GARGLE 0.15% | N/A | N/A | N/A | 5/4/1989 | |
| DIFFLAM ANTI-INFLAM ANTIBACTERIAL LOZ (HONEY LEMON) | N/A | N/A | N/A | 6/22/2005 | |
| DIFFLAM ANTI-INFLAMMATORY ANTI-BACTERIAL LOZENGES EUCALYPTUS & MENTHOL FLAVOUR | N/A | N/A | N/A | 1/12/2009 | |
| DIFFLAM ANTI-INFLAM ANTIBACTERIAL LOZ (ORANGE) | N/A | N/A | N/A | 6/22/2005 | |
| DIFFLAM ANTI-INFLAMMATORY THROAT SPRAY 0.15% | N/A | N/A | N/A | 1/18/2008 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DIFFLAM ANTI-INFLAMMATORY + ANTIBACTERIAL raspberry flavour lozenge blister pack | 280644 | Medicine | A | 9/23/2016 | |
| MEDIX Anaesthetic Lozenges Honey & Lemon Flavour blister pack | 288299 | Medicine | A | 4/26/2017 | |
| MEDIX Anaesthetic Lozenges Menthol Flavour blister pack | 288298 | Medicine | A | 4/26/2017 | |
| COLES ANAESTHETIC LOZENGES MENTHOL FLAVOUR blister pack | 293037 | Medicine | A | 8/21/2017 | |
| DIFFLAM SORE THROAT SPRAY ANTI-INFLAMMATORY FORTE benzydamine hydrochloride 3mg/mL pump actuated metered dose aerosol bottle | 114417 | Medicine | A | 11/12/2004 | |
| DIFFLAM SORE THROAT FRESH MINT SUGAR FREE LOZENGES blister pack | 58319 | Medicine | A | 1/20/1997 | |
| CHEMISTS' OWN SORE THROAT LOZENGES raspberry flavour blister pack | 127495 | Medicine | A | 5/2/2006 | |
| BETADINE Anaesthetic Lozenges Menthol Flavour blister pack | 288301 | Medicine | A | 4/26/2017 | |
| PHARMACY HEALTH SORE THROAT LOZENGES PLUS ANAESTHETIC Menthol Flavour blister pack | 302681 | Medicine | A | 5/7/2018 | |
| DUROFLAM Sore Throat Lozenges - Honey Lemon | 346982 | Medicine | A | 11/2/2020 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| APO-BENZYDAMINE ORAL RINSE | 02239044 | Mouthwash/Gargle - Buccal | 0.15 % | 11/9/1998 | |
| ODAN-BENZYDAMINE | odan laboratories ltd | 02463105 | Mouthwash/Gargle - Buccal | 0.15 % / W/V | 8/11/2017 |
| PMS-BENZYDAMINE | 02239537 | Mouthwash/Gargle - Buccal | 0.15 % / W/V | 4/30/1999 | |
| RATIO-BENZYDAMINE | ratiopharm inc division of teva canada limited | 02230170 | Solution - Oral | 0.15 % | 3/24/1997 |
| PHARIXIA | pendopharm division of pharmascience inc | 02229777 | Mouthwash/Gargle - Buccal | 0.15 % / W/V | 12/2/1996 |
| SUN-BENZ - LIQ 0.15% | 02226820 | Liquid - Dental
,
Oral | .15 % | 4/3/1997 | |
| NOVO-BENZYDAMINE | novopharm limited | 02310422 | Mouthwash/Gargle
,
Solution - Buccal
,
Oral | 1.5 MG / ML | 6/3/2008 |
| NU-BENZYDAMINE ORAL RINSE | nu-pharm inc | 02238794 | Liquid - Buccal | 0.15 % | N/A |
| PHARIXIA ALCOHOL FREE | pendopharm division of pharmascience inc | 02494434 | Mouthwash/Gargle - Buccal | 0.15 % / W/V | 7/13/2020 |
| TANTUM | bausch health, canada inc. | 01966065 | Mouthwash/Gargle - Buccal | 0.15 % / W/V | 12/31/1993 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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.