Overview
Amylmetacresol is an antiseptic available in Canada over-the-counter in a number of lozenges for the treatment of sore throat and minor mouth infections , . Amylmetacresol is often combined with dichlorobenzyl alcohol and menthol in the commonly used sore throat lozenges, known as Strepsils . The acute sore throat (pharyngitis) is one of the most common conditions for which children are seen in the primary care setting. Pharyngitis is normally caused by viruses and proves benign and self-limiting. Clinically proven, over-the-counter throat lozenges offer rapid and effective relief of acute sore throat symptoms, and are increasingly important in the management of this condition .
Indication
Sore throat, minor mouth and throat infections , , .
Associated Conditions
- Canker sores oral
- Gingivitis
- Inflammatory Disease of the Oral Cavity
- Inflammatory Disease of the throat
- Laryngitis
- Pain, Orofacial
- Pharyngitis
- Sore Throat
- Stomatitis
- Mouth soreness
- Oral infections
- Pain in throat
- Sore throat and hoarseness
- Throat infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
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 |
|---|---|---|---|---|---|
| STREPSILS MAX PLUS LOZENGES | SIN08806P | LOZENGE | 0.6 mg | 7/11/1996 |
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 |
|---|---|---|---|---|---|
| BETACARE SORE THROAT HONEY & LEMON LOZENGES 0.6MG/1.2MG | N/A | N/A | N/A | 3/29/2022 | |
| DIFFLAM ANTISEPTIC LOZENGES HONEY LEMON FLAVOUR | N/A | N/A | N/A | 8/31/2022 | |
| BETACARE SORE THROAT ORANGE LOZENGES 0.6MG/1.2MG | N/A | N/A | N/A | 5/3/2022 | |
| BETACARE SORE THROAT MENTHOL & EUCALYPTUS LOZENGES 0.6MG/1.2MG | N/A | N/A | N/A | 3/29/2022 | |
| DIFFLAM ANTISEPTIC LOZENGES BLACKCURRANT FLAVOUR | N/A | N/A | N/A | 8/31/2022 | |
| DIFFLAM ANTISEPTIC LOZENGES ORANGE FLAVOUR | N/A | N/A | N/A | 8/31/2022 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| STREPSILS ANAESTHETIC THROAT SPRAY bottle | 55908 | Medicine | A | 6/13/1996 | |
| TERRY WHITE CHEMISTS DOUBLE ANTIBACTERIAL LOZENGES HONEY & LEMON blister pack | 221977 | Medicine | A | 4/3/2014 | |
| MEDI CHOICE DOUBLE ANTIBACTERIAL LOZENGES honey & lemon flavour lozenges blister pack | 204136 | Medicine | A | 12/17/2012 | |
| VOCASEPT PLUS LOZENGES - Honey Lemon | 383601 | Medicine | A | 2/7/2022 | |
| MEDI CHOICE DOUBLE ANTIBACTERIAL LOZENGES menthol & eucalyptus flavour lozenges blister pack | 204135 | Medicine | A | 12/17/2012 | |
| VOCASEPT THROAT SUGAR FREE LOZENGES Lemon lozenges blister pack | 383022 | Medicine | A | 1/24/2022 | |
| STREPSILS SUGAR FREE LEMON lozenge (reformulation) blister pack | 153118 | Medicine | A | 6/16/2008 | |
| COLES DOUBLE ANTI-BACTERIAL LOZENGES HONEY & LEMON FLAVOUR blister pack | 280980 | Medicine | A | 10/4/2016 | |
| BETADINE SORE THROAT LOZENGES honey & lemon flavour blister pack | 487551 | Medicine | A | 5/2/2025 | |
| MEDIX PINEAPPLE Lozenges blister pack | 204008 | Medicine | A | 12/13/2012 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| STREPSILS | reckitt benckiser (canada) inc | 02236583 | Lozenge - Oral | 0.6 MG | 8/20/1998 |
| STREPSILS CHERRY | reckitt benckiser (canada) inc | 02240065 | Lozenge - Oral | 0.6 MG | 8/1/2001 |
| STREPSILS - LOZ | knoll pharma inc. | 02177455 | Lozenge - Oral | 0.6 MG | 12/31/1996 |
| SORE THROAT LOZENGES | herbion canada | 02514583 | Lozenge - Oral | 0.6 MG | N/A |
| STREPSILS SORE THROAT BLOCKED NOSE | reckitt benckiser (canada) inc | 02238543 | Lozenge - Oral | 0.6 MG | 7/29/2008 |
| STREPSILS STRAWBERRY SUGARFREE | reckitt benckiser (canada) inc | 02267896 | Lozenge - Oral | 0.6 MG | 3/23/2007 |
| CEPACOL SENSATIONS COOLING | reckitt benckiser (canada) inc | 02382865 | Lozenge - Oral | 0.6 MG | 7/19/2012 |
| ANTIBACTERIAL THROAT LOZENGES | quimica canada limited | 02375567 | Lozenge - Oral | 0.6 MG | 3/7/2013 |
| CEPACOL CHILDREN'S FRUITY STRAWBERRY | rb health (canada) inc. | 02404982 | Lozenge - Oral | 0.6 MG | 8/15/2013 |
| CEPACOL SENSATIONS SORE THROAT & COUGH | rb health (canada) inc. | 02388642 | Lozenge - Oral | 0.6 MG | 9/4/2012 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| STREPSILS PASTILLAS PARA CHUPAR SABOR MIEL Y LIMON | Reckitt Benckiser Healthcare S.A. | 56418 | PASTILLA PARA CHUPAR | Sin Receta | Commercialized |
| STREPSILS PASTILLAS PARA CHUPAR SABOR MIEL Y LIMON | PL 00063-0397 | PASTILLA PARA CHUPAR | Sin Receta | Not Commercialized | |
| BUCOMAX CON LIDOCAINA PASTILLAS PARA CHUPAR SABOR NARANJA | Laboratorios Cinfa S.A. | 76952 | PASTILLA PARA CHUPAR | Sin Receta | Commercialized |
| BUCOMAX CON LIDOCAINA PASTILLAS PARA CHUPAR SABOR MIEL Y LIMON | Laboratorios Cinfa S.A. | 76949 | PASTILLA PARA CHUPAR | Sin Receta | Commercialized |
| STREPSILS pastillas para chupar sabor limon | Reckitt Benckiser Healthcare S.A. | 76814 | PASTILLA PARA CHUPAR | Sin Receta | Commercialized |
| STREPSILS pastillas para chupar sabor menta | Reckitt Benckiser Healthcare S.A. | 56417 | PASTILLA PARA CHUPAR | Sin Receta | Commercialized |
| FARINSTOP SPRAY SOLUCION PARA PULVERIZACION BUCAL | 85434 | SOLUCIÓN PARA PULVERIZACIÓN BUCAL | Sin Receta | Commercialized | |
| BUCOMAX PASTILLAS PARA CHUPAR SABOR FRESA | Laboratorios Cinfa S.A. | 78851 | PASTILLA PARA CHUPAR | Sin Receta | Not Commercialized |
| STREPSILS CON LIDOCAINA PASTILLAS PARA CHUPAR | Reckitt Benckiser (Belgium)S.A/N.V. Ou Reckitt Benckiser Healthcare (Belgium) N.V./S.A. | BE207462 | PASTILLA PARA CHUPAR | Sin Receta | Commercialized |
| BUCOMAX PASTILLAS PARA CHUPAR SABOR MENTA | Laboratorios Cinfa S.A. | 78850 | PASTILLA PARA CHUPAR | Sin Receta | 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. | |||||
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