What is it used for?
Self-Care Framework Category I Uses or Purposes:
All products
For temporary relief of (minor) sore throat.
Temporarily relieves/soothes (minor) sore throat.
Products containing dl-menthol/l-menthol, phenol, hexylresorcinol, benzocaine, dyclonine hydrochloride, benzyl alcohol, salicyl alcohol
For temporary relief of pain of (minor) sore throat.
Temporarily relieves/soothes pain of (minor) sore throat.
Products containing slippery elm, gelatin, or pectin
For (the) protection of irritated area in the throat.
Protects irritated areas in the throat.
Products containing 2 - 20 mg of dl-menthol and/or l-menthol
Helps ease/relieve nasal congestion
Makes nasal passages feel clearer
Products containing 5 - 20 mg of dl-menthol and/or l-menthol
For (the) temporary relief of coughs.
Temporarily relieves/soothes coughs.
Products containing hexylresorcinol, cetylpyridinium chloride, domiphen bromide, phenol, or dequalinium chloride
Antiseptic
Who does this guide cover?
Children 6 to 11 years, Adolescents 12 to 17 years, Adults 18 years and older
How is it taken?
Oral
Which forms are covered?
Lozenge
How is it used?
Products containing dl-menthol/l-menthol, eucalyptus essential oil, gelatin, pectin or slippery elm
Dissolve 1 lozenge slowly in the mouth as needed.
Products containing hexylresorcinol, benzyl alcohol, dyclonine hydrochloride, cetylpyridinium chloride, domiphen bromide, dequalinium, salicyl alcohol or phenol
Dissolve 1 lozenge slowly in the mouth every 2 hours as needed.
Products containing benzocaine
Allow product to dissolve slowly in the mouth.
Do not bite, chew or swallow whole.
May be repeated every 2 hours as needed (or as directed by a healthcare professional) [Source note 3].
Use the smallest amount possible to achieve desired result.
Children under 12 years of age should be supervised by an adult in the use of this product [Source note 4].
How long is it used?
Products containing benzocaine
For occasional use only.
Warnings and precautions
All products
Keep out of reach of children. In case of overdose, call a poison control centre or get medical help right away.
Products including claim for the temporary relief of (minor) sore throat and/or temporary relief of pain of (minor) sore throat and/or irritated throat (except for products containing benzocaine)
Stop use and ask a healthcare professional if sore throat worsens or persists for more than 2 days.
Products including claim for the temporary relief of coughs
Stop use and ask a healthcare professional if cough worsens and persists for more than 7 days, or is accompanied by a fever.
Products containing ingredients in Tables 4 or 5
Ask a doctor/physician/healthcare professional before use if you are pregnant or breastfeeding.
Products containing benzocaine
When using this product do not chew gum or food while numbness persists [Source note 5].
Stop use and ask a healthcare professional if sore throat is severe, persists for more than 2 days, or is accompanied by or followed by other symptoms such as fever, headache, rash, swelling, nausea, or vomiting [Source note 6].
When should it be avoided?
Products containing benzocaine
Do not use if you are allergic to benzocaine.
Possible side effects
Products containing benzocaine
Stop use and ask a healthcare professional if the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue coloured skin. These symptoms may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use (US FDA 2018; US FDA 2011a,b; HC 2006).
Stop use if hypersensitivity/allergy occurs [Source note 7].
Storage
Must be established in accordance with the requirements described in the applicable product regulations or the Food and Drug Regulations.
Permitted combinations:
The concentration of each active ingredient per lozenge must not exceed its maximum value as listed in Tables 4, 5 and 6 above (e.g., 20 mg total dl-menthol/l-menthol + 15 mg eucalyptus essential oil).
dl-menthol/l-menthol + eucalyptus essential oil
dl-menthol/l-menthol + hexylresorcinol
benzocaine + cetylpyridinium chloride
benzocaine + dl-menthol/l-menthol
benzocaine + phenol
1 demulcent+ 1 anaesthetic/analgesic
1 demulcent + 1 antiseptic
supplements
| active ingredients | Methods of preparation | Quantity per lozenge | Maximum quantity/day | Maximum frequency/day |
|---|---|---|---|---|
| Benzyl alcohol | N/A | 100 - 500 mg | N/A | up to 8 times |
| Benzocaine | N/A | 2 - 15 mg | N/A | up to 6 times |
| Salicyl alcohol | N/A | 50 - 100 mg | N/A | up to 8 times |
| dl-Menthol and/or l-Menthol | N/A | 2 - 20 mg | N/A | up to 16 times |
| Phenol | N/A | 10 - 50 mg | 300 mg | up to 8 times |
| Gelatin | N/A | 2 - 100% | N/A | up to 16 times |
| Pectin | N/A | 2 - 100% | N/A | up to 16 times |
| Slippery elm | Powdered* | 200 - 300 mg | 6 g | up to 16 times |
| Eucalyptus essential oil | Oil, Essential (water steam distillation) | 0.2 - 15 mg | N/A | up to 16 times |
*Note: The method of preparation 'powdered' is defined as a dried and ground preparation (= unextracted).
Non-prescription drugs
See tables 4 and 5 above for NPD quantities per lozenge.
Preparation details
Ingredient identity, preparation requirements, and other details that define the scope of this guide.
active ingredients
Throat lozenges products are classified as supplements (NHPs) if they contain only ingredients from Table 1, 2 and 3. Applicants applying for an source product registration can access the appropriate forms and guidance at: [Source note 1]
Throat lozenges products are classified as non-prescription drugs (NPDs) if they contain at least one ingredient from Table 4 and 5. Applicants applying for a DIN can access the appropriate forms and guidance at: [Source note 2]
Ingredients and preparations
| Proper name(s) | Common name(s) | Source information / Source ingredient(s) | Source information / Source material(s) | Source information / Part(s) |
|---|---|---|---|---|
| alpha-Hydroxytoluene | Benzyl alcohol | Benzyl alcohol | N/A | N/A |
| 4-Aminobenzoic acid, ethyl ester | Benzocaine | Benzocaine | N/A | N/A |
| 2-Hydroxybenzenemethanol | Salicyl alcohol | Salicyl alcohol | N/A | N/A |
|
| dl-Menthol | N/A | N/A |
|
| l-Menthol | N/A | N/A |
|
| N/A | Mentha arvensis |
|
|
| N/A | Mentha canadensis | Herb top |
|
| N/A | Mentha x piperita |
|
| Phenol | Phenol | Phenol | N/A | N/A |
| Proper name(s) | Common name(s) | Source information / Source ingredient(s) | Source information / Source material(s) | Source information / Part(s) |
|---|---|---|---|---|
| Gelatin |
| Gelatin | N/A | N/A |
| Pectin | Pectin | N/A | Citrus aurantiifolia |
|
| Pectin | Pectin | N/A | Citrus limon |
|
| Pectin | Pectin | N/A | Citrus maxima | Fruit |
| Pectin | Pectin | N/A | Citrus paradisi |
|
| Pectin | Pectin | N/A | Citrus reticulata | Fruit |
| Pectin | Pectin | N/A | Citrus sinensis |
|
| Pectin | Pectin | N/A | Malus domestica | Fruit |
| Ulmus rubra |
| N/A | Ulmus rubra | Stem bark inner¹ |
¹Preparation : Dry.
| Proper name(s) | Common name(s) | Source information / Source material(s) | Source information / Part(s) |
|---|---|---|---|
| Eucalyptus globulus |
| Eucalyptus globulus | Leaf |
¹See permitted combinations.
| Proper name(s) | Common name(s) | Quantity per lozenge |
|---|---|---|
| 4-n-Butoxy-beta-(1-piperidyl)propiophenone hydrochloride | Dyclonine hydrochloride | 1-3 mg |
| Hexylresorcinol | 2-4 mg |
| Proper name(s) | Common name(s) | Quantity per lozenge |
|---|---|---|
| 1-Hexadecylpyridinium chloride | Cetylpyridinium chloride(antiseptic) | 1-2 mg |
| Dequalinium chloride (antiseptic) | 0.25 mg |
| Domiphen bromide(antiseptic) | 1.5 mg |
| Hexylresorcinol (analgesic/anesthetic/antiseptic) | 2-4 mg |
Other ingredients
Ingredients must be chosen from the current source ingredient database and must meet the limitations outlined in that database, the Food and Drug Regulations (FDR), and the current Cosmetic Ingredient Hotlist, when relevant.
Preparation and quality requirements
this reference describes those requirements that are specific to this class of non-prescription drugs and to supplements. Any change to the manufacturing process that impacts the safety and efficacy of the ingredients, such as the use of novel technology (e.g. nanotechnology), requires supporting data and will be reviewed outside the reference.
For products containing Table 1, 2 and 3 NHP active ingredients only:
The finished product specifications must be established in accordance with the requirements described in the source authority source’s product quality guidance. The active ingredient must comply with the requirements outlined in the source ingredient database.
For products containing Table 4 and 5 NPD active ingredients:
Requirements described in the Regulations to the Food and Drugs Act must be met.
Guide change history
Updates to this SupplementSafety.org guide.
Minor updates
Updated guide wording, organization, and source presentation. Added our editorial change history.
Initial release
Initial SupplementSafety.org guide prepared from source reference material.
Validation: Not yet completed. Editorial updates do not constitute clinical validation.
Sources
Source information
This guide organizes source material about uses, preparations, amounts, and precautions. Read the conditions alongside each statement; the information may apply only to particular preparations or populations.
The source document includes supporting references. We have not independently summarized or assessed every cited study for this guide.
- Source document version
- 2024-11-29 Foreword This monograph is intended to replace the existing Throat lozenges Monograph of December 7, 2018. This monograph describes the requirements necessary to receive market authorization [i.e. a Drug Identification Number (DIN) or a Natural Product Number (NPN)], for throat lozenges products. The monograph identifies the permitted medicinal and non-medicinal ingredients, concentrations, indications, directions and conditions of use for these products to be market authorized without the submission to Health Canada of additional evidence. It also may contain the test methods recommended to be used to comply with the requirements of this monograph. Products which do not meet the criteria outlined in this document can apply for market authorization outside of the monograph stream. Applicants are reminded that throat lozenges products, like other non-prescription drugs or natural health products, are subject to the Food and Drug Regulations or the Natural Health Products Regulations administered by the Natural and Non-prescription Health Products Directorate (NNHPD). This includes requirements related to labelling, manufacturing and product specifications. Additional information on labels, outside of those specified in the monograph, such as additional directions for use and/or non-therapeutic claims are acceptable as long as they meet the Guidelines for the Nonprescription and Cosmetic Industry Regarding Non-therapeutic Advertising and Labelling Claims, the Guidelines for Consumer Advertising of Health products for Nonprescription drugs, Natural Health Products, Vaccines and Medical Devices, and are not false, misleading or counterintuitive to the use of the product. The development of this monograph is the result of a thorough review of existing regulations, guidance documents, policies and current practices within Health Canada and other leading regulatory agencies. Notes Text in parentheses is additional optional information which can be included on the label at the applicant's discretion. The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant on the label.
- Source captured
- Aug 15, 2026
- Editorial work
- Editorial preparation. Independent clinical review has not been recorded for this guide.
Full citations are available through the link above. Verification is required to open them; reading this guide does not require verification.
Taking a medication too?
Explore our supplement–medication interaction checker. Its coverage and review status are shown with the results; a missing finding does not establish that a combination is safe.