Duraphat fluoride varnish for caries control

Colgate explains the product licence, evidence and application considerations for Duraphat fluoride varnish in caries control.

Dental teams have access to a wide range of professional products to support caries prevention, including fluoride varnish. It is important to understand that not all fluoride varnishes are intended for the same use. The distinction can be identified by their regulatory status, as defined by the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA defines a medicine as a substance or combination of substances presented as having properties for treating or preventing disease in people (MHRA, 2021). A medical device’s principal mode of action does not include treating or preventing disease (MHRA, 2021).

According to Colgate, Duraphat fluoride varnish is the only fluoride varnish with the legal status of a medicine and a licence for caries control. Colgate says that other fluoride varnishes currently on the UK market are medical devices intended to treat hypersensitive teeth, rather than caries control. The manufacturer says that medical devices act primarily by physical or mechanical means, while medicines act through pharmacological, metabolic or immunological effects.

Why does this matter?

Delivering better oral health guidance recommends applying 22,600 ppm fluoride varnish twice a year for caries prevention in children aged three years and over (OHID, 2021). This increases to three-monthly applications for patients at increased caries risk. For adults at increased caries risk, guidance may recommend an application every three or six months, depending on their caries pathway (OHID, 2021; DHSC, 2025; NHS England, 2025).

Colgate says that using a fluoride varnish licensed for caries control supports dental practitioners’ responsibilities as prescribers. It says this is also relevant to appropriately trained extended duties dental nurses and to dental hygienists and dental therapists working to exemptions (NHS England, 2016; NHS England, 2025).

Transparent information

Colgate says that its Duraphat fluoride varnish product licence information is publicly accessible through the MHRA website (MHRA, 2026). This includes the Summary of Product Characteristics, which the manufacturer says can help dental professionals make an informed choice before application.

The product information lists the following indications:

• Prevention of caries in children and adults as part of a comprehensive control programme
• Prevention of recurring or marginal caries
• Prevention of progression of caries
• Prevention of decalcification around orthodontic appliances
• Prevention of pit and fissure occlusal caries.

This prescribing information is also available in an abridged form on marketing materials for Duraphat fluoride varnish.

Application

Before applying Duraphat fluoride varnish, advise the patient, parent or carer about its purpose, benefits, process, possible side effects and alternatives. Ensure that the patient has eaten before the application, and explain that the varnish is applied with a small brush. Colgate says that the application is quick, simple and painless, and that the varnish has a raspberry taste.

According to Colgate, the opaque yellow tint of Duraphat fluoride varnish is temporary. It wears off or can be brushed off after four hours if desired. The manufacturer says that this tint can be a useful application guide, including when treating a fidgety child.

Other fluoride varnishes that are not licensed for caries control can offer a range of flavours intended to engage children. Colgate says this could imply that such products can be used for caries control. A review of flavoured fluoride varnishes found that flavour was not an effective way to engage a child. Instead, it suggested offering a choice of safety glasses or asking which side of the arch they would like to start on, to give the child an element of control (Cunningham and Linden, 2025).

It is increasingly important to consider fluoride varnish application for adults at higher caries risk. This includes the planned caries pathways for higher-risk adults proposed as part of the latest dental reform, aligned with the 10-year NHS plan (NHS England, 2026, NHS England, 2025).

For more information, visit Colgate’s Duraphat fluoride varnish page.

† Duraphat fluoride varnish is for patients aged three years and over.

References

1. Borderline products: how to tell if your product is a medicine.
2. Borderline products: how to tell if your product is a medical device.
3. Delivering better oral health: an evidence-based toolkit for prevention, Office for Health Improvement and Disparities, 2021.
4. Dental contract quality and payment reforms, DHSC consultation webinar, Tuesday 15 July 2025.
5. Avoidance of doubt: application of fluoride varnish by dental nurses. Chief Dental Officer, NHS England, 2016.
6. Supply and administration of medicines by dental hygienists and dental therapists. NHS England, 2025.
7. MHRA Products.
8. Cunningham B, Linden J. Using flavour in your favour: does giving children an element of control help them engage more positively with the dental experience? Evid Based Dent 26, 97–98 (2025).
9. NHS dentistry quality and payment reforms contractual guidance.
10. Fit for the Future: 10 Year Health Plan for England. NHS England, 2025.

This article is sponsored by Colgate