Essential medicine status
ATC codes: A01AA01 A01AA04
Dental caries ICD11 code: DA08.0
Medicine type
Chemical agent
List type
Core (EML)
Local > Dental > Gel: 2500 to 12500 ppm fluoride (any type)
Local > Dental > Toothpaste, cream or gel: 1000 to 1500 ppm fluoride (any type)
Local > Dental > Mouthrinse: 230 to 900 ppm fluoride (any type)
Local > Dental > Varnish: 22500 ppm fluoride (any type)
EML status history
First added in 1979 (TRS 641)
Changed in 1993 (TRS 850)
Changed in 2005 (TRS 933)
Changed in 2007 (TRS 950)
Changed in 2021 (TRS 1035)
Changed in 2023 (TRS 1049)
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
The Expert Committee recalled the request made by the 2021 Committee for WHO to identify the alternative fluoride-containing formulations recommended for use in the prevention of dental caries in order that they be clearly defined in the Model Lists to provide clear guidance to countries. The Committee considered that the evidence presented in the applications for fluoride gel, mouthrinse and varnish supported the effectiveness and safety of these products in the prevention of dental caries, and therefore recommended their inclusion on the core list of the EML and EMLc, as specific fluoride-containing formulations.