Data Request Details
Data Request DR001: Use of the pH Cycling Test Model as a Testing Procedure for Fluoride Dentifrice Drug Products in Over-the-Counter (OTC) Monograph M021: Anticaries Drug Products for Over-the-Counter Human Use
Summary
FDA is announcing this Data Request for the submission of data from the public to help inform whether the pH cycling test model should be included as a testing procedure for fluoride dentifrice drug products under Over-the-Counter (OTC) Monograph M021: Anticaries Drug Products for Over-the-Counter Human Use (OTC Monograph M021).
You may submit data electronically in docket number FDA-2026-N-7864 in the Federal eRulemaking Portal at https://www.regulations.gov/. See the Data Request for instructions. Data submissions will be accepted at any time beginning on July 28, 2026 until 11:59 pm Eastern Time at the end of January 25, 2027.
| ID | Published Date | Title | Comments Due Date | Ingredients | Therapeutic Category | Applicable OTC Monograph |
|---|---|---|---|---|---|---|
| DR0001 | 07/28/2026 | Use of the pH Cycling Test Model as a Testing Procedure for Fluoride Dentifrice Drug Products in Over-the-Counter (OTC) Monograph M021: Anticaries Drug Products for Over-the-Counter Human Use. | 01/25/2027 | Sodium Fluoride; Sodium Monofluorophosphate; Stannous Fluoride | Anticaries | Over-the-Counter Monograph M021: Anticaries Drug Products for Over-the-Counter Human |