Data Requests
The U.S. Food and Drug Administration (FDA) issues Data Requests for the submission
of data from the public to help inform certain future over-the counter (OTC) monograph
drug activities, including development of FDA-initiated proposed orders.
Click here for information regarding the process for FDA data requests to inform certain over-the-counter monograph drug activities
| 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 |