An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Historical Status of OTC Rulemakings

Rulemaking History for OTC Anticaries Drug Products

Final Monograph (21 CFR part 355):
Anticaries Drug Products for Over-the-Counter Human Use

OTC Anticaries Drug Products found on this page:

Original Active Ingredients and Labeling
Nonmonograph Ingredients
Final Formulation Testing
Fluoride Labeling
Intraoral Appliance Models
Package Size Limitation

Anticaries Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice Of Proposed Rulemaking	3/28/1980	45FR20666
Correction	5/20/1980	45FR33650
Proposed Rule	Date	FR Citation
Tentative Final Monograph	9/30/1985	50FR39854
Correction	10/24/1985	50FR43233
Extension of Comment Period	2/21/1989	54FR7448
Final Rule	Date	FR Citation
Final Monograph	10/6/1995	60FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning	10/7/1996	61FR52285

Anticaries Drug Products: Nonmonograph Ingredients

Proposed Rule	Date	FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph	5/16/1990	55FR20434
Correction	6/7/1990	55FR23235
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph	11/7/1990	55FR46914
Correction	12/3/1990	55FR49973
Technical Amendment: Corrects an ingredient name	1/30/1992	57FR3526

Anticaries Drug Products: Final Formulation Testing

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Public Meeting	8/26/1983	48FR38853
Extension of Comment Period	10/25/1983	48FR49304
Proposed Rule	Date	FR Citation
Proposed Rule	6/15/1988	53FR22430
Extension of Comment Period	2/21/1989	54FR7448
Final Rule	Date	FR Citation
Final Monograph	10/6/1995	60FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning	10/7/1996	61FR52285

Anticaries Drug Products: Fluoride Labeling

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	11/24/1992	57FR55199
Extension of Comment Period	1/26/1993	58FR6102
Final Rule	Date	FR Citation
Final Monograph	10/6/1995	60FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning	10/7/1996	61FR52285

Anticaries Drug Products: Intraoral Appliance Models

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data: To comply with biological testing requirements	10/15/2001	66FR52418
Reopening of Comment Period	3/15/2002	67FR11704

Package Size Limitation

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	5/8/1992	57FR19823
Correction	5/19/1992	57FR21332
Final Rule	Date	FR Citation
Final Monograph	10/6/1995	60FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning	10/7/1996	61FR52285

Top