Annual Forecast for Planned Monograph Activities
Posted Date: September 2, 2025
The over-the-counter (OTC) monograph annual forecast is a nonbinding list, issued each year, of planned monograph activities that FDA intends to initiate over the ensuing 3 years. These planned monograph activities will generally include expected FDA-initiated proposed administrative orders (proposed orders) to add, remove, or change generally recognized as safe and effective (GRASE) conditions for OTC drug monographs including GRASE determinations for drugs marketed under 505G(a)(1) and 505G(a)(2) of the Federal Food, Drug and Cosmetic Act. Planned monograph activities may also include other activities such as safety and efficacy reviews, meetings with requestors, and requests for data. The forecast is intended to provide stakeholders with advance notice of activities FDA intends to initiate over the ensuing 3 years and in turn to place on the forecast is generally guided by public health priorities. FDA may consider information from a variety of sources including but not limited to literature, FDA Adverse Event Reporting System (FAERS), or data and information submitted to FDA in determining which activities it intends to initiate. The order of topics in the forecast does not reflect planned chronological order of FDA actions, or order of public health importance.
| FDA-Initiated Proposed Orders | ||
|---|---|---|
| Topic | Activity Description | OTC Monograph Number |
| Risks Associated with Codeine-Containing Cough Medicine1 | Addresses the generally recognized as safe and effective (GRASE) status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients | M012 |
| Pediatric Acetaminophen Dosing | Addresses dosage strengths of oral, single ingredient pediatric acetaminophen products. Proposes addition of weight- and age-based dosing for children under age 12 years |
M013 |
| Risks Associated with Propylhexedrine Abuse and Misuse | Proposes addition of a warning for propylhexedrine-containing drug products to inform consumers of serious health risks with abuse and misuse | M012 |
| Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and Oligohydramnios | Proposes updated pregnancy labeling for NSAID containing drug products | M013 |
| Oral Healthcare in Infants and Children | Addresses the GRASE status of OTC oral healthcare drug products containing benzocaine and/or phenol preparations labeled for anesthetic/analgesic indications | M022 |
| Risks Associated with Use of Ipecac Syrup as OTC Poison Treatment | Addresses the GRASE status of OTC ipecac labeled for poison treatment | M023 |
| Pediatric Cough/Cold Dosing1 | Re-assesses the risks and benefits of cough/cold drug products in children under age 6 years | M012 |
| Requests for Data | ||
|---|---|---|
| Topic | Activity Description | OTC Monograph Number |
| Anticaries Test Methods2,3 | Requesting data to support the inclusion of the pH cycling test as an acceptable anticaries test method | M021 |
1This is part of a series of actions to be proposed by FDA as part of its ongoing evaluation of the safety and efficacy of pediatric cough cold drug products marketed under the OTC Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use.
2FDA recommends sponsors or requestors request a formal meeting to obtain FDA feedback on the acceptability of data and adequacy of the OTC monograph order development program to support potential new test methods.
3At a later date, FDA will announce a request for the submission of data and information from the public on this topic. When announced, complete details on the request for data, including how to submit those data, will be available on the OTC Monographs@FDA portal at http://www.accessdata.fda.gov/scripts/cder/omuf.