Request that the FDA should convene an Advisory Committee to review the evidence on this issue and consider making the following recommendations: Change the non-prescription status for diphenhydramine, chlorpheniramine and any other centrally acting strongly anticholinergic OTC products to prescription only | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-7541

Request that the FDA should convene an Advisory Committee to review the evidence on this issue and consider making the following recommendations: Change the non-prescription status for diphenhydramine, chlorpheniramine and any other centrally acting strongly anticholinergic OTC products to prescription only

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensJul 8, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Reference 3. Coupland et al._2019	Jul 8, 2026	--

Keywords

CDER

Citizen Petition

convene an Advisory Committee to

review the evidence on this issue and

consider making the following recommendations

Change the non-prescription status

for diphenhydramine, chlorpheniramine

and any other centrally acting strongly

Data from Regulations.gov