FDA is issuing this proposed administrative order (proposed order) to amend the requirements for cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter (OTC) human use, as currently described in Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use (OTC Monograph M012). This proposed order, if finalized, will amend OTC Monograph M012 to remove orally administered phenylephrine hydrochloride and phenylephrine bitartrate in an effervescent dosage as nasal decongestant active ingredients because they are not effective. You may submit comments on this proposed order [OTC000036] electronically in docket number FDA-2024-N-4734 in the Federal eRulemaking Portal at https://www.regulations.gov/. See the proposed order for instructions. Comments will be accepted at any time beginning on November 8, 2024 until 11:59 pm Eastern Time at the end of May 7, 2025. The Scientific Review Supporting Proposed Administrative Order OTC000036 can be viewed under the Supporting Documents.
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