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FDANonrulemakingFDA-2024-N-4734

Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use

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Dec 12, 2025
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closed 447d ago
National Association of Chain Drug Stores filings
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National Association of Chain Drug Stores filed 1 comment on this docket between May 28, 2025 and May 28, 2025. 1 other organizations filed here. The comment window closed 447d ago.

What National Association of Chain Drug Stores filed (1)

May 28, 2025· Comment from National Association of Chain Drug Stores (NACDS)· FDA-2024-N-4734-2792

Please see the attached comments of the National Association of Chain Drug Stores regarding the Proposed Order OTC000036 to remove orally administered phenylephrine from the Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. We thank FDA for considering feedback on this matter.

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Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use (FDA) — National Association of Chain Drug Stores | OpenPolis