Rulemaking History for OTC Expectorant Drug Products

Final Monograph(21 CFR part 341):
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use

FDA Archive-It webpage:

Search for Federal Register documents:

OTC Expectorant Drug Products found on this page:

Expectorant Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking9/9/197641FR38312
   Reopening of Administrative Record3/21/198045FR18400
   Reopening of Administrative Record9/26/198045FR63874
Proposed RuleDateFR Citation
Tentative Final Monograph7/9/198247FR30002
   Extension of Comment Period8/27/198247FR37934
Final RuleDateFR Citation
Final Monograph2/28/198954FR8494
   Technical Amendment: Replaces "sputum" with "mucus" in indication6/30/199257FR29176
Final Rule: Classifies ipecac as nonmonograph9/14/199257FR41857

Expectorant Drug Products: Combination Products

Proposed RuleDateFR Citation
Proposed Rule: Miscellaneous combinations8/12/198853FR30522
   Clarification: Includes promethazine HCl combinations11/14/198853FR45774
Notice: Prohibits OTC marketing of promethazine HCl combinations9/5/198954FR36762
Reopening of Administrative Record: Promethazine HCl combinations11/28/198954FR48914
  Extension of Comment Period1/24/199055FR2387
Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph7/13/200570FR40232

Expectorant Drug Products: Pediatric Use

Proposed RuleDateFR Citation
Notice: Advisory Committee Meeting8/16/200772FR46091
Amendment of Notice: Advisory Committee Meeting10/1/200772FR55784
Notice of Public Hearing: Request for comments8/25/200873FR50033
Notice of Public Hearing: Correction9/2/200873FR51309


Page Last Updated: 12/01/2016
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