U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Development Resources
  5. Over-the-Counter (OTC) Drugs
  6. Status of OTC Rulemakings
  7. Rulemaking History for OTC Expectorant Drug Products
  1. Status of OTC Rulemakings

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 Rulemaking9/9/197641FR38312disclaimer icon
   Reopening of Administrative Record3/21/198045FR18400disclaimer icon
   Reopening of Administrative Record9/26/198045FR63874disclaimer icon
Proposed RuleDateFR Citation
Tentative Final Monograph7/9/198247FR30002disclaimer icon
   Extension of Comment Period8/27/198247FR37934disclaimer icon
Final RuleDateFR Citation
Final Monograph2/28/198954FR8494disclaimer icon
   Correction3/22/198954FR11866disclaimer icon
   Technical Amendment: Replaces "sputum" with "mucus" in indication6/30/199257FR29176disclaimer icon
Final Rule: Classifies ipecac as nonmonograph9/14/199257FR41857disclaimer icon
   Correction10/6/199257FR46067disclaimer icon

Expectorant Drug Products: Combination Products

Proposed RuleDateFR Citation
Proposed Rule: Miscellaneous combinations8/12/198853FR30522disclaimer icon
   Clarification: Includes promethazine HCl combinations11/14/198853FR45774disclaimer icon
Notice: Prohibits OTC marketing of promethazine HCl combinations9/5/198954FR36762disclaimer icon
Reopening of Administrative Record: Promethazine HCl combinations11/28/198954FR48914disclaimer icon
   Correction1/4/199055FR310disclaimer icon
  Extension of Comment Period1/24/199055FR2387disclaimer icon
Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph7/13/200570FR40232disclaimer icon

Expectorant Drug Products: Pediatric Use

Proposed RuleDateFR Citation
Notice: Advisory Committee Meeting8/16/200772FR46091disclaimer icon
Amendment of Notice: Advisory Committee Meeting10/1/200772FR55784disclaimer icon
Notice of Public Hearing: Request for comments8/25/200873FR50033disclaimer icon
Notice of Public Hearing: Correction9/2/200873FR51309disclaimer icon