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 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History for OTC Expectorant Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Expectorant Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 341)**:***Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use*FDA Archive-It webpage: Rulemaking History for OTC Expectorant Drug ProductsSearch for Federal Register documents:GPO Federal Register Database (1994 to present)HeinOnline provides online access to Federal Registers from 1936-forwardOTC Expectorant Drug Products found on this page:Original Active Ingredients and LabelingCombination ProductsPediatric Use**Expectorant Drug Products: Original Active Ingredients and Labeling**Advance Notice Of Proposed RulemakingDate*FR* CitationAdvance Notice of Proposed Rulemaking9/9/197641FR38312Reopening of Administrative Record3/21/198045FR18400Reopening of Administrative Record9/26/198045FR63874Proposed RuleDate*FR* CitationTentative Final Monograph7/9/198247FR30002Extension of Comment Period8/27/198247FR37934Final RuleDate*FR* CitationFinal Monograph2/28/198954FR8494Correction3/22/198954FR11866Technical Amendment: Replaces "sputum" with "mucus" in indication6/30/199257FR29176Final Rule: Classifies ipecac as nonmonograph9/14/199257FR41857Correction10/6/199257FR46067**Expectorant Drug Products: Combination Products**Proposed RuleDate*FR* CitationProposed Rule: Miscellaneous combinations8/12/198853FR30522Clarification: Includes promethazine HCl combinations11/14/198853FR45774Notice: Prohibits OTC marketing of promethazine HCl combinations9/5/198954FR36762Reopening of Administrative Record: Promethazine HCl combinations11/28/198954FR48914disclaimer iconCorrection1/4/199055FR310Extension of Comment Period1/24/199055FR2387Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph7/13/200570FR40232**Expectorant Drug Products: Pediatric Use**Proposed RuleDate*FR* CitationNotice: Advisory Committee Meeting8/16/200772FR46091Amendment of Notice: Advisory Committee Meeting10/1/200772FR55784Notice of Public Hearing: Request for comments8/25/200873FR50033Notice of Public Hearing: Correction9/2/200873FR51309

                                                                                  Content current as of:
      05/31/2017Historical Status of OTC Rulemakings
 
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