Rulemaking History for OTC Antitussive Drug Products
Final Monograph (21 CFR part 341):
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
OTC Antitussive Drug Products found on this page:
- Original Active Ingredients and Labeling
- Benylin
- Camphor and Menthol
- Combination Products
- Dextromethorphan
- Diphenhydramine HCl and Citrate
- Menthol Lozenge
- Pediatric Use
- Phenylpropanolamine (PPA)
Antitussive Drug Products: Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 9/9/1976 | 41FR38312 |
| Reopening of Administrative Record [PDF] | 3/21/1980 | 45FR18400 |
| Reopening of Administrative Record: Camphor-containing products [PDF] | 9/26/1980 | 45FR63874 |
| Notice: Advisory Committee meeting [PDF] | 4/29/1983 | 48FR19470 |
| Notice: Republication of 4/29/1983 notice [PDF] | 5/6/1983 | 48FR20502 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 10/19/1983 | 48FR48576 |
| Correction [PDF] | 11/16/1983 | 48FR52079 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 8/12/1987 | 52FR30042 |
| Correction [PDF] | 9/9/1987 | 52FR34047 |
| Correction [PDF] | 9/22/1987 | 52FR35610 |
| Technical Amendment: Clarifies age range for children's dosage [PDF] | 9/15/1988 | 53FR35808 |
| Technical Amendment: Removes carbetapentane citrate from 21CFR310.201(a)(20) [PDF] | 11/30/2007 | 72FR67639 |
Antitussive Drug Products: Benylin
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Notice: Hearing on unapproved NDA [PDF] | 11/30/1976 | 41FR52537 |
| Final Rule | Date | FR Citation |
| Final Decision [PDF] | 8/31/1979 | 44FR51512 |
| Correction [PDF] | 10/2/1979 | 44FR56744 |
Antitussive Drug Products: Camphor and Menthol
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Revises warning and directions for topical/inhalant products [PDF] | 7/20/1998 | 63FR38762 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 8/1/2000 | 65FR46864 |
Antitussive Drug Products: Combination Products
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule [PDF] | 8/12/1988 | 53FR30522 |
| Clarification: Promethazine HCl combinations [PDF] | 11/14/1988 | 53FR45774 |
| Notice: Bans interim marketing of promethazine HCl combinations [PDF] | 9/5/1989 | 54FR36762 |
| Reopening of Administrative Record: Promethazine HCl combinations [PDF] | 11/28/1989 | 54FR48914 |
| Correction [PDF] | 1/4/1990 | 55FR310 |
| Extension of Comment Period [PDF] | 1/24/1990 | 55FR2387 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 12/23/2002 | 67FR78158 |
| Technical Amendment: Correction [PDF] | 3/19/2007 | 72FR12730 |
Antitussive Drug Products: Dextromethorphan
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Monoamine oxidase inhibitor (MAOI) warning [PDF] | 6/19/1992 | 57FR27666 |
| Extension of Comment Period [PDF] | 8/6/1992 | 57FR34735 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 10/20/1993 | 58FR54232 |
| Notice: Advisory Committee Meeting | 5/4/2010 | 75FR23782 |
Antitussive Drug Products: Diphenhydramine HCl and Citrate
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Adds diphenhydramine HCl & diphenhydramine citrate as GRASE ingredients [PDF] | 12/9/1992 | 57FR58378 |
| Proposed Rule: Classifies diphenhydramine combinations as GRASE or nonmonograph [PDF] | 2/23/1995 | 60FR10286 |
| Proposed Rule: Requires warnings on all diphenhydramine products [PDF] | 8/29/1997 | 62FR45767 |
| Final Rule | Date | FR Citation |
| Final Rule: Adds diphenhydramine HCl & diphenhydramine citrate as GRASE ingredients [PDF] | 6/3/1994 | 59FR29172 |
| Correction [PDF] | 7/15/1994 | 59FR36051 |
| Final Rule: Allows interim marketing of combinations [PDF] | 4/9/1996 | 61FR15700 |
| Final Rule: Requires warnings on all diphenhydramine products [PDF] | 12/6/2002 | 67FR72555 |
Antitussive Drug Products: Menthol Lozenge
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Exempts "accidental overdose" warning [PDF] | 7/6/1989 | 54FR28442 |
| Proposed Rule: Allows and defines "lozenge" as solid dose [PDF] | 10/2/1989 | 54FR40412 |
| Final Rule | Date | FR Citation |
| Final Rule: Exempts "accidental overdose" warning [PDF] | 7/6/1990 | 55FR27806 |
| Final Rule: Allows and defines "lozenge" as solid dose [PDF] | 10/3/1990 | 55FR40381 |
Antitussive Drug Products: Pediatric Use
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Notice: Advisory Committee Meeting [PDF] | 8/16/2007 | 72FR46091 |
| Amendment of Notice: Advisory Committee Meeting [PDF] | 10/1/2007 | 72FR55784 |
| Notice of Public Hearing: Request for comments [PDF] | 8/25/2008 | 73FR50033 |
| Notice of Public Hearing: Correction [PDF] | 9/2/2008 | 73FR51309 |
Antitussive Drug Products: Phenylpropanolamine (PPA)
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Clarifies dosage [PDF] | 10/28/1977 | 42FR56756 |
| Notice: Advisory Committee meeting [PDF] | 8/30/2000 | 65FR52775 |
| Notice: Hearing on NDA withdrawal [PDF] | 8/14/2001 | 66FR42665 |