Rulemaking History for OTC Nighttime Sleep-Aid Drug Products
Final Monograph (21 CFR part 338)
Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use
OTC Nighttime Sleep-Aid Drug Products found on this page:
Nighttime Sleep-Aid Drug Products: Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 12/8/1975 | 40FR57292--]){kind=small} |
| Correction | 1/8/1976 | 41FR1498 |
| Correction | 1/26/1976 | 41FR3745 |
| Correction | 1/30/1976 | 41FR4600 |
| Reopening of Administrative Record: Category II and III ingredients | 10/26/1979 | 44FR61611 |
| Correction | 11/16/1979 | 44FR65992 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph | 6/13/1978 | 43FR25544 |
| Reopening of Administrative Record | 3/21/1980 | 45FR18399 |
| Final Rule | Date | FR Citation |
| Final Monograph | 2/14/1989 | 54FR6814 |
Nighttime Sleep-Aid Drug Products: Diphenhydramine
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Tentative Final Monograph | 6/13/1978 | 43FR25544 |
| Notice: Allows marketing of diphenhydramine | 4/23/1982 | 47FR17740 |
| Proposed Rule: Revises warnings to be consistent with antihistamines and antitussives | 8/26/1993 | 58FR45217 |
| Proposed Rule: Requires overdose warnings (also antiemetics, antihistamines, and antitussives) | 8/27/1997 | 62FR45767 |
| Final Rule | Date | FR Citation |
| Final Rule: Revises warnings to be consistent with antihistamines and antitussives | 4/11/1994 | 59FR16982 |
| Final Rule: Requires overdose warnings (also antiemetics, antihistamines, and antitussives) | 12/6/2002 | 67FR72555 |