21 CFR part 343 ): Internal Analgesic, Antipyretic, Antirheumatic Drug Products for Over-the-Counter Human Use
OTC Internal Analgesic Drug Products found on this page:
Advance Notice Of Proposed Rulemaking
Date
FR CitationAdvance Notice of Proposed Rulemaking
7/8/1977
42FR35346 Extension of Comment Period
10/4/1977
42FR53980 Extension of Comment Period
1/6/1978
43FR1100 Reopening of Administrative Record
3/21/1980
45FR18401 Proposed Rule
Date
FR CitationTentative Final Monograph
11/16/1988
53FR46204 Correction
2/3/1989
54FR5576 Extension of Comment Period
1/16/1990
55FR1471 Notice: Advisory Committee meeting on indications
7/11/1994
59FR35375 Request for Comments
7/22/1994
59FR37421 Notice: Amendment of Advisory Committee meeting agenda
8/16/1994
59FR42060 Notice: Allows marketing of antacid and acetaminophen combinations
2/5/1992
57FR4456 Correction
2/20/1992
57FR6165 Correction
2/28/1992
57FR6892 Final Rule
Date
FR CitationNotice: Withdraws 4/5/1967 Proposed Rule (withdraws obsolete proposed rules)
6/5/1984
49FR23194 Final Rule: Classifies atropine and ephedrine ingredients as nonmonograph
8/24/1998
63FR44996
Proposed Rule
Date
FR CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph
8/25/1992
57FR38568 Correction
9/8/1992
57FR40944 Correction
11/9/1992
57FR53300 Final Rule
Date
FR CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
5/10/1993
58FR27636 Technical Amendment: Correct an ingredient name
10/1/1992
57FR45295
Proposed Rule
Date
FR CitationProposed Rule: Adds ibuprofen as GRASE active ingredient
8/21/2002
67FR54139 Reopening of Comment Period
6/4/2003
68FR33429
Proposed Rule
Date
FR CitationProposed Rule: Aspirin professional labeling (suspected myocardial infarction)
6/13/1996
61FR30002 Final Rule
Date
FR CitationFinal Rule
10/23/1998
63FR56802 Technical Amendment
9/14/1999
64FR49652
Proposed Rule
Date
FR CitationProposed Rule: Prohibits comparative effectiveness claims
4/29/1983
48FR19360 Final Rule
Date
FR CitationFinal Rule: Prohibits comparative effectiveness claims (Bristol Myers)
7/29/1983
48FR34419 Final Rule: Prohibits comparative effectiveness claims (Sterling Drug)
7/29/1983
48FR34424
Proposed Rule
Date
FR CitationNotice: Hearing on NDA withdrawal
8/10/1982
47FR34636 Final Rule
Date
FR CitationNotice: NDA withdrawal
10/5/1983
48FR45466
Proposed Rule
Date
FR Citation Proposed Rule: Requires warning
11/14/1997
62FR61041 Final Rule
Date
FR CitationFinal Rule
10/23/1998
63FR56789 Notice: Extension of compliance date
3/17/1999
64FR13066
Advance Notice Of Proposed Rulemaking
Date
FR CitationAdvance Notice of Proposed Rulemaking
12/28/1982
47FR57886 Correction
1/21/1983
48FR2789 Proposed Rule
Date
FR CitationProposed Rule: Requires warning for aspirin
12/17/1985
50FR51400 Proposed Rule: Makes warning permanent requirement
1/22/1988
53FR1796 Proposed Rule: Requires warning for nonaspirin salicylate-containing drugs
10/20/1993
58FR54228 Final Rule
Date
FR CitationFinal Rule: Requires warning for aspirin
3/7/1986
51FR8180 Final Rule: Makes warning permanent requirement
6/9/1988
53FR21633 Correction
6/30/1988
53FR24830 Final Rule: Requires warning for nonaspirin salicylate-containing drugs
4/17/2003
68FR18861
Proposed Rule
Date
FR CitationProposed Rule: Adds indication
12/24/1991
56FR66762 Proposed Rule: Sodium bicarbonate stomach rupture (overindulgence)
2/2/1994
59FR5068 Reopening of Comment Period
4/19/1994
59FR18507
Proposed Rule
Date
FR CitationProposed Rule: Adds liver and stomach bleeding warnings, removes alcohol warning, and adds additional NSAID labeling
12/26/2006
71FR77314 Final Rule
Date
FR Citation Final Rule: Organ-Specific Warnings and Related Labeling
4/29/2009
74FR19385 Correction
6/30/2009
74FR31177 Technical Amendment
11/25/2009
74FR61512 Notice: Availability of GuidanceGuidance
8/17/2010
75FR50770
Back to Top
Content current as of:
02/04/2020
