id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-1981-N-0015-0060,FDA,FDA-1981-N-0015,Supplement from Clinical Clean  Inc. re Additional Data to be Considered Over the Counter Drug Products for the Reduction or Prevention of Dental Plaque and Gingivitis Establishment of a Monograph,Other,Supplement (SUP),2023-04-04T04:00:00Z,2023,4,,,2023-04-04T15:34:00Z,,0,0,09000064805aed38
FDA-1981-N-0015-0067,FDA,FDA-1981-N-0015,"Supplement from WhiteHill Oral Technologies, Inc. re Proposed Antiplaque/Antigingivitis OTC Drug Monograph",Other,Supplement (SUP),2023-04-04T04:00:00Z,2023,4,2023-04-04T04:00:00Z,,2023-04-04T16:11:24Z,,0,0,09000064805aee8c
FDA-1981-N-0015-0056,FDA,FDA-1981-N-0015,"Letter to Morgan, Lewis & Bockius, LLP from FDA CDER",Other,Letter(s),2020-11-02T05:00:00Z,2020,11,2020-11-02T05:00:00Z,,2020-11-02T17:58:16Z,,0,0,090000648494673e
FDA-1981-N-0015-0055,FDA,FDA-1981-N-0015,Withdrawal of Time and Extent Applications (TEAs) from Morgan Lewis (BASF),Other,Withdrawal,2016-08-29T04:00:00Z,2016,8,2016-08-29T04:00:00Z,,2016-08-29T15:04:24Z,,0,0,09000064821a8fe9
FDA-1981-N-0015-0054,FDA,FDA-1981-N-0015,Shipping Label from Ciba Speciality Chemicals Corporation Ciba,Supporting & Related Material,Transmittals,2015-04-27T04:00:00Z,2015,4,,,2015-04-29T20:15:39Z,,0,0,09000064805aee96
FDA-1981-N-0015-0053,FDA,FDA-1981-N-0015,Shipping Label from Ciba Speciality Chemicals Corporation Ciba,Supporting & Related Material,Transmittals,2015-04-21T04:00:00Z,2015,4,,,2015-04-29T20:15:02Z,,0,0,09000064805aed6b
FDA-1981-N-0015-0042,FDA,FDA-1981-N-0015,Withdrawal from Colgate-Palmolive Company to FDA/CDER,Other,Withdrawal,2014-11-19T05:00:00Z,2014,11,2014-11-19T05:00:00Z,,2015-06-12T13:19:37Z,,0,0,0900006481536734
FDA-1981-N-0015-0040,FDA,FDA-1981-N-0015,Citizen Petition from Colgate-Palmolive Company,Other,Citizen Petition,2012-05-18T04:00:00Z,2012,5,2012-05-18T04:00:00Z,,2024-11-12T04:54:26Z,,1,0,09000064810071d9
FDA-1981-N-0015-0041,FDA,FDA-1981-N-0015,Acknowledgement Letter from FDA/CDER to Colgate-Palmolive Company,Other,Acknowledgement Letter/Receipt,2012-05-18T04:00:00Z,2012,5,2012-05-18T04:00:00Z,,2015-04-29T16:09:40Z,,0,0,0900006481007239
FDA-1981-N-0015-0039,FDA,FDA-1981-N-0015,Letter from Consumer Healthcare Products Association (CHPA) re Oral Health Care Drug Products for OTC Human Use,Other,Letter(s),2008-09-29T04:00:00Z,2008,9,2008-09-29T04:00:00Z,,2015-04-29T17:41:20Z,,0,0,0900006480702320
FDA-1981-N-0015-0038,FDA,FDA-1981-N-0015,Letter from FDA CDER to Consumer Healthcare Products Association re 1981N-0033P,Other,Letter(s),2008-08-15T04:00:00Z,2008,8,2008-08-15T04:00:00Z,,2015-04-29T17:35:34Z,,0,0,09000064806a1695
FDA-1981-N-0015-0036,FDA,FDA-1981-N-0015,Letter from FDA/CDER to the Global Oral Care Procter & Gamble Company,Other,Letter(s),2008-08-15T04:00:00Z,2008,8,2008-08-15T04:00:00Z,,2015-04-29T17:28:03Z,,0,0,09000064806a1584
FDA-1981-N-0015-0037,FDA,FDA-1981-N-0015,Letter from FDA CDER to Combe Incorporated re Stephen Pennisi,Other,Letter(s),2008-08-15T04:00:00Z,2008,8,2008-08-15T04:00:00Z,,2015-04-29T17:36:29Z,,0,0,09000064806a1623
FDA-1981-N-0015-0033,FDA,FDA-1981-N-0015,Comment from HFD-560 to Colgate-Palmolive Company,Other,Answer,2005-04-18T04:00:00Z,2005,4,,,2015-04-28T19:47:18Z,,0,0,09000064805aef36
FDA-1981-N-0015-0025,FDA,FDA-1981-N-0015,Background Material from Ciba Speciality Chemicals Corporation USA re Material Time and Extent Data Triclosan TEA,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-29T20:49:49Z,,0,0,09000064805aeea7
FDA-1981-N-0015-0030,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re UK Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-29T20:32:02Z,,0,0,09000064805aeeac
FDA-1981-N-0015-0014,FDA,FDA-1981-N-0015,Background Material from Ciba Specialty Chemicals Corporation USA re Appendix 1 Triclosan Safety Studies Submitted to OTC Docket 81 N-033P,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T13:56:00Z,,0,0,09000064805aee9c
FDA-1981-N-0015-0016,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re Australia Labels Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T14:02:57Z,,0,0,09000064805aee9e
FDA-1981-N-0015-0021,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re Brazil Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T13:25:43Z,,0,0,09000064805aeea3
FDA-1981-N-0015-0031,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re Germany Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-29T20:32:31Z,,0,0,09000064805aeead
FDA-1981-N-0015-0011,FDA,FDA-1981-N-0015,Background Material from FDA/CDER to Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-05-11T16:37:37Z,,0,0,09000064805aee99
FDA-1981-N-0015-0024,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re Italy Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T13:18:52Z,,0,0,09000064805aeea6
FDA-1981-N-0015-0012,FDA,FDA-1981-N-0015,Background Material from FDA/CDER re Time and Extent Application (TEA) Review for Triclosan,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-05-11T16:38:08Z,,0,0,09000064805aee9a
FDA-1981-N-0015-0028,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re France Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-29T20:37:08Z,,0,0,09000064805aeeaa
FDA-1981-N-0015-0015,FDA,FDA-1981-N-0015,Background Material from Ciba Specialty Chemicals Corporation USA re APPENDIX 2 Specifications Analytical Methods USP,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T13:58:55Z,,0,0,09000064805aee9d
FDA-1981-N-0015-0022,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re Canada Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T13:23:37Z,,0,0,09000064805aeea4
FDA-1981-N-0015-0019,FDA,FDA-1981-N-0015,Tab 1 Cumulative Volume of Triclosan Use (Kg/Year) in Oral Care Applications (AntigingivitislAntiplaque) By Geographic Region 1992-2003 re Comment from Ciba Specialty Chemicals Corporation USA,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T13:35:28Z,,0,0,09000064805aeea1
FDA-1981-N-0015-0027,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re India Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-29T20:39:29Z,,0,0,09000064805aeea9
FDA-1981-N-0015-0023,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re Chile Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T13:21:05Z,,0,0,09000064805aeea5
FDA-1981-N-0015-0026,FDA,FDA-1981-N-0015,Background Material from Ciba Speciality Chemicals Corporation USA re Follow-UD to Time and Extent ADDliCatiOD: Inclusion of Triclosan in OTC Monograph for Antigingivitis/Antiplaque Drug Products,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-29T20:43:31Z,,0,0,09000064805aeea8
FDA-1981-N-0015-0017,FDA,FDA-1981-N-0015,"Background Material from Division of OTC Drug Products, HFD-560 re 1981N-033P",Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T14:15:22Z,,0,0,09000064805aee9f
FDA-1981-N-0015-0010,FDA,FDA-1981-N-0015,Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Antigingivitis/Antiplaque Ingredient; Notice of Requesting Data,Notice,"NRD-Notice of Requesting Data, Info, & Views",2004-07-06T04:00:00Z,2004,7,2004-07-02T04:00:00Z,2004-10-05T03:59:59Z,2015-06-09T18:37:54Z,,0,0,09000064805aee98
FDA-1981-N-0015-0018,FDA,FDA-1981-N-0015,"Background Material  from Ciba Specialty Chemicals Corporation USA re Follow-up to Time and Extent Application Inclusion of Triclosan in OTC
Monograph for Antigingivitis/Antiplaque Drug Products (Docket No. 81N-033P)",Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T14:10:59Z,,0,0,09000064805aeea0
FDA-1981-N-0015-0029,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re China Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-29T20:35:00Z,,0,0,09000064805aeeab
FDA-1981-N-0015-0013,FDA,FDA-1981-N-0015,Background Material from Ciba Specialty Chemicals Corporation USA re Time and Extent Application Triclosan USP,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T13:51:54Z,,0,0,09000064805aee9b
FDA-1981-N-0015-0020,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re Africa Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-30T13:29:14Z,,0,0,09000064805aeea2
FDA-1981-N-0015-0032,FDA,FDA-1981-N-0015,Background Material  from Ciba Specialty Chemicals Corporation USA re  Mexico Labels,Supporting & Related Material,Background Material,2004-07-06T04:00:00Z,2004,7,,,2015-04-29T20:24:21Z,,0,0,09000064805aeeae
FDA-1981-N-0015-0009,FDA,FDA-1981-N-0015,Notice of Correction from FDA CDER re Oral Health Care Drug Products for Over the Counter Human Use Antigingivitis Antiplaque Drug Products Establishment of a Monograph Extension of Comment Period Correction,Notice,Correction,2003-10-09T04:00:00Z,2003,10,2003-08-25T04:00:00Z,2003-11-26T04:59:59Z,2015-05-27T16:52:38Z,,0,0,09000064805aed36
FDA-1981-N-0015-0008,FDA,FDA-1981-N-0015,Notice of extension from FDA CDER re Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph; Extension of Comment Period,Notice,Notice of Extension,2003-08-27T04:00:00Z,2003,8,2003-08-25T04:00:00Z,2003-11-26T04:59:59Z,2015-05-27T16:46:12Z,,0,0,09000064805aed33
FDA-1981-N-0015-0005,FDA,FDA-1981-N-0015,Advance Notice of Proposed Rule from FDA/CDER re Oral Health Care Drug Products for Over-the-Counter Human Use Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph,Proposed Rule,Advance Notice of Proposed Rulemaking (ANPRM),2003-06-03T04:00:00Z,2003,6,2003-05-29T04:00:00Z,2003-08-28T03:59:59Z,2015-05-27T15:40:23Z,,0,0,09000064805aed28
FDA-1981-N-0015-0006,FDA,FDA-1981-N-0015,Advance Notice of Proposed Rule from FDA/CDER re Oral Health Care Drug Products for Over-the-Counter Human Use Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph,Proposed Rule,Advance Notice of Proposed Rulemaking (ANPRM),2003-06-03T04:00:00Z,2003,6,2003-05-29T04:00:00Z,2003-08-28T03:59:59Z,2015-05-27T15:42:27Z,,0,0,09000064805aed29
FDA-1981-N-0015-0007,FDA,FDA-1981-N-0015,Advance Notice of Proposed Rulemaking FDA/CDER re Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph,Proposed Rule,Advance Notice of Proposed Rulemaking (ANPRM),2003-06-03T04:00:00Z,2003,6,2003-05-29T04:00:00Z,2003-08-28T03:59:59Z,2015-06-09T18:29:40Z,,0,0,09000064805aed2a
FDA-1981-N-0015-0001,FDA,FDA-1981-N-0015,Over-the-Counter Dental and Oral Health Care Drug Products for Antiplaque Use; Safety and Efficacy Review; Request for Data and Information,Notice,Requests for Information (RFI),1995-05-02T04:00:00Z,1995,5,1995-05-02T04:00:00Z,1991-03-19T04:59:59Z,2023-03-31T12:55:51Z,,0,0,09000064805aecdc
FDA-1981-N-0015-0004,FDA,FDA-1981-N-0015,Notice of Extension from FDA/CDER re over the couter dental and oral health care drug products for antiplaque use safty and efficacy review extension of submission period,Notice,Notice of Extension,1995-05-02T04:00:00Z,1995,5,1995-05-02T04:00:00Z,1991-06-18T03:59:59Z,2015-06-09T18:22:26Z,,0,0,09000064805aecfa
FDA-1981-N-0015-0003,FDA,FDA-1981-N-0015,Notice of Extension from FDA CDER re Over the counter dental and oral health care drug products for antiplaque use safty and efficacy review extension of submission period,Notice,Notice of Extension,1995-05-02T04:00:00Z,1995,5,1995-05-02T04:00:00Z,1991-06-18T03:59:59Z,2015-05-27T16:23:27Z,,0,0,09000064805aecf9
FDA-1981-N-0015-0002,FDA,FDA-1981-N-0015,Over-the-Counter Dental and Oral Health Care Drug Products for Antiplaque Use; Safety and Efficacy Review; Request for Data and Information,Notice,Requests for Information (RFI),1995-05-02T04:00:00Z,1995,5,1995-05-02T04:00:00Z,1991-03-19T04:59:59Z,2023-03-31T12:56:48Z,,0,0,09000064805aece2