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withdrawn,object_id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-0042-0051,FDA,FDA-1981-N-0042,"Petition Denial Letter from FDA ORA to Olsson Frank & Weeda, PC",Other,Denial,2016-09-13T04:00:00Z,2016,9,2016-09-13T04:00:00Z,,2016-09-13T16:38:25Z,,0,0,09000064805af2b3
FDA-1981-N-0042-0048,FDA,FDA-1981-N-0042,"Attachment 2 Memo to DDM re: Correction from Schering-Plough HealthCare Products (Sinofresh Research Labs, LLC)",Supporting & Related Material,Background Material,2016-09-13T04:00:00Z,2016,9,,,2016-09-13T16:06:35Z,,0,0,09000064822052e2
FDA-1981-N-0042-0043,FDA,FDA-1981-N-0042,"Acknowledgment Letter from FDA DDM to Olsson, Frank, & Weeda, LLC",Other,Acknowledgement Letter/Receipt,2016-09-13T04:00:00Z,2016,9,2016-09-13T04:00:00Z,,2016-09-13T14:00:19Z,,0,0,09000064805af2ad
FDA-1981-N-0042-0044,FDA,FDA-1981-N-0042,"Supplement from Olsson, Frank, & Weeda, P.C. (Sinofresh Research Labs, LLC)",Supporting & Related Material,Background Material,2016-09-13T04:00:00Z,2016,9,,,2016-09-13T14:10:28Z,,0,0,09000064805af2ae
FDA-1981-N-0042-0047,FDA,FDA-1981-N-0042,"Attachment 1 Sinofresh Company Information re: Correction from Schering-Plough HealthCare Products (Sinofresh Research Labs, LLC)",Supporting & Related Material,Background Material,2016-09-13T04:00:00Z,2016,9,,,2016-09-13T16:00:56Z,,0,0,09000064822052e1
FDA-1981-N-0042-0050,FDA,FDA-1981-N-0042,"Attachment 4 Examples of Radio Advertisement re: Correction from Schering-Plough HealthCare Products (Sinofresh Research Labs, LLC)",Supporting & Related Material,Background Material,2016-09-13T04:00:00Z,2016,9,,,2016-09-13T16:26:31Z,,0,0,09000064822052e4
FDA-1981-N-0042-0046,FDA,FDA-1981-N-0042,"Correction from Schering-Plough HealthCare Products (Sinofresh Research Labs, LLC)",Other,Correction(s),2016-09-13T04:00:00Z,2016,9,2016-09-13T04:00:00Z,,2016-09-13T15:56:00Z,,0,0,09000064805af2b2
FDA-1981-N-0042-0049,FDA,FDA-1981-N-0042,"Attachment 3 Product Information on Sinofresh re: Correction from Schering-Plough HealthCare Products (Sinofresh Research Labs, LLC)",Supporting & Related Material,Background Material,2016-09-13T04:00:00Z,2016,9,,,2016-09-13T16:23:10Z,,0,0,09000064822052e3
FDA-1981-N-0042-0040,FDA,FDA-1981-N-0042,"List of References re: Citizen Petition from Olsson, Frank, and Weeda, P.C. (Sinofresh Research Labs, LLC)",Supporting & Related Material,Background Material,2016-09-12T04:00:00Z,2016,9,,,2016-09-12T17:32:36Z,,0,0,09000064805af2a3
FDA-1981-N-0042-0042,FDA,FDA-1981-N-0042,"Attachment 10 Weaver, A. et al. Mouthwash and oral cancer: carcinogen or coincidence? J. Oral Surg. 37:250-253, 1979. re: Citizen Petition from Olsson, Frank, and Weeda, P.C. (Sinofresh Research Labs, LLC)",Supporting & Related Material,Background Material,2016-09-12T04:00:00Z,2016,9,,,2016-09-12T19:10:29Z,,0,0,09000064805af2a7
FDA-1981-N-0042-0038,FDA,FDA-1981-N-0042,Letter from FDA CDER to Colgate-Palmolive Company,Other,Letter(s),2016-09-12T04:00:00Z,2016,9,2016-09-12T04:00:00Z,,2016-09-12T16:52:37Z,,0,0,09000064805af298
FDA-1981-N-0042-0037,FDA,FDA-1981-N-0042,Supplement from SmithKline Beecham Consumer Healthcare,Supporting & Related Material,Background Material,2016-09-12T04:00:00Z,2016,9,,,2016-09-12T16:10:20Z,,0,0,09000064805af296
FDA-1981-N-0042-0041,FDA,FDA-1981-N-0042,"Attachment 9 Robinson, R.F. The effect of quaternary ammonium compounds on oral bacteria: An in vivo study using cetylpyridinium chloride.  J. Dent. Ass. S. Afr. 25:68-74, 1970. re: Citizen Petition from Olsson, Frank, and Weeda, P.C. (Sinofresh Research Labs, LLC)",Supporting & Related Material,Background Material,2016-09-12T04:00:00Z,2016,9,,,2016-09-12T19:05:15Z,,0,0,09000064805af2aa
FDA-1981-N-0042-0039,FDA,FDA-1981-N-0042,"Citizen Petition from Olsson, Frank, and Weeda, P.C. (Sinofresh Research Labs, LLC)",Other,Citizen Petition,2016-09-12T04:00:00Z,2016,9,2016-09-12T04:00:00Z,,2016-09-14T01:01:20Z,,0,0,09000064805af2a2
FDA-1981-N-0042-0031,FDA,FDA-1981-N-0042,Supplement from Procter & Gamble Company,Supporting & Related Material,Background Material,2016-09-06T04:00:00Z,2016,9,,,2016-09-06T15:37:46Z,,0,0,09000064805af291
FDA-1981-N-0042-0035,FDA,FDA-1981-N-0042,Report from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2016-09-06T04:00:00Z,2016,9,,,2016-09-06T18:27:50Z,,0,0,09000064805af299
FDA-1981-N-0042-0034,FDA,FDA-1981-N-0042,Memorandum of Meeting Minutes,Other,Minutes,2016-09-06T04:00:00Z,2016,9,2016-09-06T04:00:00Z,,2016-09-06T16:35:45Z,,0,0,09000064805af29a
FDA-1981-N-0042-0033,FDA,FDA-1981-N-0042,"Protocol Study ""Peroxyl Rinse Study 00194: Microbiological Testing"" from Colgate-Palmolive Company",Other,Protocol Review,2016-09-06T04:00:00Z,2016,9,2016-09-06T04:00:00Z,,2016-09-06T16:19:22Z,,0,0,09000064805af297
FDA-1981-N-0042-0032,FDA,FDA-1981-N-0042,Request for Meeting from Colgate-Palmolive Company,Other,Request,2016-09-06T04:00:00Z,2016,9,2016-09-06T04:00:00Z,,2016-09-06T15:51:50Z,,0,0,09000064805af294
FDA-1981-N-0042-0025,FDA,FDA-1981-N-0042,Attachments XXXI - XXXII Articles from FDA re: Comment from Warner-Lambert Company,Supporting & Related Material,Background Material,2016-09-02T04:00:00Z,2016,9,,,2016-09-02T16:18:17Z,,0,0,09000064821c388c
FDA-1981-N-0042-0027,FDA,FDA-1981-N-0042,"Attachment XXXIX Minah et al Effects of 6 Months Use of an Antiseptic Mouthrinse on Supragingival Dental plaque Microflora. J. Clin. Periodontol; 16: 347-352, 1990. re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-09-02T04:00:00Z,2016,9,,,2016-09-02T16:40:07Z,,0,0,09000064821c38e7
FDA-1981-N-0042-0028,FDA,FDA-1981-N-0042,"Attachment XLIV Warner-Lambert Company Presentation on Alcohol to Dental Products Plaque Subcommittee June 28, 1994. re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-09-02T04:00:00Z,2016,9,,,2016-09-02T16:48:57Z,,0,0,09000064821c38e9
FDA-1981-N-0042-0022,FDA,FDA-1981-N-0042,"Attachment XXIV Pianotti and Pitts Effects of an Antiseptic Mouthwash on Odorigenic Microbes in the Human Gingival Crevice J. Dent. Res., Vol 57: 175-179 February 1978.  re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-09-02T04:00:00Z,2016,9,,,2016-09-02T15:36:50Z,,0,0,09000064821bea4c
FDA-1981-N-0042-0024,FDA,FDA-1981-N-0042,Attachment XXIX - XXX Cited References re: Comment from Warner-Lambert Company,Supporting & Related Material,Background Material,2016-09-02T04:00:00Z,2016,9,,,2016-09-02T16:05:09Z,,0,0,09000064821bea50
FDA-1981-N-0042-0021,FDA,FDA-1981-N-0042,Attachment XXII Letter from Covington & Burling to FDA CDER re: Comment from Warner-Lambert Company,Supporting & Related Material,Background Material,2016-09-02T04:00:00Z,2016,9,,,2016-09-02T15:26:23Z,,0,0,09000064821be97e
FDA-1981-N-0042-0023,FDA,FDA-1981-N-0042,"Attachment XXVI Pianotti and Pitts Effects of an Antispetic Mouthwash on Odorigenic Microbes in the Human Gingival Crevice. J. dent Res., Vol 57: 175-179 February 1978. re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-09-02T04:00:00Z,2016,9,,,2016-09-02T15:50:08Z,,0,0,09000064821bea4e
FDA-1981-N-0042-0026,FDA,FDA-1981-N-0042,Attachment XXXVII Overholser et al Comparative Effects of 2 Chemotherapeutic Mouthrinses on the Development of Supragingival Dental Plaque and Gingivitis. J. Clin Periodontol; 17: 575-579 September 1990. re: Comment from Warner-Lambert Company,Supporting & Related Material,Background Material,2016-09-02T04:00:00Z,2016,9,,,2016-09-02T16:33:01Z,,0,0,09000064821c388f
FDA-1981-N-0042-0029,FDA,FDA-1981-N-0042,"Attachment XLV Mouthwash Use and Oropharyngeal Cancer, Presentation by Dr. Samuel Shapiro to Dental Products Plaque Subcommittee June 28, 1994 re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-09-02T04:00:00Z,2016,9,,,2016-09-02T16:54:17Z,,0,0,09000064821c38ea
FDA-1981-N-0042-0020,FDA,FDA-1981-N-0042,"Attachment XV Slade, H.D. The Anti-Streptococcal Activity of Listerine. Warner-Lambert Research Institute Report. August 1961. re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-08-31T04:00:00Z,2016,8,,,2016-08-31T13:05:31Z,,0,0,09000064821b274f
FDA-1981-N-0042-0019,FDA,FDA-1981-N-0042,"Attachment XIV Reddish, G.F. In Vivo Bacterial Reductions Following the Use of Various Oral Hygiene Products. December 3, 1951 re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-08-31T04:00:00Z,2016,8,,,2016-08-31T12:59:37Z,,0,0,09000064821b274e
FDA-1981-N-0042-0013,FDA,FDA-1981-N-0042,List of Attachments re: Comment from Warner-Lambert Company,Supporting & Related Material,Background Material,2016-08-30T04:00:00Z,2016,8,,,2016-08-30T18:30:42Z,,0,0,09000064821a157f
FDA-1981-N-0042-0014,FDA,FDA-1981-N-0042,"Attachment VII Fine, D.H. et al Reducing Bacteria in Dental Aerosols: Pre-Procedural Use of an Antiseptic Mouthrinse. JADA: Vol. 124, May 1993. re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-08-30T04:00:00Z,2016,8,,,2016-08-30T18:46:52Z,,0,0,09000064821b25d5
FDA-1981-N-0042-0017,FDA,FDA-1981-N-0042,"Attachment XI Campbell, W.C. Listerine's Effectiveness in Reducing Oral Bacterial Counts. October 4, 1932 re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-08-30T04:00:00Z,2016,8,,,2016-08-30T19:03:02Z,,0,0,09000064821b274b
FDA-1981-N-0042-0015,FDA,FDA-1981-N-0042,"Attachment IX Fine, D., et al Reduction of Viable Bacteria in Dental Aerosols by Preprocedural Rinsing with an Antiseptic Mouthrinse. AJD, Vol. 6, October 1993, re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-08-30T04:00:00Z,2016,8,,,2016-08-30T18:56:12Z,,0,0,09000064821b2749
FDA-1981-N-0042-0018,FDA,FDA-1981-N-0042,"Attachment XIII Reddish, G.F. Bacterial Reductions in the Oral Cavity and the Throat. 1941 re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-08-30T04:00:00Z,2016,8,,,2016-08-30T19:13:26Z,,0,0,09000064821b274d
FDA-1981-N-0042-0016,FDA,FDA-1981-N-0042,"Attachment X Hunter, O.B. The In Vitro Germicidal Properties of Listerine. 1932. re: Comment from Warner-Lambert Company",Supporting & Related Material,Background Material,2016-08-30T04:00:00Z,2016,8,,,2016-08-30T18:59:21Z,,0,0,09000064821b274a
FDA-1981-N-0042-0010,FDA,FDA-1981-N-0042,FDA. 1982. Oral health care drug products for over-the-counter human use; proposed rules for oral antiseptic drug products. 47 FR 22760 at 22890-91. re: Comment from Procter & Gamble Company,Supporting & Related Material,Background Material,2016-08-26T04:00:00Z,2016,8,,,2016-08-26T15:23:15Z,,0,0,09000064805af28d
FDA-1981-N-0042-0011,FDA,FDA-1981-N-0042,"Lumpkin, M.M. 1993. Microbiology labeling information letter to NDA holders, Division of
Anti-Infective Drug Products, Center for Drug Evaluation and Research. re: Comment from Procter & Gamble Company",Supporting & Related Material,Background Material,2016-08-26T04:00:00Z,2016,8,,,2016-08-26T15:55:27Z,,0,0,09000064821a0a19
FDA-1981-N-0042-0009,FDA,FDA-1981-N-0042,List of References re: Comment from Procter & Gamble Company,Supporting & Related Material,Background Material,2016-08-26T04:00:00Z,2016,8,,,2016-08-26T14:48:12Z,,0,0,090000648219fcd5
FDA-1981-N-0042-0002,FDA,FDA-1981-N-0042,Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-08-25T04:00:00Z,2016,8,1994-02-09T05:00:00Z,1994-08-09T03:59:59Z,2016-09-17T18:58:24Z,94-2262,0,0,09000064805af28a
FDA-1981-N-0042-0006,FDA,FDA-1981-N-0042,Reference 4 Memorandum of Telephone Conversation re: Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products,Supporting & Related Material,Background Material,2016-08-25T04:00:00Z,2016,8,,,2016-08-25T19:52:17Z,,0,0,090000648219de77
FDA-1981-N-0042-0007,FDA,FDA-1981-N-0042,Reference 5 Adverse Reaction Printouts re: Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products,Supporting & Related Material,Background Material,2016-08-25T04:00:00Z,2016,8,,,2016-08-25T20:08:41Z,,0,0,090000648219de78
FDA-1981-N-0042-0003,FDA,FDA-1981-N-0042,"Published Federal Register Notice 59FR6084 ""Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products""",Supporting & Related Material,Background Material,2016-08-25T04:00:00Z,2016,8,,,2016-08-25T16:54:47Z,,0,0,09000064805af2b0
FDA-1981-N-0042-0004,FDA,FDA-1981-N-0042,Table of Contents References re: Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products,Supporting & Related Material,Background Material,2016-08-25T04:00:00Z,2016,8,,,2016-08-25T16:59:17Z,,0,0,090000648219cfa8
FDA-1981-N-0042-0005,FDA,FDA-1981-N-0042,Reference 3 Memorandum of Meeting re: Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products,Supporting & Related Material,Background Material,2016-08-25T04:00:00Z,2016,8,,,2016-08-25T19:48:25Z,,0,0,090000648219de76
FDA-1981-N-0042-0001,FDA,FDA-1981-N-0042,"Interim Response Letter from FDA CDER to Olsson, Frank & Weeda, PC",Other,Letter(s),2003-10-24T04:00:00Z,2003,10,,,2016-09-13T15:01:14Z,,0,0,09000064805af285