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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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46 rows where docket_id = "FDA-1981-N-0042" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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 Oral Health Care Drug Product; Oral Antiseptic Drug Products 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);