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withdrawn,object_id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-2021-N-0862-0237,FDA,FDA-2021-N-0862,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2025-09-25T04:00:00Z,2025,9,,,2025-09-25T18:07:52Z,2025-18621,0,0,09000064b8fdca45
FDA-2021-N-0862-0236,FDA,FDA-2021-N-0862,Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Rule,Final Rule,2025-03-25T04:00:00Z,2025,3,,,2025-03-25T14:47:53Z,2025-04978,0,0,0900006486a2a7ed
FDA-2021-N-0862-0235,FDA,FDA-2021-N-0862,Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Rule,Final Rule,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T14:30:42Z,2025-01840,0,0,0900006486900454
FDA-2021-N-0862-0228,FDA,FDA-2021-N-0862,Memorandum re Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Final Rule),Other,Memo,2025-01-23T05:00:00Z,2025,1,2025-01-23T05:00:00Z,,2025-01-23T14:51:11Z,,0,0,09000064868c21c5
FDA-2021-N-0862-0229,FDA,FDA-2021-N-0862,TAB A-2023-142-ACNU-Final Rule-Original,Supporting & Related Material,Background Material,2025-01-15T05:00:00Z,2025,1,,,2025-01-15T18:59:12Z,,0,0,09000064868c2151
FDA-2021-N-0862-0234,FDA,FDA-2021-N-0862,TAB C-2023-142-ACNU-FRIA-Final,Supporting & Related Material,Background Material,2025-01-15T05:00:00Z,2025,1,,,2025-01-15T19:11:26Z,,0,0,09000064868c2155
FDA-2021-N-0862-0232,FDA,FDA-2021-N-0862,TAB B-2023-142-ACNU-FRIA-TRACK CHANGE FROM ORIGINAL TO FINAL,Supporting & Related Material,Background Material,2025-01-15T05:00:00Z,2025,1,,,2025-01-15T19:10:30Z,,0,0,09000064868c21cb
FDA-2021-N-0862-0231,FDA,FDA-2021-N-0862,TAB B-2023-142-ACNU-Final Rule-TRACK CHANGE FROM ORIGINAL TO FINAL,Supporting & Related Material,Background Material,2025-01-15T05:00:00Z,2025,1,,,2025-01-15T19:04:00Z,,0,0,09000064868c2153
FDA-2021-N-0862-0230,FDA,FDA-2021-N-0862,TAB A-2023-142-ACNU-FRIA-Original,Supporting & Related Material,Background Material,2025-01-15T05:00:00Z,2025,1,,,2025-01-15T19:02:02Z,,0,0,09000064868c2152
FDA-2021-N-0862-0233,FDA,FDA-2021-N-0862,TAB C-2023-142-ACNU-Final Rule-Final,Supporting & Related Material,Background Material,2025-01-15T05:00:00Z,2025,1,,,2025-01-15T19:08:03Z,,0,0,09000064868c2154
FDA-2021-N-0862-0219,FDA,FDA-2021-N-0862,Reference 10 - FDA Combination Products web page,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2025-02-23T18:35:38Z,,0,0,090000648688c405
FDA-2021-N-0862-0226,FDA,FDA-2021-N-0862,Reference 18 - 73 FR 63491_Docket FDA-2008-N-0549_10-24-2008,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T20:00:49Z,,0,0,090000648688c497
FDA-2021-N-0862-0227,FDA,FDA-2021-N-0862,Reference 19 - 83 FR 40973_Docket FDA-2017-N-6730_08-17-2018,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T20:00:54Z,,0,0,090000648688c4a8
FDA-2021-N-0862-0215,FDA,FDA-2021-N-0862,Reference 7a - NPSA_Guide to Graphic Design of Medication Packaging 2nd Ed_2007,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T19:59:19Z,,0,0,090000648688c3cb
FDA-2021-N-0862-0218,FDA,FDA-2021-N-0862,Reference 9 - FDA eCTD Resources web page,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2025-02-23T18:35:38Z,,0,0,090000648688c403
FDA-2021-N-0862-0223,FDA,FDA-2021-N-0862,Reference 15 - 83 FR 13394_Docket FDA-2008-N-0549_04-02-2018,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T20:00:19Z,,0,0,090000648688c490
FDA-2021-N-0862-0225,FDA,FDA-2021-N-0862,Reference 17 - 87 FR 68702_Docket FDA-2022-N-2673_11-16-2022,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T20:00:41Z,,0,0,090000648688c493
FDA-2021-N-0862-0220,FDA,FDA-2021-N-0862,Reference 11 - MOU Between the FTC and FDA Concerning the Exchange of Information (FDA-225-71-8003)_April 1971,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T19:59:53Z,,0,0,090000648688c406
FDA-2021-N-0862-0217,FDA,FDA-2021-N-0862,Reference 8 - USP_Recommendations to the Safe Medication Use Expert Committee by the Health Literacy and Prescription Container Labeling Advisory Panel_2010,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T19:59:32Z,,0,0,090000648688c402
FDA-2021-N-0862-0208,FDA,FDA-2021-N-0862,Reference List - Nonprescription Drug Product With an Additional Condition for Nonprescription Use - Final Rule,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T19:58:28Z,,0,0,090000648688c868
FDA-2021-N-0862-0207,FDA,FDA-2021-N-0862,Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Rule,Final Rule,2024-12-26T05:00:00Z,2024,12,2024-12-26T05:00:00Z,,2024-12-26T15:41:32Z,2024-30261,0,0,090000648688bfbc
FDA-2021-N-0862-0216,FDA,FDA-2021-N-0862,Reference 7b - NPSA_Guide to Labelling and Packaging of Injectable Medicines_1st Ed_2007,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T19:59:23Z,,0,0,090000648688c3cc
FDA-2021-N-0862-0209,FDA,FDA-2021-N-0862,Reference 1 - FDA Guidance for Industry_Label -Comprehension-Studies-for-Nonprescription-Drug-Products_Aug2010,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T19:58:33Z,,0,0,090000648688c8ae
FDA-2021-N-0862-0212,FDA,FDA-2021-N-0862,Reference 4 - FDA Guidance for Industry and FDA Staff_Policy for Device Software Functions and Mobile Medical Applications,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T19:58:49Z,,0,0,090000648688c8b3
FDA-2021-N-0862-0213,FDA,FDA-2021-N-0862,Reference 5 - FDA Medwatch The FDA Safety Information and Adverse Event Reporting Program,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2025-02-23T18:35:38Z,,0,0,090000648688c3c7
FDA-2021-N-0862-0221,FDA,FDA-2021-N-0862,Reference 12 - FDA Prescription to Over-the-Counter (OTC) Switch List web page,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2025-02-23T18:35:37Z,,0,0,090000648688c407
FDA-2021-N-0862-0211,FDA,FDA-2021-N-0862,Reference 3 - FDA Guidance for Industry_Application of Human Factors Engineering Principles for Combination Products QA_Sept2023,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T19:58:45Z,,0,0,090000648688c8b1
FDA-2021-N-0862-0222,FDA,FDA-2021-N-0862,Reference 14 - 87 FR 38313_Docket FDA-2021-N-0862_06-28-2022,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T20:00:08Z,,0,0,090000648688c986
FDA-2021-N-0862-0224,FDA,FDA-2021-N-0862,Reference 16 - 70 FR 52050_Docket 2005N-0345_09-01-2005,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T20:00:32Z,,0,0,090000648688c491
FDA-2021-N-0862-0210,FDA,FDA-2021-N-0862,Reference 2 - FDA Guidance for Industry_Self-Selection-Studies-for-Nonprescription-Drug-Products_April2013,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2024-12-26T19:58:41Z,,0,0,090000648688c8b0
FDA-2021-N-0862-0214,FDA,FDA-2021-N-0862,Reference 6 - FDA Consumer Complaint Coordinators web page,Supporting & Related Material,Background Material,2024-12-26T05:00:00Z,2024,12,,,2025-02-23T18:35:38Z,,0,0,090000648688c3c8
FDA-2021-N-0862-0206,FDA,FDA-2021-N-0862,"TAB C-NSURE-ProposedRule-Final RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022",Supporting & Related Material,Background Material,2023-01-20T05:00:00Z,2023,1,,,2023-01-20T20:02:50Z,,0,0,09000064855fd2fe
FDA-2021-N-0862-0203,FDA,FDA-2021-N-0862,"TAB B-2017-723-NSURERULE-TRACK CHANGE FROM ORIGINAL TO FINAL RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022",Supporting & Related Material,Background Material,2023-01-20T05:00:00Z,2023,1,,,2023-01-20T20:02:31Z,,0,0,09000064855fd148
FDA-2021-N-0862-0201,FDA,FDA-2021-N-0862,"TAB A-2017-723-NSURE-PRIA RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022",Supporting & Related Material,Background Material,2023-01-20T05:00:00Z,2023,1,,,2023-01-20T20:02:18Z,,0,0,09000064855fd2fb
FDA-2021-N-0862-0204,FDA,FDA-2021-N-0862,"TAB B-NSURE-PRIA-TRACK CHANGE FROM ORIGINAL TO FINAL RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022",Supporting & Related Material,Background Material,2023-01-20T05:00:00Z,2023,1,,,2023-01-20T20:02:37Z,,0,0,09000064855fd149
FDA-2021-N-0862-0205,FDA,FDA-2021-N-0862,"TAB C-NSURE-PRIA-Final RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022",Supporting & Related Material,Background Material,2023-01-20T05:00:00Z,2023,1,,,2023-01-20T20:02:44Z,,0,0,09000064855fd2fd
FDA-2021-N-0862-0200,FDA,FDA-2021-N-0862,"Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022",Other,Memorandum,2023-01-20T05:00:00Z,2023,1,2023-01-20T05:00:00Z,,2023-01-20T20:01:00Z,,0,0,09000064855fd0c5
FDA-2021-N-0862-0202,FDA,FDA-2021-N-0862,"TAB A-2017-723-NSURERULE RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022",Supporting & Related Material,Background Material,2023-01-20T05:00:00Z,2023,1,,,2023-01-20T20:02:25Z,,0,0,09000064855fd147
FDA-2021-N-0862-0177,FDA,FDA-2021-N-0862,FDA Listening Session with APhA Stakeholders--High-Level Notes,Other,Meeting Exhibits,2022-11-22T05:00:00Z,2022,11,2022-11-22T05:00:00Z,2022-11-26T04:59:59Z,2022-11-22T20:15:53Z,,0,0,09000064854fc3fd
FDA-2021-N-0862-0140,FDA,FDA-2021-N-0862,Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Extension of Comment Period,Proposed Rule,Extension of Comment Period,2022-10-24T04:00:00Z,2022,10,2022-10-24T04:00:00Z,,2022-11-22T18:58:05Z,2022-23033,0,0,090000648544cb97
FDA-2021-N-0862-0043,FDA,FDA-2021-N-0862,Request for Extension from Consumer Healthcare Products Association,Other,Request for Extension,2022-10-06T04:00:00Z,2022,10,2022-10-06T04:00:00Z,,2022-11-22T18:57:53Z,,0,0,09000064853bd957
FDA-2021-N-0862-0039,FDA,FDA-2021-N-0862,Request for Extension from American Pharmacists Association,Other,Request for Extension,2022-09-26T04:00:00Z,2022,9,2022-09-26T04:00:00Z,,2022-11-22T18:57:40Z,,0,0,090000648536e90d
FDA-2021-N-0862-0001,FDA,FDA-2021-N-0862,Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2022-06-28T04:00:00Z,2022,6,2022-06-28T04:00:00Z,2022-11-26T04:59:59Z,2024-08-23T01:00:37Z,2022-13309,0,0,09000064851a6c55
FDA-2021-N-0862-0008,FDA,FDA-2021-N-0862,Reference 6- Engelberg Expert Workshop--Exploring Implications of the Nonprescription Drug Safe Use Regulatory Expansion Initiative on Reimbursement and Access_2013  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:48:58Z,,0,0,09000064851a6e08
FDA-2021-N-0862-0011,FDA,FDA-2021-N-0862,Reference 9 - 70 FR 52050  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:46:47Z,,0,0,09000064851a6e05
FDA-2021-N-0862-0004,FDA,FDA-2021-N-0862,Reference 2-  Journal of Research in Pharmacy Practice re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:32:38Z,,0,0,09000064851a6e07
FDA-2021-N-0862-0010,FDA,FDA-2021-N-0862,Reference 8- 83 FR 13394  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:45:35Z,,0,0,09000064851a6e03
FDA-2021-N-0862-0009,FDA,FDA-2021-N-0862,Reference 7- FDA Preliminary Regulatory Impact Analysis_Initial Regulatory Flexibility Analysis Unfunded Mandates Reform Act Analysis  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:43:52Z,,0,0,09000064851a6e04
FDA-2021-N-0862-0005,FDA,FDA-2021-N-0862,Reference 3- Guidance for Industry Label Comprehension Studies for Nonprescription Drug Products  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:34:10Z,,0,0,09000064851a56d6
FDA-2021-N-0862-0007,FDA,FDA-2021-N-0862,Reference 5- Engelberg Expert Workshop--Innovative Technologies and Nonprescription Medications--Addressing Undertreated Diseases and Conditions through Technology Enabled Self-Care  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:39:56Z,,0,0,09000064851a6e0a
FDA-2021-N-0862-0003,FDA,FDA-2021-N-0862,"Reference 1- Guidance for Industry Self-Selection Studies for Nonprescription Drug
Products  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use",Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:30:20Z,,0,0,09000064851a56d8
FDA-2021-N-0862-0013,FDA,FDA-2021-N-0862,Reference 11 - 83 FR 33938  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:49:29Z,,0,0,09000064851a6e02
FDA-2021-N-0862-0002,FDA,FDA-2021-N-0862,Reference List re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:28:40Z,,0,0,09000064851a56d7
FDA-2021-N-0862-0006,FDA,FDA-2021-N-0862,Reference 4- Engleberg Expert Workshop--Nonprescription Medications With Conditions of Safe Use as a Novel Solution for Undertreated Diseases or conditions  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:38:18Z,,0,0,09000064851a6e06
FDA-2021-N-0862-0012,FDA,FDA-2021-N-0862,Reference 10 - 77 FR 12059  re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:49:16Z,,0,0,09000064851a6e09