documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
23 rows where docket_id = "FDA-2026-P-5454" sorted by posted_date descending
This data as json, CSV (advanced)
Suggested facets: subtype, open_for_comment, posted_date (date), comment_start_date (date), last_modified (date)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2026-P-5454-0009 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | References 7 - Smarr, M. M., et al. (2016). Urinary paracetamol and time-to-pregnancy. Human Reproduction, 31(9), 2119-2127. URL: https://pubmed.ncbi.nlm.nih.gov/27412248/ | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:42:39Z | 0 | 0 | 09000064b92d5011 | |||
| FDA-2026-P-5454-0014 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 12 - de Araújo-Ramos, A. T., et al. (2026). Differential disruption of gonadal development by DEHP and paracetamol in male and female Wistar rats. Reproductive Toxicology, 141, 109183. URL: https://doi.org/10.1016/j.reprotox.2026.109183 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:42:56Z | 0 | 0 | 09000064b92d5031 | |||
| FDA-2026-P-5454-0015 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 13 - Laursen, T. Q., et al. (2024). Maternal intake of paracetamol during pregnancy and biomarkers of male fecundity in young adult sons. Reproductive Toxicology, 127, 108626. URL: https://doi.org/10.1016/j.reprotox.2024.108626 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:43:00Z | 0 | 0 | 09000064b92d5032 | |||
| FDA-2026-P-5454-0002 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Acknowledgment Letter from FDA DMB to Americans for Scientific Integrity | Other | Acknowledgement Letter/Receipt | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T04:00:00Z | 2026-05-14T17:41:43Z | 0 | 0 | 09000064b92d4fe9 | ||
| FDA-2026-P-5454-0001 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Citizen Petition from Americans for Scientific Integrity | Other | Citizen Petition | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T04:00:00Z | 2026-05-14T17:41:38Z | 1 | 0 | 09000064b92d4fe7 | ||
| FDA-2026-P-5454-0011 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 9 - Carlsen, L. N., et al. (2024). Overuse of analgesics can affect the fertility biomarker Anti-Müllerian Hormone in females. A translational study. Cephalalgia, 44(11). URL: https://doi.org/10.1177/03331024241290530 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:42:46Z | 0 | 0 | 09000064b92d5013 | |||
| FDA-2026-P-5454-0004 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | References 2 - Fisher, B. G., et al. (2016). Prenatal paracetamol exposure is associated with shorter anogenital distance in male infants. Human Reproduction, 31(11), 2642-2650. URL: https://pubmed.ncbi.nlm.nih.gov/27609981/ | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:41:58Z | 0 | 0 | 09000064b92d500c | |||
| FDA-2026-P-5454-0013 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 11 - Wu, T., et al. (2024). Prenatal acetaminophen exposure and the developing ovary: time, dose, and course consequences for fetal mice. Food and Chemical Toxicology, 189, 114679. URL: https://doi.org/10.1016/j.fct.2024.114679 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:42:53Z | 0 | 0 | 09000064b92d5030 | |||
| FDA-2026-P-5454-0017 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 15 - Lee, C. Y., et al. (2023). Effects of acetaminophen on reproductive activities in male golden hamsters. Development & Reproduction, 27(1), 25-37. URL: https://doi.org/10.12717/DR.2023.27.1.25 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:43:26Z | 0 | 0 | 09000064b92d5034 | |||
| FDA-2026-P-5454-0021 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 19 - Eletri, L., et al. (2026). Association between in utero exposure to acetaminophen and external genital tract malformations in boys and girls: a systematic review and meta-analysis. Human Reproduction, 41(3), 427-442. URL: https://doi.org/10.1093/humrep/deaf253 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:43:53Z | 0 | 0 | 09000064b92d5038 | |||
| FDA-2026-P-5454-0003 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | References 1 - Ernstsen, C., et al. (2026). Prenatal paracetamol modulates sexually dimorphic behaviour and steroidogenesis in adult male and female mice. Reproduction, 171(2). URL: https://doi.org/10.1093/reprod/xaag007 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:41:54Z | 0 | 0 | 09000064b92d500b | |||
| FDA-2026-P-5454-0006 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | References 4 - Guzmán-Montemayor, A. J., et al. (2026). Prenatal, but not neonatal, paracetamol exposure disrupts neuroendocrine regulation of stress and emotional behavior in adult male rats. Physiology & Behavior, 308, 115261. URL: https://doi.org/10.1016/j.physbeh.2026.115261 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:42:16Z | 0 | 0 | 09000064b92d500e | |||
| FDA-2026-P-5454-0007 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | References 5 - Górawski, F., et al. (2026). Sex-dependent effects of early-life paracetamol exposure on behavior and monoamines in the rat central nervous system. Chemico-Biological Interactions, 427, 111937. URL: https://doi.org/10.1016/j.cbi.2026.111937 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:42:31Z | 0 | 0 | 09000064b92d500f | |||
| FDA-2026-P-5454-0005 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 3 - Lind, D. V., et al. (2017). Maternal use of mild analgesics during pregnancy associated with reduced anogenital distance in sons. Human Reproduction, 32(1), 149-155. URL: https://pubmed.ncbi.nlm.nih.gov/27852690/ | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:42:12Z | 0 | 0 | 09000064b92d500d | |||
| FDA-2026-P-5454-0018 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 16 - Xu, M., et al. (2024). Association of acetaminophen use with perinatal outcomes among pregnant women: a retrospective cohort study with propensity score matching. BMC Pregnancy and Childbirth, 24, 268. URL: https://doi.org/10.1186/s12884-024-06480-5 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:43:29Z | 0 | 0 | 09000064b92d5035 | |||
| FDA-2026-P-5454-0023 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 21 - OFIRMEV (acetaminophen) Injection Package Insert. (2018). Mallinckrodt Hospital Products Inc. | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:44:02Z | 0 | 0 | 09000064b92d503a | |||
| FDA-2026-P-5454-0020 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 18 - Rehfeld, A., et al. (2022). Human sperm cells can form paracetamol metabolite AM404 that directly interferes with sperm calcium signalling and function through a CatSper-dependent mechanism. Human Reproduction, 37(5), 922-935. URL: https://doi.org/10.1093/humrep/deac042 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:43:48Z | 0 | 0 | 09000064b92d5037 | |||
| FDA-2026-P-5454-0022 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 20 - Kougias, D. G., et al. (2025). A quantitative weight-of-evidence review of preclinical studies examining the potential developmental and reproductive toxicity of acetaminophen. Critical Reviews in Toxicology, 55(2), 179-226. URL: https://doi.org/10.1080/10408444.2024.2446471 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:43:58Z | 0 | 0 | 09000064b92d5039 | |||
| FDA-2026-P-5454-0010 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | References 8 - Nielsen, B. S., et al. (2025). Paracetamol disrupts early embryogenesis by cell cycle inhibition. Human Reproduction, 40(10), 1860-1876. URL: https://doi.org/10.1093/humrep/deaf116 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:42:42Z | 0 | 0 | 09000064b92d5012 | |||
| FDA-2026-P-5454-0019 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 17 - Zafeiri, A., et al. (2022). Maternal over-the-counter analgesics use during pregnancy and adverse perinatal outcomes: cohort study of 151,141 singleton pregnancies. BMJ Open, 12(5), e048092. URL: https://doi.org/10.1136/bmjopen-2020-048092 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:43:32Z | 0 | 0 | 09000064b92d5036 | |||
| FDA-2026-P-5454-0008 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | References 6 - Lecante, L. L., et al. (2022). Acetaminophen interferes with the first trimester human fetal ovary development in an ex vivo model. Journal of Clinical Endocrinology & Metabolism, 107(6), 1647-1661. URL: https://pubmed.ncbi.nlm.nih.gov/35147701/ | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:42:35Z | 0 | 0 | 09000064b92d5010 | |||
| FDA-2026-P-5454-0012 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 10 - Liu, F., et al. (2024). Maternal administration of acetaminophen affects meiosis through its metabolite NAPQI targeting SIRT7 in fetal oocytes. Antioxidants & Redox Signaling, 41, 93-109. URL: https://doi.org/10.1089/ars.2023.0270 | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:42:50Z | 0 | 0 | 09000064b92d502f | |||
| FDA-2026-P-5454-0016 | FDA | Request that the FDA take action to amend OTC acetaminophen labeling regarding reproductive toxicity, fertility impairment, and developmental endocrine disruption FDA-2026-P-5454 | Reference 14 - Andreasen, S. M., et al. (2025). Maternal urinary paracetamol concentrations and self-reported paracetamol use in mid-gestation: association to reduced anogenital distance in offspring from infancy to 9 years. Reproductive Toxicology, 135, 108946. URL: https://pubmed.ncbi.nlm.nih.gov/40374128/ | Supporting & Related Material | Background Material | 2026-05-14T04:00:00Z | 2026 | 5 | 2026-05-14T17:43:22Z | 0 | 0 | 09000064b92d5033 |
Advanced export
JSON shape: default, array, newline-delimited, object
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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;