# Cervidil (dinoprostone vaginal insert) Product · id `maternal:cervidil` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: Cervidil Browse, life stage: Childbirth Browse, care area: Labour and birth ## In plain language Cervidil is a dinoprostone vaginal insert with a US label from Ferring Pharmaceuticals, approved in the United States under application NDA020411. Its US label says it is for starting or continuing cervical ripening in pregnant women at or near term who have a medical or obstetrical reason for labour to be induced. ## Technical summary US approved prostaglandin for cervical ripening before induction. openFDA label set id f3bc9031-0620-4a50-b440-f661cadfeb1d, version 10, effective 2023-06-02, manufacturer Ferring Pharmaceuticals Inc., route vaginal; dosage form extended-release insert, 10 mg dinoprostone per the Drugs@FDA record. Only the US label was read. The label wording is the dataset's copy as of the date fetched. ## Claims, with the population each applies to ## Context: Pregnant women at or near term with a medical or obstetrical indication for induction of labour, US label for Cervidil (NDA020411) Recipient: Maternal; Population: Pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labour, for initiation or continuation of cervical ripening.; Care setting: Not stated in the source; Geography: United States (FDA-approved labelling); Life stage: Pregnancy at or near term; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) ### FDA lists an original approval of NDA020411 for Cervidil (dinoprostone vaginal insert) on 1995-03-30, classified Type 3, new dosage form; the sponsor in Drugs@FDA is Ferring Pharmaceuticals. The US label (version 10, effective 2023-06-02) says Cervidil is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Maternal; Population: Pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labour, for initiation or continuation of cervical ripening.; Care setting: Not stated in the source; Geography: United States (FDA-approved labelling); Life stage: Pregnancy at or near term; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Limitations: The date is the original submission's action date in Drugs@FDA, not the date of the current label. The indication wording is from the openFDA copy of the label and was not compared with the DailyMed page. Approval is not a recommendation for any woman, and labelled uses differ by country. - Last checked: 2026-10-14 - Sources: 1. Supports: FDA new drug application NDA020411, CERVIDIL: openFDA Drugs@FDA record and Drugs@FDA approval history page (Regulator, edition Two retrievals on 2026-10-14. The openFDA drugsfda JSON record (meta.last\_updated 2026-10-13) gives the application number, sponsor, products, active ingredient, identifiers and the submission history with status dates written YYYYMMDD. The Drugs@FDA overview page for the application gives the original approval date with the date written MM/DD/YYYY.) Locator: results\[0\].submissions: original submission (ORIG 1) with status AP. Retrieved 2026-10-14T18:23:44Z. Source state: Current. Snapshot hash: efe6b77bfc1afed8718173a9d1f6ccbcab641d9cfde40ac97f52e9676bc1c05a. How it applies: openFDA drugsfda JSON, CC0. 2. Supports: FDA new drug application NDA020411, CERVIDIL: openFDA Drugs@FDA record and Drugs@FDA approval history page (Regulator, edition Two retrievals on 2026-10-14. The openFDA drugsfda JSON record (meta.last\_updated 2026-10-13) gives the application number, sponsor, products, active ingredient, identifiers and the submission history with status dates written YYYYMMDD. The Drugs@FDA overview page for the application gives the original approval date with the date written MM/DD/YYYY.) Locator: Original Approvals or Tentative Approvals: action date, submission and classification. Retrieved 2026-10-14T18:30:46Z. Source state: Current. Snapshot hash: cc140ad1727ce0984270a9a51fe839f559a2c276f8a795d280c0151970eba772. How it applies: Drugs@FDA overview page; FDA website content is not copyrighted. 3. Supports: CERVIDIL drug label (openFDA record, set id f3bc9031-0620-4a50-b440-f661cadfeb1d) (Label, edition openFDA drug label record, label effective 20230602, dataset last updated 2026-10-13. The openFDA record is the label as of the dataset date; it is not the current label on DailyMed.) Locator: results\[0\].indications\_and\_usage. Retrieved 2026-10-14T18:24:06Z. Source state: Current. Snapshot hash: 0f4a41c3fc1716760af22915d3dd8267b30998f3a297aa051e7da9421e05a9a9. How it applies: openFDA label record, CC0; label version 10. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-nda020411` - Product: Cervidil (dinoprostone vaginal insert) (`maternal:cervidil`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 1995-03-30 - Product version: Cervidil (dinoprostone 10 mg vaginal insert), original approval of NDA020411; labelling read is openFDA label version 10, effective 2023-06-02 - Pathway: NDA - Submission: NDA020411 - Indication: Initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labour. - Jurisdictions: United States; note: United States - Applies to: Recipient: Maternal; Population: Pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labour, for initiation or continuation of cervical ripening.; Care setting: Not stated in the source; Geography: United States (FDA-approved labelling); Life stage: Pregnancy at or near term; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Basis: claim `maternal:claim-fda-nda020411-cervidil` ## Connected pages - Active ingredient (generic name on the label): Dinoprostone (`maternal:dinoprostone`) - Cervical ripening before induction: Induction of labour (`maternal:induction-of-labour`) - Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`) ## Provenance Content hash: 343e910521e13a012d321901b8c7dbbca60c2551f9a63bd82c21ff49c019b26d Last substantive edit: 2026-10-14 Evidence last checked: 2026-10-14