Quick answers
- What is Dinoprostone used for?
- The FDA-approved label (Prepidil, Pharmacia & Upjohn Company LLC, October 22, 2025) says: “PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dinoprostone have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dinoprostone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dinoprostone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dinoprostone?
- 2 companies list prescription products of Dinoprostone in the FDA NDC Directory, including Ferring Pharmaceuticals Inc. and Pharmacia & Upjohn Company LLC.
What Dinoprostone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.
— FDA label: Prepidil, Pharmacia & Upjohn Company LLC, effective October 22, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Ferring Pharmaceuticals Inc.1 product
- Pharmacia & Upjohn Company LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019617 PREPIDIL | Pfizer | December 9, 1992 | 8, latest July 5, 2017 2017: Labeling · 2015: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
| NDA020411 CERVIDIL | Ferring Pharms Inc | March 30, 1995 | 21, latest July 7, 2020 2020: Labeling · 2010: Labeling · 2006: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 208397, 309922, 597957, 597959 |
|---|---|
| SPL set ID of the quoted label | ab03de5b-782c-4f81-a8dc-7ef9969dd0cf |
| FDA labels (SPL) | 2 |
| FDA applications | NDA019617, NDA020411 |
| Active ingredients (FDA) | DINOPROSTONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Prepidil, Pharmacia & Upjohn Company LLC, effective October 22, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →