Quick answers
- What is Doxylamine succinate and pyridoxine hydrochloride used for?
- The FDA-approved label (Diclegis, Duchesnay USA, Inc., December 3, 2025) says: “DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use DICLEGIS has not been studied in women with hyperemesis gravidarum. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Doxylamine succinate and pyridoxine hydrochloride have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Doxylamine succinate and pyridoxine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Doxylamine succinate and pyridoxine hydrochloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started August 7, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Doxylamine succinate and pyridoxine hydrochloride?
- 6 companies list prescription products of Doxylamine succinate and pyridoxine hydrochloride in the FDA NDC Directory, including Duchesnay USA, Inc., Bryant Ranch Prepack and Bionpharma Inc..
What Doxylamine succinate and pyridoxine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use DICLEGIS has not been studied in women with hyperemesis gravidarum. …
— FDA label: Diclegis, Duchesnay USA, Inc., effective December 3, 2025. Read the full label on DailyMed →
The FDA has 7 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 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| doxylamine succinate 10 mg · pyridoxine hydrochloride 10 mg tablet, delayed release | Generic | $1.11 per tablet |
| doxylamine succinate 10 mg · pyridoxine hydrochloride 10 mg tablet, delayed release | Brand: Diclegis | $1.68 per tablet |
| doxylamine succinate 20 mg · pyridoxine hydrochloride 20 mg tablet, extended release | Brand: Bonjesta | $11.11 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Duchesnay USA, Inc.2 products
- Bryant Ranch Prepack2 products
- Bionpharma Inc.1 product
- Par Health USA, LLC1 product
- Actavis Pharma, Inc.1 product
- Analog Pharma1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021876 DICLEGIS | Duchesnay | April 8, 2013 | 11, latest October 31, 2022 2022: Labeling · 2018: Labeling · 2016: Manufacturing (CMC) |
| NDA209661 BONJESTA | Duchesnay | November 7, 2016 | 3, latest October 31, 2022 2022: Labeling · 2022: Manufacturing (CMC) · 2018: Labeling |
Generic approvals (3)
- ANDA205811Actavis Labs Fl Inc · August 19, 2016
- ANDA208518Ph Health · December 6, 2017
- ANDA217000Bionpharma · August 4, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 7, 2026 · Class III · Ongoing · D-0822-2026
Presence of Foreign Tablets/Capsules
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20. — Bionpharma Inc.
-
January 18, 2022 · Class II · Terminated · D-0461-2022
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Ph — Teva Pharmaceuticals USA
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1375948, 1375954, 1999651, 1999657 |
|---|---|
| SPL set ID of the quoted label | 8bde08f6-e8bd-4e90-baa7-82e01876a86a |
| FDA labels (SPL) | 7 |
| FDA applications | NDA021876, NDA209661, 3 ANDA |
| Active ingredients (FDA) | DOXYLAMINE / PYRIDOXINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Diclegis, Duchesnay USA, Inc., effective December 3, 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 →