Prescription medicine
Doxylamine and pyridoxine Brand names: Bonjesta, Diclegis; first approved as Bendectin
Doxylamine and pyridoxine (Diclegis) is a prescription medicine with an FDA approval on record since 1956. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $1.09 per unit (Doxylamine-pyridoxine 10-10 mg) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the doxylamine and pyridoxine FDA label on DailyMed (effective December 3, 2025, Duchesnay USA, Inc.); the NDA 10598 record on Drugs@FDA; every doxylamine and pyridoxine label on DailyMed.
Highlights of the record
FDA label of December 3, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Forms and strengths
- 10 mg / 10 mg
- 20 mg / 20 mg
Delayed-release tablet; extended-release tablet.
On the market
- Earliest approval on file
- July 30, 1956 Bendectin, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first August 19, 2016; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 4 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 18, 2033 Bonjesta tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.09 per unit Doxylamine-pyridoxine 10-10 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2022 0 Class I among all firms' recalls; latest August 7, 2026
- FAERS reports
- 522 through July 30, 2026
What is doxylamine and pyridoxine used for?
From the label: indications and usageDICLEGIS 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. DICLEGIS is a fixed dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Conditions named in the indications of doxylamine and pyridoxine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Antihistamine and Vitamin B6 Analog.
Source: FDA drug label (DICLEGIS), Duchesnay USA, Inc., effective December 3, 2025 (SPL set 8bde08f6-e8bd-4e90-baa7-82e01876a86a), via openFDA; the full label on DailyMed
Is there a generic for doxylamine and pyridoxine (Diclegis)?
The FDA approved the first generic doxylamine and pyridoxine on August 19, 2016. 5 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists doxylamine and pyridoxine from 4 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Diclegis tablets; a patent listed only for Bonjesta tablets runs to February 18, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1956 earliest approval on file
- 2016 first generic approved
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for doxylamine and pyridoxine (Diclegis)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.09 per unit (Doxylamine-pyridoxine 10-10 mg), down 16% from $1.31 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Doxylamine-pyridoxine 10-10 mg (generic)
- Diclegis DR 10-10 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Doxylamine-pyridoxine 10-10 mg | Generic | $1.09 per unit | n/a | -16% |
| Bonjesta ER 20-20 mg tablet | Brand | $11.12 per tablet | $333.46 | -0.1% |
| Diclegis DR 10-10 mg tablet | Brand | $1.68 per tablet | $50.28 | -16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has doxylamine and pyridoxine been recalled?
The FDA's Enforcement Report lists 2 recalls naming doxylamine and pyridoxine since 2022: 0 Class I (the most serious), 1 Class II, 1 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 7, 2026 | Class III | Bionpharma Inc. | Presence of Foreign Tablets/Capsules |
| January 18, 2022 | Class II | Teva Pharmaceuticals USA | Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the doxylamine and pyridoxine label say about other medicines?
The doxylamine and pyridoxine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Methadone | drug interactions | Tests for Methadone, Opiates and PCP False positive drug screens for methadone, opiates, and PCP can occur with doxylamine succinate/pyridoxine hydrochloride use. |
Source: FDA drug label (DICLEGIS), Duchesnay USA, Inc., effective December 3, 2025 (SPL set 8bde08f6-e8bd-4e90-baa7-82e01876a86a), via openFDA; the full label on DailyMed
What do FAERS reports show for doxylamine and pyridoxine?
The FDA Adverse Event Reporting System holds 522 reports that list doxylamine and pyridoxine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 104 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as doxylamine and pyridoxine?
7 other medicines are given the same way (oral) and in the same FDA class as doxylamine and pyridoxine or labeled mainly for the same use (nausea and vomiting), the same class first. Nausea and vomiting lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ondansetron | Nausea and vomiting | 60 labelers | $0.0582 per tablet 4 mg tablet | No current entry |
| Meclizine | Nausea and vomiting | 24 labelers | $0.0442 per tablet 12.5 mg tablet | No current entry |
| Prochlorperazine | Nausea and vomiting | 29 labelers | $0.162 per tablet 10 mg tablet | No current entry |
| Dimenhydrinate | Nausea and vomiting | none listed | $0.0575 per tablet 50 mg tablet | No current entry |
| Aprepitant | Nausea and vomiting | 5 labelers | $46.42 per capsule 40 mg capsule | A presentation being discontinued |
| Trimethobenzamide | Nausea and vomiting | 4 labelers | n/a | No current entry |
| Tradipitant | Nausea and vomiting | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as doxylamine and pyridoxine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to doxylamine and pyridoxine
- 7 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Doxylamine and pyridoxine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other