Over-the-counter medicine
Doxylamine First approved as Decapryn
Doxylamine (Decapryn) is an over-the-counter medicine with an FDA approval on record since 1948. FDA's NDC Directory lists it from 35 generic labelers, and pharmacies paid $0.116 per gs sleep aid 25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- Over the counter
Check it at the source: the doxylamine FDA label on DailyMed (effective November 14, 2025, L. Perrigo Company); the NDA 6412 record on Drugs@FDA; every doxylamine label on DailyMed.
Highlights of the record
FDA label of November 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagehelps to reduce difficulty in falling asleep
Forms and strengths
- 25 mg
Tablet; coated tablet.
On the market
- Earliest approval on file
- April 7, 1948 Decapryn, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first October 8, 1985; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 35 of which 35 under generic applications, 0 under brand applications, repackagers included; 3 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.116 per tablet Gs sleep aid 25 mg tablet
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,985 through July 30, 2026
What is doxylamine used for?
From the label: indications and usagehelps to reduce difficulty in falling asleep
FDA pharmacologic class: Antihistamine.
Source: FDA drug label (Good sense sleep aid), L. Perrigo Company, effective November 14, 2025 (SPL set f0a0eb93-96e0-432b-9b82-f0e891483be0), via openFDA; the full label on DailyMed
Is there a generic for doxylamine (Decapryn)?
The FDA approved the first generic doxylamine on October 8, 1985. 3 generic applications are approved; 2 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 from 35 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1948 earliest approval on file
- 1985 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for doxylamine (Decapryn)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.116 per Gs sleep aid 25 mg tablet, down 4% from $0.120 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.
- Gs sleep aid 25 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ft sleep aid 25 mg tablet | Generic | $0.116 per tablet | $3.47 | -4% |
| Gnp nighttime sleep 25 mg tablet | Generic | $0.116 per tablet | $3.47 | -4% |
| Gs sleep aid 25 mg tablet | Generic | $0.116 per tablet | $3.47 | -4% |
| Gs sleep aid ultra 25 mg tablet | Generic | $0.116 per tablet | $3.47 | -4% |
| Sleep aid 25 mg tablet | Generic | $0.116 per tablet | $3.47 | -4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is doxylamine in shortage?
No doxylamine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated January 12, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Doxylamine Succinate and Pyridoxine Hydrochloride, Tablet, Delayed Release, 10 mg; 10 mg (NDC 0378-4615-01) | Mylan Pharmaceuticals Inc., a Viatris Company | To Be Discontinued | January 12, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the doxylamine label say about other medicines?
The doxylamine label names no other medicine on this site. The labels of 1 other medicine name doxylamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Good sense sleep aid), L. Perrigo Company, effective November 14, 2025 (SPL set f0a0eb93-96e0-432b-9b82-f0e891483be0), via openFDA; the full label on DailyMed
What do FAERS reports show for doxylamine?
The FDA Adverse Event Reporting System holds 5,985 reports that list doxylamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 443 are coded as a death and 864 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 next?
- Other antihistamines
- the pharmacologic class, with prices and generics
- Doxylamine side effects
- the label's list beside FAERS reports
- Doxylamine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other