Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Doxepin hydrochloride

Brand names: Silenor, Prudoxin, Zonalon

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

Some labelsBoxed warning
None listedFDA shortage list
1Recalls (FDA reports)
50Companies
1986First FDA approval on file

Quick answers

What is Doxepin hydrochloride used for?
The FDA-approved label (Zonalon, Mylan Pharmaceuticals Inc., June 14, 2017) says: “Zonalon ® Cream is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION.)” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Doxepin hydrochloride have a boxed warning?
The label we quote has no boxed warning, but 74 of 99 FDA labels for this medicine do. Check the label of your own product.
Is there a shortage of Doxepin hydrochloride?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Doxepin hydrochloride been recalled?
FDA enforcement reports list 1 recall of products of this medicine; the newest started July 25, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Doxepin hydrochloride?
50 companies list prescription products of Doxepin hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and Mylan Pharmaceuticals Inc..

What Doxepin hydrochloride is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Zonalon ® Cream is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION.)

— FDA label: Zonalon, Mylan Pharmaceuticals Inc., effective June 14, 2017. Read the full label on DailyMed →

The FDA has 99 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.

74 of 99 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsCapsule · Tablet · Tablet, film coated · Cream · Solution
RouteOral · Topical
Prescription products207 in the FDA NDC Directory
Brand namesSilenor, Prudoxin, Zonalon

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.

NADAC per unit for Doxepin hydrochloride, by strength and form
Strength and formGeneric or brandPharmacies pay
doxepin hydrochloride 10 mg
capsule		 Generic $0.0796 per capsule
doxepin hydrochloride 10 mg/mL
solution		 Generic $0.8878 per mL
doxepin hydrochloride 100 mg
capsule		 Generic $0.3017 per capsule
doxepin hydrochloride 25 mg
capsule		 Generic $0.1476 per capsule
doxepin hydrochloride 3 mg
tablet		 Generic $1.37 per tablet
doxepin hydrochloride 3 mg
tablet, film coated		 Generic $1.37 per tablet
doxepin hydrochloride 5%
cream		 Generic $7.85 per gram
doxepin hydrochloride 50 mg
capsule		 Generic $0.1641 per capsule
doxepin hydrochloride 6 mg
tablet		 Generic $1.41 per tablet
doxepin hydrochloride 6 mg
tablet, film coated		 Generic $1.41 per tablet
doxepin hydrochloride 75 mg
capsule		 Generic $0.2237 per capsule

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.

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.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA020126
ZONALON		 MylanApril 1, 1994 5, latest December 20, 2002
2002: Labeling · 1996: Manufacturing (CMC) · 1995: Manufacturing (CMC)
NDA022036
SILENOR		 CurraxMarch 17, 2010 4, latest October 29, 2020
2020: Labeling · 2016: Manufacturing (CMC) · 2014: Manufacturing (CMC)

Generic approvals (27)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. July 25, 2025 · Class II · Ongoing · D-0566-2025

    CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

    Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, — Alembic Pharmaceuticals Limited

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)966787, 966791, 966793, 966795, 1000048, 1000058, 1000064, 1000070, 1000076, 1000091 … (+3)
SPL set ID of the quoted label5f302247-525e-4acc-852b-00eb1d79af4b
FDA labels (SPL)99
FDA applicationsNDA020126, NDA022036, 27 ANDA
Active ingredients (FDA)DOXEPIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Zonalon, Mylan Pharmaceuticals Inc., effective June 14, 2017; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

Report an error → · Information for medicine makers