PRUDOXIN ® (doxepin hydrochloride) Cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride, USP is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[ b,e ]oxepin-Δ 11(6H),γ -propylamine hydrochloride. Doxepin hydrochloride has a molecular formula of C 19 H 21 NO•HCl and a molecular weight of 316. PRUDOXIN ® Cream also contains sorbitol, cetyl alcohol, isopropyl myristate, glyceryl stearate, PEG- 100 stearate, petrolatum, benzyl alcohol, titanium dioxide and purified water. The structural formula of doxepin hydrochloride.

What kind of drug is doxepin?

The FDA classifies doxepin as a tricyclic antidepressant. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take doxepin with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run doxepin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is doxepin sold under?

We track 3 doxepin-containing products in the U.S.: Doxepin Hydrochloride, Zonalon and Sinequan. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does doxepin come in?

Across the brands we track, doxepin is currently marketed as capsule, topical, solution and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic doxepin?

Yes. Our catalog lists 1 generic doxepin product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Has doxepin been recalled?

The FDA's Enforcement database lists 1 recall record whose product description mentions doxepin. The most recent: Doxepin Hydrochloride Capsules (Jul 25, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

Doxepin: uses, dosing, side effects & brands

Doxepin is a tricyclic antidepressant sold in the U.S. under 3 brand and generic names, for anxiety disorders, depressive disorder and atopic dermatitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesHow we research

Key facts

Drug class: Tricyclic Antidepressant
Treats: Anxiety Disorders, Depressive Disorder and Atopic Dermatitis
Available as: Capsule · Topical · Solution · Tablet
Sold as: 3 products — Doxepin Hydrochloride, Zonalon and Sinequan
Prescription?: Prescription only
Generic available?: Yes
Typical price: about $5 for a 30-count supply
Boxed warning: Boxed warning

How doxepin is dosed

From the FDA label for Zonalon (application NDA020126). Other doxepin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

A thin film of PRUDOXIN ® Cream should be applied four times each day with at least a 3 to 4 hour interval between applications. There are no data to establish the safety and effectiveness of PRUDOXIN ® Cream when used for greater than 8 days. Chronic use beyond eight days may result in higher systemic levels and should be avoided. Use of PRUDOXIN ® Cream for longer than 8 days may result in an increased likelihood of contact sensitization. The risk for sedation may increase with greater body surface area application of PRUDOXIN ® Cream (See WARNINGS section). Clinical experience has shown that drowsiness is significantly more common in patients applying PRUDOXIN ® Cream to over 10% of body surface area; therefore, patients with greater than 10% of body surface area (see WARNINGS section) affected should be particularly cautioned concerning possible drowsiness and other systemic adverse effects of doxepin. If excessive drowsiness occurs, it may be necessary to do one or more of the following: reduce the body surface area treated, reduce the number of applications per day, reduce the amount of cream applied, or discontinue the drug. Occlusive dressings may increase the absorption of most topical drugs; therefore, occlusive dressings should not be utilized with PRUDOXIN ® Cream.

Doxepin side effects

Controlled Clinical Trials Systemic Adverse Effects: In controlled clinical trials of patients treated with PRUDOXIN ® Cream, the most common systemic adverse event reported was drowsiness. Drowsiness occurred in 71 of 330 (22%) of patients treated with PRUDOXIN ® Cream compared to 7 of 334 (2%) of patients treated with vehicle cream. Drowsiness resulted in the premature discontinuation of the drug in approximately 5% of patients treated with PRUDOXIN ® Cream in controlled clinical trials. Local Site Adverse Effects: In controlled clinical trials of patients treated with PRUDOXIN ® Cream, the most common local site adverse event reported was burning and/or stinging at the site of application. These occurred in 76 of 330 (23%) of patients treated with PRUDOXIN ® Cream compared to 54 of 334 (16%) of patients treated with vehicle cream. Most of these reactions were categorized as "mild"; however, approximately 25% of patients who reported burning and/or stinging reported the reaction as "severe". Four patients treated with PRUDOXIN ® Cream withdrew from the study because of the burning and/or stinging. The table below presents the adverse events reported at an incidence of ≥ 1 % in either PRUDOXIN ® or vehicle cream treatment groups during the trials: Adverse Event PRUDOXIN ® N=330 Vehicle N=334 Burning /Stinging 76 (23.0%) 54 (16.2%) Drowsiness 71 (21.5%) 7 (2.1%) Dry Mouth 1 32…

Every doxepin product we track (3)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Doxepin products
#	Drug	Rating	Type	Form	Generic?	Typical price
1	Doxepin Hydrochloride	70/100	Prescription	Capsule	Generic	$5	View →
2	Zonalon	60/100	Prescription	Topical	Generic

What doxepin pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Doxepin pill imprints
Imprint	Strength	Colour	Shape	Maker
Par;222	150 mg	white, blue	capsule	—
ap;DXP50	50 mg	white	capsule	—
ap;DXP10	10 mg	white	capsule	—
ap;DXP50	50 mg	white	capsule	—
ap;DXP25	25 mg	white, white	capsule	—

Doxepin recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

Doxepin Hydrochloride Capsules
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Alembic Pharmaceuticals Limited · Jul 25, 2025

Frequently asked questions

What is doxepin?: PRUDOXIN ® (doxepin hydrochloride) Cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride, USP is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[ b,e ]oxepin-Δ 11(6H),γ -propylamine hydrochloride. Doxepin hydrochloride has a molecular formula of C 19 H 21 NO•HCl and a molecular weight of 316. PRUDOXIN ® Cream also contains sorbitol, cetyl alcohol, isopropyl myristate, glyceryl stearate, PEG- 100 stearate, petrolatum, benzyl alcohol, titanium dioxide and purified water. The structural formula of doxepin hydrochloride.
What kind of drug is doxepin?: The FDA classifies doxepin as a tricyclic antidepressant. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take doxepin with other medicines?: It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run doxepin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is doxepin sold under?: We track 3 doxepin-containing products in the U.S.: Doxepin Hydrochloride, Zonalon and Sinequan. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does doxepin come in?: Across the brands we track, doxepin is currently marketed as capsule, topical, solution and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic doxepin?

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.