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Prescription medicine · generic available

Dapsone

Brand names: Aczone

Drug class: Sulfone

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

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

NoBoxed warning
To be discontinuedFDA shortage list
4Recalls (FDA reports)
29Companies
1979First FDA approval on file

Quick answers

What is Dapsone used for?
The FDA-approved label (Aczone, Almirall, LLC, October 23, 2025) says: “ACZONE ® (dapsone) Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ACZONE ® Gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Dapsone have a boxed warning?
No. None of the 37 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Dapsone?
The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated March 27, 2026). Ask your pharmacist about alternatives.
Has Dapsone been recalled?
FDA enforcement reports list 4 recalls of products of this medicine; the newest started December 10, 2024 (Class II). A recall usually concerns specific lots, not every product.
Who makes Dapsone?
29 companies list prescription products of Dapsone in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc., Westminster Pharmaceuticals, LLC and Zydus Lifesciences Limited.

What Dapsone is used for

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

ACZONE ® (dapsone) Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ACZONE ® Gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

— FDA label: Aczone, Almirall, LLC, effective October 23, 2025. Read the full label on DailyMed →

The FDA has 37 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 37 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet · Gel
RouteOral · Topical
Prescription products51 in the FDA NDC Directory
Brand namesAczone

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 Dapsone, by strength and form
Strength and formGeneric or brandPharmacies pay
dapsone 100 mg
tablet		 Generic $0.7994 per tablet
dapsone 25 mg
tablet		 Generic $0.4539 per tablet
dapsone 5%
gel		 Generic $0.5828–$0.6911 per gram
15 packages, lowest to highest
dapsone 7.5%
gel		 Generic $0.7475–$0.7923 per gram
16 packages, lowest to highest

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
NDA021794
ACZONE		 AlmirallJuly 7, 2005 8, latest May 18, 2018
2018: Labeling · 2015: Manufacturing (CMC) · 2015: Labeling
NDA207154
ACZONE		 AlmirallFebruary 24, 2016 2, latest September 10, 2019
2019: Efficacy · 2018: Labeling

Generic approvals (23)

Shortage status

To be discontinued · updated March 27, 2026 · first posted March 27, 2026

ProductDapsone, Gel, 7.5% (NDC 69238-1627-6)
CompanyAmneal Pharmaceuticals

Ask your pharmacist whether your product is affected and what the options are.

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. December 10, 2024 · Class II · Ongoing · D-0171-2025

    Crystallization

    Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack — VIONA PHARMACEUTICALS INC

  2. December 10, 2024 · Class II · Ongoing · D-0172-2025

    Crystallization

    Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack — VIONA PHARMACEUTICALS INC

  3. October 29, 2024 · Class II · Ongoing · D-0038-2025

    Crystallization

    Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. — VIONA PHARMACEUTICALS INC

  4. September 24, 2024 · Class II · Ongoing · D-0011-2025

    Crystallization

    Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. — VIONA PHARMACEUTICALS INC

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)197557, 197558, 607295, 1741905, 1741907
SPL set ID of the quoted label22058b7d-a578-4eaa-a476-ac982337f02a
FDA labels (SPL)37
FDA applicationsNDA021794, NDA207154, 23 ANDA
Active ingredients (FDA)DAPSONE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Aczone, Almirall, LLC, effective October 23, 2025; 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 →

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