Prescription medicine
Dapsone Brand names: Aczone
Dapsone (Aczone) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 27 generic labelers, and pharmacies paid $0.664 per gram (Dapsone 5% gel) in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the dapsone FDA label on DailyMed (effective July 20, 2026, Macleods Pharmaceuticals Limited); the NDA 21794 record on Drugs@FDA; every dapsone label on DailyMed.
Highlights of the record
FDA label of July 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDermatitis herpetiformis: (D.H.) Leprosy: All forms of leprosy except for cases of proven dapsone resistance.
Forms and strengths
- 25 mg
- 100 mg
- 50 mg/g
- 75 mg/g
Tablet; gel.
On the market
- Earliest approval on file
- July 7, 2005 Aczone, Almirall; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first July 3, 1979; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 29 of which 27 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 18, 2033 Aczone gel; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.664 per gram Dapsone 5% gel
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 4 since 2024 0 Class I among all firms' recalls; latest December 10, 2024
- FAERS reports
- 10,643 through July 30, 2026
What is dapsone used for?
From the label: indications and usageDermatitis herpetiformis: (D.H.) Leprosy: All forms of leprosy except for cases of proven dapsone resistance.
Conditions named in the indications of dapsone's FDA labels, with every medicine labeled for each:
From other dapsone labelsAcne: Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris.
FDA pharmacologic class: Sulfone.
Source: FDA drug label (Dapsone), Macleods Pharmaceuticals Limited, effective July 20, 2026 (SPL set 839d7440-ba0e-4c56-b648-d374b155cf03), via openFDA; the full label on DailyMed
Is there a generic for dapsone (Aczone)?
The FDA approved the first generic dapsone on July 3, 1979. 27 generic applications are approved; 21 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 dapsone from 27 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 1 patent for Aczone gel, the last expiring on November 18, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2005 earliest approval on file
- 1979 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 dapsone (Aczone)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.664 per gram (Dapsone 5% gel), down 36% from $1.04 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Dapsone 5% gel (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dapsone 100 mg tablet | Generic | $0.806 per tablet | $24.18 | -22% |
| Dapsone 25 mg tablet | Generic | $0.459 per tablet | $13.77 | -18% |
| Dapsone 5% gel | Generic | $0.664 per gram | n/a | -36% |
| Dapsone 7.5% gel pump | Generic | $0.757 per gram | n/a | -40% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is dapsone in shortage?
No dapsone 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 March 27, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Dapsone, Gel, 7.5% (NDC 69238-1627-6) | Amneal Pharmaceuticals | To Be Discontinued | March 27, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has dapsone been recalled?
The FDA's Enforcement Report lists 4 recalls naming dapsone since 2024: 0 Class I (the most serious), 4 Class II, 0 Class III; 4 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 10, 2024 | Class II | VIONA PHARMACEUTICALS INC | Crystallization |
| October 29, 2024 | Class II | VIONA PHARMACEUTICALS INC | Crystallization |
| September 24, 2024 | Class II | VIONA PHARMACEUTICALS INC | Crystallization |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dapsone label say about other medicines?
The dapsone label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 19 other medicines name dapsone. 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 |
|---|---|---|
| Acetaminophen | drug interactions | Use with Drugs that Induce Methemoglobinemia Concomitant use of ACZONE Gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine … |
| Benzocaine | drug interactions | Use with Drugs that Induce Methemoglobinemia Concomitant use of ACZONE Gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine … |
| Benzoyl peroxide | drug interactions | Topical benzoyl peroxide used at the same time as ACZONE Gel, 7.5% may result in temporary local yellow or orange skin discoloration ( 7.2 ). |
| Chloroquine | drug interactions | Use with Drugs that Induce Methemoglobinemia Concomitant use of ACZONE Gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine … |
| Nitrofurantoin | drug interactions | Use with Drugs that Induce Methemoglobinemia Concomitant use of ACZONE Gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine … |
| Nitroglycerin | drug interactions | … acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia [see Warnings and … |
| Phenobarbital | drug interactions | … and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia [see Warnings and Precautions ( 5.1 )]. |
| Phenytoin | drug interactions | … nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia [see Warnings and Precautions ( 5.1 )]. |
| Primaquine | drug interactions | … nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia [see Warnings and Precautions ( 5.1 )]. |
| Pyrimethamine | drug interactions | Folic acid antagonists such as pyrimethamine may increase the likelihood of hematologic reactions. |
| Quinine | drug interactions | … nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia [see Warnings and Precautions ( 5.1 )]. |
| Rifampin | drug interactions | Drug Interactions: Rifampin lowers dapsone levels 7 to 10-fold by accelerating plasma clearance; in leprosy this reduction has not required a change in dosage. |
| Sulfamethoxazole and trimethoprim | drug interactions | Trimethoprim/sulfamethoxazole (TMP/SMX) increases the systemic level of dapsone and its metabolites ( 7.1 ). |
| Trimethoprim | drug interactions | Thus, there is a mutual interaction between dapsone and trimethoprim in which each raises the level of the other about 1.5 times. |
Other labels that name dapsone
Source: FDA drug label (Dapsone), Macleods Pharmaceuticals Limited, effective July 20, 2026 (SPL set 839d7440-ba0e-4c56-b648-d374b155cf03), via openFDA; the full label on DailyMed
What do FAERS reports show for dapsone?
The FDA Adverse Event Reporting System holds 10,643 reports that list dapsone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 934 are coded as a death and 3,831 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
How does dapsone compare with medicines for the same use?
5 side-by-side pages set dapsone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Dapsone side effects
- the label's list beside FAERS reports
- Dapsone shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other