Dapsone
Dapsone is a sulfone medicine used as a tablet for dermatitis herpetiformis (an itchy, blistering skin condition) and leprosy, and as a topical gel for acne vulgaris.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 19 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Dapsone is a sulfone medicine, on the market since about 1979 and available generically, used as tablets for dermatitis herpetiformis (an itchy, blistering rash, where it is a long-standing first choice) and leprosy, and as a gel for acne. The gel is usually well tolerated, with dryness, redness, oiliness or peeling where it is applied. Either form can affect the blood, causing methemoglobinemia (blood that carries less oxygen) or red blood cell breakdown, especially with G6PD deficiency, so bluish-gray lips or nail beds need help right away. Tablets need regular blood counts, and a fever, sore throat or blistering rash while taking them needs prompt medical attention.
Clinical pearls
- Using benzoyl peroxide alongside dapsone gel can temporarily turn skin or facial hair yellow or orange.
- Acetaminophen, benzocaine numbing products, nitrates and nitrofurantoin can add to the methemoglobinemia risk, so mention dapsone to other prescribers.
- Trimethoprim/sulfamethoxazole, a common antibiotic, raises dapsone levels, so flag dapsone whenever a new antibiotic is prescribed.
- Give the gel about 12 weeks before judging it, and keep it away from the eyes, mouth and vagina.
Patient information guide A plain-language walkthrough of Dapsone, written from its FDA label.
What Dapsone is used for
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Dapsone is used differently depending on the product.
- Dapsone tablets (oral): dermatitis herpetiformis.
- Dapsone tablets (oral): all forms of leprosy except proven dapsone resistance.
- Aczone Gel 7.5% and Dapsone gel 7.5% (topical): acne vulgaris in patients 9 years and older.
How Dapsone works
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Against the leprosy bacteria, dapsone kills them and also stops their growth, based on mouse studies. Its mechanism in dermatitis herpetiformis and in acne is not known.
Resistance to oral dapsone has been reported in leprosy. That is why it is started with other anti-leprosy medicines.
Dapsone dosage
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Tablets are taken by mouth, and your prescriber adjusts the amount to your condition. Gels go on the skin only.
- Dapsone tablets for dermatitis herpetiformis: the dose is lowered to the minimum that works. A gluten-free diet can allow many people to reduce or stop dapsone over time.
- Dapsone tablets for leprosy: taken daily without interruption, together with other anti-leprosy drugs.
- Aczone Gel 7.5%: thin, pea-sized layer once daily to the face, after washing and drying the skin.
- Dapsone gel 5%: thin, pea-sized layer twice daily to acne areas.
Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Dapsone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Dermatitis herpetiformis (oral tablet)
- Individually titrated, starting in adults with 50 mg daily and correspondingly smaller doses in children
- If full control is not achieved within the range of 50 to 300 mg daily, higher doses may be tried
- Reduce to a minimum maintenance level as soon as possible
- Patients with high acetylation rates or receiving treatment affecting acetylation may require a dosage adjustment
- Leprosy (multidrug program)
- Dapsone maintained at the full dosage of 100 mg daily without interruption (with corresponding smaller doses for children), commenced in combination with one or more anti-leprosy drugs
- Smaller doses for children
- Bacteriologically negative tuberculoid and indeterminate leprosy
- Dapsone 100 mg daily with six months of Rifampin 600 mg daily (WHO: Rifampin may be replaced by 600 mg monthly, if supervised)
- Dapsone continued until all signs of clinical activity are controlled, usually an additional six months, then an additional three years for tuberculoid and indeterminate patients and five years for borderline tuberculoid patients
- Lepromatous and borderline lepromatous leprosy
- Dapsone 100 mg daily with two years of Rifampin 600 mg daily (WHO: may be replaced by 600 mg Rifampin monthly, if supervised)
- A third drug may be added, usually Clofazamine 50 to100 mg daily or Ethionamide 250 to 500 mg daily
- Dapsone 100 mg daily continued 3 to10 years until all signs of clinical activity are controlled with skin scrapings and biopsies neg
- Acne vulgaris (Aczone 7.5% topical gel)
- After gently washing and patting skin dry, apply approximately a pea-sized amount in a thin layer to the entire face once daily
- A thin layer may also be applied to other affected areas once daily
- Rub in gently and completely
- If no improvement after 12 weeks, reassess treatment. For topical use only
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Dermatitis herpetiformis The dosage should be individually titrated starting in adults with 50 mg daily and correspondingly smaller doses in children. If full control is not achieved within the range of 50 to 300 mg daily, higher doses may be tried. Dosage should be reduced to a minimum maintenance level as soon as possible. In responsive patients there is a prompt reduction in pruritus followed by clearance of skin lesions. There is no effect on the gastrointestinal component of the disease. Dapsone levels are influenced by acetylation rates. Patients with high acetylation rates, or who are receiving treatment affecting acetylation may require an adjustment in dosage. A strict gluten free diet is an option for the patient to elect, permitting many to reduce or eliminate the need for Dapsone; the average time for dosage reduction is 8 months with a range of 4 months to 2 1/2 years and for dosage elimination 29 months with a range of 6 months to 9 years. Leprosy In order to reduce secondary Dapsone resistance, the WHO Expert Committee on Leprosy and the USPHS at Carville, LA, recommended that Dapsone should be commenced in combination with one or more anti-leprosy drugs. In the multidrug program Dapsone should be maintained at the full dosage of 100 mg daily without interruption (with corresponding smaller doses for children) and provided to all patients who have sensitive organisms with new or recrudescent disease or who have not yet completed a two year course of Dapsone monotherapy. For advice and other drugs, the USPHS at Carville, LA (1-800-642-2477) should be contacted. Before using other drugs consult appropriate product labeling. In bacteriologically negative tuberculoid and indeterminate disease, the recommendation is the coadministration of Dapsone 100 mg daily with six months of Rifampin 600 mg daily. Under WHO, daily Rifampin may be replaced by 600 mg Rifampin monthly, if supervised. The Dapsone is continued until all signs of clinical activity are controlled - usually after an additional six months. Then Dapsone should be continued for an additional three years for tuberculoid and indeterminate patients and for five years for borderline tuberculoid patients. In lepromatous and borderline lepromatous patients, the recommendation is the coadministration of Dapsone 100 mg daily with two years of Rifampin 600 mg daily.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Dapsone side effects
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The most common effects are at the gel application site.
Common side effects
- Dryness at the gel application site
- Redness (erythema) at the application site
- Oiliness or peeling at the application site
- Application site reactions
- Headache
- Stuffy or runny nose and sore throat (nasopharyngitis)
- Headache and cold-like symptoms (reported in gel trials)
When to get medical help
- Bluish-gray color of the lips, inside of the mouth or nail beds (cyanosis, a sign of methemoglobinemia). Stop the gel and get medical help right away.
- Sore throat, fever, pale skin, purple spots (purpura) or yellowing of the skin or eyes (jaundice), especially with tablets.
- Signs of hemolytic anemia (red blood cells breaking down too fast). Stop the gel and call your doctor.
- New or severe skin reactions such as blistering, peeling or widespread rash. Tablets must be stopped promptly.
- Muscle weakness or loss of movement (peripheral neuropathy) reported with oral dapsone.
- Swelling of the face, lips or eyes after using the gel.
- Mood changes such as depression or psychosis, and suicide attempts, were reported in gel trials.
Get help right away for bluish-gray lips or nails, signs of anemia, severe skin reactions, facial swelling or muscle weakness.
Dapsone warnings and precautions
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- Methemoglobinemia: blood carries less oxygen. Signs include slate-gray color of lips, mouth and nail beds, and may be delayed by hours. Hospitalizations have been reported with the gel.
- Hemolysis: red blood cells break down, more likely with G6PD deficiency.
- Blood disorders with tablets: deaths have been reported from agranulocytosis and aplastic anemia. Regular blood counts are advised.
- Skin reactions with tablets: serious reactions can occur. Stop promptly if new or toxic skin reactions appear.
- Nerve problems: muscle weakness with oral dapsone.
Dapsone interactions
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Several medicines can raise the risk of blood problems with dapsone.
- TMP/SMX: raises dapsone levels.
- Oral dapsone or antimalarials with the gel: possible hemolysis.
- Methemoglobin-inducing drugs such as sulfonamides, acetaminophen, benzocaine, nitrates and phenytoin: higher methemoglobinemia risk.
- Rifampin, anticonvulsants, St. John’s wort: may raise a hemolysis-linked metabolite.
- Pyrimethamine and other folic acid antagonists: more blood reactions.
- Benzoyl peroxide: temporary yellow or orange skin discoloration.
Interactions listed in the FDA-approved label
From the Dapsone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Trimethoprim/sulfamethoxazole (TMP/SMX): Levels of dapsone and its metabolites increased in the presence of TMP/SMX; dapsone AUC rose about 40%, N-acetyl-dapsone about 20%, and dapsone hydroxylamine more than doubled, while TMP and SMX levels were essentially unchanged.
- Topical benzoyl peroxide: Used with dapsone gel may cause temporary local yellow or orange discoloration of the skin and facial hair (7 of 95 subjects), resolving in 4 to 57 days.
- Rifampin, anticonvulsants, St. John's wort: May increase the formation of dapsone hydroxylamine, a metabolite associated with hemolysis.
- Folic acid antagonists such as pyrimethamine: With oral dapsone, have been noted to possibly increase the likelihood of hematologic reactions.
- Drugs that induce methemoglobinemia (sulfonamides, acetaminophen, benzocaine, chloroquine, nitrates and nitrites, nitrofurantoin, phenobarbital, phenytoin, primaquine, quinine, others): Concomitant use with dapsone gel may increase the risk of developing methemoglobinemia. See Warnings and Precautions (5.1)
Read the label’s full interactions text
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. Folic acid antagonists such as pyrimethamine may increase the likelihood of hematologic reactions. A modest interaction has been reported for patients receiving 100 mg Dapsone daily in combination with trimethoprim 5 mg/kg q6h. On Day 7, the serum Dapsone levels averaged 2.1 ± 1.0 mcg/mL in comparison to 1.5 ± 0.5 mcg/mL for Dapsone alone. On Day 7, trimethoprim levels averaged 18.4 ± 5.2 mcg/mL in comparison to 12.4 ± 4.5 mcg/mL for patients not receiving Dapsone. Thus, there is a mutual interaction between Dapsone and trimethoprim in which each raises the level of the other about 1.5 times. A crossover study 1 designed to assess the potential of a drug interaction between Dapsone, 100 mg/day and trimethoprim, 200 mg every 12 hours, in eight asymptomatic HIV positive volunteers (average CD4 count 524 cells/mm 3 ) demonstrated that there was not a significant drug intreraction between Dapsone and trimethoprim. However, an earlier report 2 also by Lee et al, in 78 HIV infected patients with acute Pneumocystis carinii pneumonia, receiving Dapsone, 100 mg/day and higher trimethoprim dose, 20 mg/kg/day, demonstrated that the serum levels of Dapsone were increased by 40% and trimethoprim levels were increased by 48% when the drugs were administered concurrently.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Dapsone
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- Allergy to dapsone or its derivatives.
- G6PD deficiency.
- Methemoglobinemia, congenital or idiopathic (avoid gel).
- Severe anemia or severe heart and lung disease.
- Pregnancy: no human data for the gel.
- Breastfeeding: oral dapsone passes into milk and can affect infants.
- Children: dapsone gel 5% not recommended under age 12.
- Older adults: gel trials had too few people 65 and over to assess differences.
Dapsone overdose
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Too much dapsone can cause nausea, vomiting and hyperexcitability within minutes to 24 hours. Methemoglobin-related depression, seizures or severe cyanosis need prompt treatment. Methylene blue is the usual treatment, but it should not be given to people with fully expressed G6PD deficiency.
What Dapsone does in the body
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Against Mycobacterium leprae, dapsone both kills and halts growth of the bacteria in mouse studies. Oral dapsone can cause dose-related hemolysis, and dapsone can raise methemoglobin levels.
How your body processes Dapsone
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With dapsone gel 7.5%, steady state is reached within 7 days. Total exposure to the body is expected to be about 1% of that from a 100 mg oral dose. Gender, race and age (12 to 15 years versus 16 and older) did not appear to change levels with the 5% gel. TMP/SMX raised dapsone levels by about 40%.
How to store Dapsone
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Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Dapsone
215 supplements and herbal products have documented interactions with Dapsone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 167
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Dapsone has been associated with lower levels of 7 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 6
- Moderate · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Dapsone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Dapsone — the kind of thing our pharmacy team would talk through with you at the counter.
What is dapsone used for?
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How do I use the gel?
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What side effects should I expect?
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When should I get help right away?
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Do I need blood tests?
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Is it safe in pregnancy or breastfeeding?
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Is Dapsone available over the counter?
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When was Dapsone first available?
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Who makes Dapsone?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Dapsone on HelloPharmacist
Dapsone forms and strengths (how it comes)
Dapsone is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Dapsone inactive ingredients by manufacturer.
Tablet
How this form is used
- Dapsone tablets are used for dermatitis herpetiformis.
- Dapsone tablets are used for all forms of leprosy except proven dapsone resistance.
- Dapsone tablets for dermatitis herpetiformis are titrated to the individual, then reduced to the lowest effective maintenance level.
- Dapsone tablets for leprosy are started together with other anti-leprosy drugs and taken daily without interruption.
- Dapsone tablets require frequent blood counts.
Topical cream, ointment or gel
How this form is used
- Aczone Gel 7.5% is used on the skin for acne vulgaris in patients 9 years and older.
- Dapsone gel 7.5% is used on the skin for acne vulgaris in patients 9 years and older.
- Aczone Gel 7.5% is applied once daily as a thin, pea-sized layer to the face after washing and drying the skin.
- Dapsone gel 5% is applied twice daily to acne-affected areas, and hands are washed afterward.
- Aczone and Dapsone gels are for skin use only, not for the mouth, eyes or vagina.
- Aczone and Dapsone gels should be reassessed if there is no improvement after 12 weeks.
Dapsone on the U.S. market: products, makers and brands
How Dapsone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
28 companies list 49 Dapsone product records with the FDA, mostly as tablet, topical cream, ointment or gel; the earliest marketing or approval year on record is 1979. Brand names on the directory include Aczone; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (17) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Dapsone is used (Medicaid data)
A general measure of how commonly Dapsone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Dapsone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Dapsone prescribed? Of the 1,601 medications we measure, Dapsone ranks #663 by Medicaid prescriptions — more than 59% of them.
Utilization by Dapsone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
dapsone 0.05 MG/MG Topical Gel Most dispensed
Summed across the 14 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 607295
dapsone 100 MG Oral Tablet
Summed across the 6 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197557
dapsone 0.075 MG/MG Topical Gel
Summed across the 15 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1741905
dapsone 25 MG Oral Tablet
Summed across the 5 of 43 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197558
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dapsone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 40 of 146 listed Dapsone NDCs with Medicaid activity.
Compare Dapsone products
A representative set of FDA-listed product records for Dapsone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 25 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 25 mg | Oral | AvKARE × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | ANDA | View NDC → |
| 25 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 100 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 100 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 25 mg | Oral | Everest Life Sciences. LLC | ANDA | View NDC → |
| 100 mg | Oral | Everest Life Sciences. LLC | ANDA | View NDC → |
| 25 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 100 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 25 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 100 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 25 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Solis Pharmaceuticals Inc. | ANDA | View NDC → |
| 100 mg | Oral | Solis Pharmaceuticals Inc. | ANDA | View NDC → |
| 25 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Viona Pharmaceuticals Inc | ANDA | View NDC → |
| 100 mg | Oral | Viona Pharmaceuticals Inc | ANDA | View NDC → |
| 25 mg | Oral | Westminster Pharmaceuticals, LLC × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Westminster Pharmaceuticals, LLC × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 100 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 💊Topical cream, ointment or gel | ||||
| 50 mg/g | Topical | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 75 mg/g | Topical | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 50 mg/g | Topical | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 75 mg/g | Topical | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 75 mg/g | Topical | Almirall, LLC | NDA | View NDC → |
| 50 mg/g | Topical | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 50 mg/g | Topical | Aurobindo Pharma Limited | ANDA | View NDC → |
| 50 mg/g | Topical | Cosette Pharmaceuticals, Inc. | ANDA | View NDC → |
| 50 mg/g | Topical | Mayne Pharma | ANDA | View NDC → |
| 75 mg/g | Topical | Mayne Pharma Commercial LLC | ANDA | View NDC → |
| 75 mg/g | Topical | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 50 mg/g | Topical | Northstar Rx Llc | ANDA | View NDC → |
| 75 mg/g | Topical | Northstar Rx Llc | ANDA | View NDC → |
| 50 mg/g | Topical | Pacific Pharma, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 50 mg/g | Topical | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 75 mg/g | Topical | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 75 mg/g | Topical | Torrent Pharmaceuticals Limited | ANDA | View NDC → |
| 75 mg/g | Topical | Trupharma, LLC | ANDA | View NDC → |
| 75 mg/g | Topical | Viona Pharmaceuticals Inc | ANDA | View NDC → |
| 75 mg/g | Topical | Zydus Lifesciences Limited | ANDA | View NDC → |
Showing 49 of 49 products — FDA National Drug Code Directory. See every product, package size and price: browse all 49 Dapsone NDCs →
Dapsone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Dapsone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Dapsone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Dapsone FDA approval history
How Dapsone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Dapsone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 3 Dapsone recalls since July 2021, covering 4 product listings. All of them are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- 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 p… Lots: Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026 FDA record D-0172-2025 →
- 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… Lots: Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026. FDA record D-0171-2025 →
- 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. Lots: Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026 FDA record D-0038-2025 →
- 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. Lots: Lot #: T400512, Exp 02/28/2026 FDA record D-0011-2025 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 3108 2 dose forms · 5 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 371689In current FDA listings -
Dose form (SCDF) Topical Gel RxCUI 607294In current FDA listings
Look up RxCUI 3108 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Dapsone supply and shortage status
Whether Dapsone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Dapsone costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Gel · Topical | 75 mg/g | $0.715–$0.799 per gram | NDC details & price history |
| Gel · Topical | 50 mg/g | $0.664–$0.675 per gram | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Dapsone brand names
Dapsone is sold under one brand name in the FDA directory — Aczone. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Dapsone: manufacturers and labelers
28 companies list Dapsone products with the FDA. By number of product records, the largest are Sun Pharmaceutical Industries, Inc., Westminster Pharmaceuticals, LLC, Viona Pharmaceuticals Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 4 more on the FDA NDC directory.
Dapsone drug class (RxNorm)
Dapsone belongs to the Sulfone class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Dapsone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Westminster Pharmaceuticals, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →