FDA-filed SPL labeling · retrieved through openFDA

Dapsone

Dapsone is an antibiotic-type medicine used to treat leprosy and dermatitis herpetiformis in tablet form, and acne vulgaris as a topical gel.

Brand name Aczone
Drug class ⓘ Sulfone
Rx Forms 2 Routes Oral · Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 →

At a glance
Linked label effectiveAug 28, 2025
Clinical labels in scope ⓘ19
AvailabilityRx
Earliest approval/marketing year ⓘ1979
FDA-listed product records ⓘ113
Boxed warningNone found in compared labels
How we combine label and product data →
Other forms & routes:
Topical
⭐ Dapsone at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Dapsone is a versatile medicine available as a tablet for leprosy and dermatitis herpetiformis, and as a topical gel for acne vulgaris. Blood monitoring is essential with the oral form due to the risk of serious blood disorders. Always use it exactly as prescribed and tell your healthcare team about all other medicines you take.
How we write & review this content — our editorial policy →

📖 Dapsone: Patient Information Guide

A plain-language walkthrough of Dapsone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Dapsone is used for several different conditions depending on the form and product used.

  • Dermatitis herpetiformis — Dapsone tablets treat this chronic, itchy blistering skin condition; a gluten-free diet may help reduce the amount of dapsone needed over time
  • Leprosy — Dapsone tablets treat all forms of leprosy where the bacteria have not developed resistance to dapsone; it must be used in combination with other anti-leprosy medicines to prevent resistance
  • Acne vulgaris — Aczone Gel, 7.5% and dapsone gel are applied to the skin to treat acne in patients 9 years and older; this topical form is not used for leprosy or dermatitis herpetiformis
⚙️How it works▾

For leprosy, dapsone works both by killing Mycobacterium leprae (the bacteria that causes leprosy) and by slowing its growth. This dual action — bactericidal and bacteriostatic — helps bring the infection under control. How dapsone works in dermatitis herpetiformis has not been established. The mechanism of action of dapsone gel in treating acne is also not known.

💊How it's taken▾

Dapsone tablets are taken by mouth once daily. Your prescriber will tailor the dose to your condition and response, so always follow their guidance — do not adjust the dose on your own. For leprosy, treatment must not be interrupted and is always combined with other anti-leprosy medicines. For dermatitis herpetiformis, the dose is adjusted down to the lowest effective level, and a strict gluten-free diet may allow some people to reduce or eventually eliminate the need for the tablet over months to years.

Aczone Gel, 7.5% and dapsone gel are applied to the skin — for topical use only. Aczone Gel, 7.5% is applied once daily; dapsone gel, 5% is applied twice daily. Wash and dry skin gently before applying, use about a pea-sized amount, and rub in completely. If there's no improvement after 12 weeks, your prescriber should reassess the treatment.

🤒Side effects — in detail▾

The most common side effects depend on how dapsone is used.

  • Topical gel: oiliness or peeling, dryness, and redness at the site of application
  • Topical gel: temporary yellow or orange skin or hair discoloration if benzoyl peroxide is used at the same time
  • Topical gel (postmarketing reports): rash, facial swelling, or lip/eye swelling
  • Oral dapsone: nausea, abdominal pain, headache
  • Oral dapsone (serious): hemolytic anemia, agranulocytosis (dangerous drop in white blood cells), peripheral neuropathy (nerve damage with muscle weakness)
  • Oral dapsone (serious): severe skin reactions including toxic epidermal necrolysis and blistering

Serious blood problems and severe skin reactions require prompt medical attention. Stop taking dapsone and contact your doctor immediately if you notice any of these signs.

⚠️Warnings & precautions▾

The most critical risk with oral dapsone is serious blood toxicity — including a life-threatening drop in white blood cells (agranulocytosis), aplastic anemia, and hemolytic anemia. Deaths have been reported. Regular blood count monitoring is required, especially in the early months of treatment. Tell your doctor right away if you develop a sore throat, fever, unusual paleness, purple skin spots, or yellowing of the skin or eyes.

  • Methemoglobinemia (low blood oxygen from changes in red blood cells): both oral and topical dapsone can cause this. Signs include bluish or slate-grey coloring of lips, nails, or mouth lining. People with G6PD deficiency or congenital methemoglobinemia are at higher risk. Seek immediate medical care if this occurs.
  • Hemolysis (breakdown of red blood cells): higher risk in people with G6PD deficiency, which is more common in those of African, South Asian, Middle Eastern, or Mediterranean ancestry. Avoid topical dapsone gel in patients also taking oral dapsone or antimalarial drugs.
  • Severe skin reactions: oral dapsone has been associated with toxic epidermal necrolysis and severe blistering — stop the medicine and seek care immediately if a serious skin reaction develops.
  • Peripheral neuropathy (nerve damage causing muscle weakness): reported with oral dapsone; no cases were seen in topical dapsone clinical trials.
🔀What it interacts with▾

Dapsone can interact with several medicines — let your prescriber and pharmacist know everything you take.

  • Trimethoprim-sulfamethoxazole (TMP/SMX) — raises dapsone and its metabolite levels in the blood; increases hemolysis risk in people with G6PD deficiency when used with topical dapsone
  • Topical benzoyl peroxide — applying after dapsone gel may cause temporary yellow or orange discoloration of skin and facial hair
  • Rifampin, anticonvulsants (anti-seizure medicines), St. John's wort — may increase formation of a dapsone byproduct linked to hemolysis; relevant with oral dapsone
  • Pyrimethamine and other folic acid antagonists — increase the risk of blood cell problems with oral dapsone
  • Drugs that cause methemoglobinemia (e.g., benzocaine, chloroquine, nitrates, nitroglycerin, phenytoin, primaquine, sulfonamides) — combined use with dapsone raises the risk of methemoglobinemia
  • Oral dapsone or antimalarial medicines — should not be used at the same time as topical dapsone gel due to increased hemolysis risk

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy to dapsone: do not use if you are allergic to dapsone or its derivatives — this is a contraindication
  • G6PD deficiency: tell your doctor; you are at higher risk of hemolysis. This enzyme deficiency is more common in people of African, South Asian, Middle Eastern, or Mediterranean descent
  • Congenital or idiopathic methemoglobinemia: topical dapsone gel should be avoided if you have this condition
  • Pregnancy: no adequate human data exist for topical dapsone in pregnancy; animal studies at high oral doses showed harm. Discuss risks and benefits with your doctor
  • Breastfeeding: oral dapsone appears in breast milk and may cause hemolytic anemia in nursing infants, especially those with G6PD deficiency. Topical absorption is much lower, but discuss with your doctor
  • Children: Aczone Gel, 7.5% and dapsone gel are approved for acne in patients 9 and older. Safety and efficacy of dapsone gel, 5% was evaluated in children aged 12–17
  • Older adults: limited clinical trial data exist for topical dapsone in those 65 and over; use with care and discuss with your prescriber
  • Severe heart or lung disease: hemolysis and methemoglobin effects may be harder for these patients to tolerate; close monitoring is needed with oral dapsone
🚑If you take too much▾

Taking too much dapsone by mouth can cause nausea, vomiting, and unusual excitability within minutes to up to 24 hours. Severe cases may involve methemoglobinemia (causing dangerous low blood oxygen), convulsions, or severe blue-grey skin color — these require emergency treatment. If you suspect an overdose, seek emergency medical help immediately.

🔬Pharmacokinetics — how your body processes it▾

When dapsone gel, 7.5% is applied to the skin once daily, steady-state blood levels are reached within about 7 days. The amount of dapsone that enters the bloodstream from the topical gel is expected to be roughly 1% of what would be absorbed from an oral dose — meaning the systemic exposure is very low. Studies showed that age (12–15 vs. 16 and older), gender, and race did not meaningfully affect how the body handled topical dapsone, and exposure did not build up over a year of use.

📦How to store it▾

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 Dapsone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

215

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.

Severity mix
  • Major · 7
  • Moderate · 167
  • Minor · 41
ACTIVATED CHARCOAL Major BEER Major GRAPEFRUIT Major PARA-AMINOBENZOIC ACID (PABA) Major SIBERIAN COCKLEBUR Major ST. JOHN'S WORT Major WINE Major ACACIA RIGIDULA Moderate +207 more
Every supplement checked against Dapsone — ranked by severity The full interaction hub: 7 major · 167 moderate · 41 minor · every one linked to its full report. Check Dapsone against your exact supplements

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.

7

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.

Evidence & significance mix
  • Higher significance · 6
  • Moderate · 1
BIOTIN Insignificant Depletion FOLIC ACID Insignificant Depletion RIBOFLAVIN Insignificant Depletion THIAMINE Insignificant Depletion VITAMIN B12 Insignificant Depletion VITAMIN B6 Insignificant Depletion VITAMIN K Moderate Depletion
See the full Dapsone nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

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 actually used for? ▾
It depends on the form. The dapsone tablet is used to treat leprosy and a blistering, itchy skin condition called dermatitis herpetiformis. The topical gel — including Aczone Gel — is applied directly to the skin to treat acne vulgaris in people aged 9 and older. The gel is not used for leprosy or dermatitis herpetiformis — those require the tablet.
How do I use Aczone Gel correctly? ▾
Gently wash your face and pat it dry first. Then squeeze out about a pea-sized amount of Aczone Gel, 7.5% and apply a thin layer across your whole face once a day. You can also apply a thin layer to other affected areas. Rub it in gently and completely. It's for the skin only — not for your eyes, mouth, or anywhere internal. If your acne hasn't improved after 12 weeks, check back with your prescriber.
What side effects should I watch out for? ▾
With the gel, the most common ones are mild — some dryness, oiliness, peeling, or redness where you apply it. One thing to know: if you also use a benzoyl peroxide product, applying it after dapsone gel can cause a temporary yellow or orange tint on your skin or hair. That's harmless and goes away, but it can be surprising. With the oral tablet, the risks are more serious — blood problems and nerve effects are possible, so your doctor will monitor your blood regularly. Call your doctor right away if you notice bluish lips or nails, unusual tiredness, pale skin, sore throat, or fever.
I have a G6PD deficiency — is dapsone safe for me? ▾
G6PD deficiency does put you at higher risk of a side effect called hemolysis, where red blood cells break down faster than they should. Your doctor needs to know about this before you start. With the topical gel, the risk appears to be low, though some lab changes suggestive of hemolysis have been seen in studies. The oral tablet carries a more significant risk. Either way, your prescriber and pharmacist should know about your G6PD deficiency so they can monitor you appropriately and avoid combining dapsone with other drugs that add to that risk.
Are there medicines or products I need to avoid while using dapsone? ▾
Yes, a few important ones. TMP/SMX (a common antibiotic also called co-trimoxazole) can raise dapsone levels in your blood, and together they can increase the risk of blood problems — especially if you have G6PD deficiency. Antimalarial medicines and oral dapsone should not be used at the same time as the dapsone gel. Some drugs — like benzocaine, chloroquine, nitrates, or phenytoin — can compound dapsone's effect on blood oxygen. And if you use a benzoyl peroxide product on your skin, apply the dapsone gel first and expect possible temporary skin discoloration. Always give your doctor and pharmacist a full list of everything you take.
Can I use dapsone if I'm pregnant or breastfeeding? ▾
Talk to your doctor before using dapsone if you are pregnant, trying to become pregnant, or breastfeeding. There's no solid human safety data for topical dapsone during pregnancy, and high-dose oral dapsone caused harm in animal studies. Oral dapsone does pass into breast milk and could potentially cause blood problems in a nursing baby, especially one with G6PD deficiency. The topical gel gets into the bloodstream in much smaller amounts than the tablet, but the decision should still be made with your prescriber weighing the benefits and risks for you.
Is Dapsone available over the counter? ▾
Dapsone is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Dapsone first available? ▾
Dapsone has been available in the United States since at least 1979, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Dapsone? ▾
Dapsone is supplied by 51 manufacturers listed in the FDA NDC Directory, including Jacobus Pharmaceutical Company, Inc., Almirall, Llc, Golden State Medical Supply, Inc..

💬 Answers drafted from Dapsone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Dapsone supplement interactions215 checked — ranked by severity 🌿Drug & Supplement CheckerDapsone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Dapsone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Dapsone 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.

Tablet

By mouth
How this form is used
What it may be used for
  • Dapsone tablets treat dermatitis herpetiformis (a chronic blistering, itchy skin condition)
  • Dapsone tablets treat leprosy — all forms except those with proven dapsone resistance
Important instructions
  • Dapsone tablets are taken by mouth once daily; your prescriber will set and adjust your dose based on your response
  • For leprosy, Dapsone tablets must be taken continuously without interruption, in combination with other anti-leprosy medicines as directed
  • For dermatitis herpetiformis, dosage is adjusted individually — a gluten-free diet may reduce the amount needed over time
  • Do not stop or change your dose without talking to your prescriber first
Available strengths 2 strengths
25 mg 100 mg
55 FDA-listed product records ⓘ

Topical cream, ointment or gel

On the skin
Brands Aczone
How this form is used
What it may be used for
  • Aczone Gel, 7.5% is used for the topical treatment of acne vulgaris in patients 9 years of age and older
  • Dapsone gel is used for the topical treatment of acne vulgaris in patients 9 years of age and older
Important instructions
  • Aczone Gel, 7.5%: gently wash and pat dry the skin, then apply 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
  • Aczone Gel, 7.5%: rub in gently and completely; for topical use only — do not use on eyes, by mouth, or vaginally
  • Dapsone gel, 5%: apply a pea-sized amount in a thin layer to acne-affected areas twice daily; wash hands after application
  • If there is no improvement after 12 weeks, check with your prescriber about whether to continue treatment
Available strengths 2 strengths
50 mg/g 75 mg/g
40 FDA-listed product records ⓘ

📊 Dapsone across the U.S. market

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.

2
Dose forms ⓘ
51
Manufacturers
6
Brand names
113
FDA-listed product records ⓘ
1979
First marketed ⓘ

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 (18) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Jacobus Pharmaceutical Company, Inc.6%
Almirall, Llc5%
Golden State Medical Supply, Inc.5%
Taro Pharmaceuticals U.S.A., Inc.4%
Westminster Pharmaceuticals, LLC4%
ANI Pharmaceuticals, Inc.4%
Other makers73%

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

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.

42,610
Medicaid prescriptions filled (Q1–Q4 2025)
$3.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Dapsone prescribed? Of the 1,596 medications we measure, Dapsone ranks #663 by Medicaid prescriptions — more than 58% of them.

Where Dapsone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #663 of 1,596
#658 Tenapanor 43,479 Rx #659 Etodolac 43,348 Rx #660 Ofatumumab Injection (... 43,282 Rx #661 Ofatumumab Injection (... 43,282 Rx #662 Albendazole 43,095 Rx #663 Dapsone 42,610 Rx #664 Tezepelumab Injection 42,607 Rx #665 Dornase Alfa 42,474 Rx #666 Atenolol / Chlorthalid... 42,330 Rx #667 Ivabradine 42,299 Rx #668 Prucalopride 42,108 Rx

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.

The 0.05 mg/mg topical gel is the most-dispensed Dapsone product — about 32% of these Medicaid prescriptions.

dapsone 0.05 MG/MG Topical Gel Most dispensed

13,496 Medicaid prescriptions (Q1–Q4 2025) 32% of Dapsone prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $106 per prescription (gross)

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

12,957 Medicaid prescriptions (Q1–Q4 2025) 30% of Dapsone prescriptions shown $505,811 gross reimbursement (before rebates) ≈ $39 per prescription (gross)

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

11,074 Medicaid prescriptions (Q1–Q4 2025) 26% of Dapsone prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $115 per prescription (gross)

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

5,083 Medicaid prescriptions (Q1–Q4 2025) 12% of Dapsone prescriptions shown $233,975 gross reimbursement (before rebates) ≈ $46 per prescription (gross)

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.)

Showing 113 of 113 products — FDA National Drug Code Directory. See every product, package size and price: browse all 113 Dapsone NDCs →

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.

Ingredient (IN) Dapsone RxCUI 3108 2 dose forms · 5 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 371689 In current FDA listings
    Clinical drug / strength (SCD) 25 MG RxCUI 197558 50 MG RxCUI 105297 100 MG RxCUI 197557
  2. Dose form (SCDF) Topical Gel RxCUI 607294 In current FDA listings
    Clinical drug / strength (SCD) 0.05 MG/MG RxCUI 607295 0.075 MG/MG RxCUI 1741905

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.

🏷️ Sold under these brand names

Aczone

🏭 Manufacturers & labelers

Jacobus Pharmaceutical Company, Inc. 6 Almirall, Llc 5 Golden State Medical Supply, Inc. 5 Taro Pharmaceuticals U.S.A., Inc. 4 Westminster Pharmaceuticals, LLC 4 ANI Pharmaceuticals, Inc. 4 Rising Pharma Holdings, Inc. 4 Northstar Rx Llc 4 Sun Pharmaceutical Industries, Inc. 4 Nostrum Laboratories, Inc. 4 Pacific Pharma, Inc. 3 Zydus Lifesciences Limited 3 Torrent Pharmaceuticals Limited 3 Professional Compounding Centers of America dba PCCA 3 Viona Pharmaceuticals Inc 3 Allergan, Inc. 3 Alembic Pharmaceuticals Inc. 3 Mayne Pharma Commercial LLC 2 Macleods Pharmaceuticals Limited 2 Seton Pharmaceuticals 2 Mylan Pharmaceuticals Inc. 2 Novitium Pharma LLC 2 Proficient Rx LP 2 Solis Pharmaceuticals Inc. 2

…and 16 more on the FDA NDC directory.

RxNorm drug class

Dapsone belongs to the Sulfone class.

Pharmacologic class Sulfone
Drug family (ATC) Other anti-acne preparations for topical use, Drugs for treatment of lepra

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.

🔬 Where this comes from

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 28, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Dapsone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Dapsone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
19
NDC products indexed
113
Distinct labelers/manufacturers represented
51
Linked representative label ⓘ
Westminster Pharmaceuticals, LLC
Linked label effective
Aug 28, 2025
Composite sections available
17
Linked SPL Set ID
7d317576-5edd-4c27-a00d-68b5944c04a8
Linked SPL Document ID
94a7ec84-91fc-4cb2-9ddc-49e82e94408f
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 19 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Westminster Pharmaceuticals, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.