FDA-filed SPL labeling · retrieved through openFDA

Betamethasone / Calcipotriene

Betamethasone / calcipotriene is a prescription topical combination of a corticosteroid and a vitamin D analog used to treat plaque psoriasis across several formulations including foam, ointment, cream, and suspension products.

Brand names TaclonexWynzoraEnstilarAttero
Drug classes ⓘ Corticosteroid
Rx Forms 4 Route 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 11 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 effectiveNov 30, 2017
Clinical labels in scope ⓘ11
AvailabilityRx
Earliest approval/marketing year ⓘ2008
FDA-listed product records ⓘ31
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 27, 2026
⭐ Betamethasone / Calcipotriene at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Betamethasone / calcipotriene is an effective topical combination used to treat plaque psoriasis, with products approved for patients as young as 12. Use it only as directed — on the affected areas, once daily, for the shortest time needed — and stop when your psoriasis clears. Watch for signs of high calcium or adrenal suppression, and keep all follow-up appointments so your doctor can monitor for these risks.
How we write & review this content — our editorial policy →

📖 Betamethasone / Calcipotriene: Patient Information Guide

A plain-language walkthrough of Betamethasone / Calcipotriene — 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▾

Betamethasone / calcipotriene is a topical combination product used to treat plaque psoriasis. Specific approvals vary by product, formulation, and patient age:

  • Enstilar Foam: Plaque psoriasis in patients 12 years and older
  • Calcipotriene and Betamethasone Dipropionate Ointment: Plaque psoriasis in patients 12 years and older
  • Taclonex Topical Suspension: Plaque psoriasis of the scalp and body in patients 12 years and older
  • Calcipotriene and betamethasone dipropionate topical suspension (generic): Plaque psoriasis of the scalp in patients 12 and older; plaque psoriasis of the scalp and body in patients 18 and older
  • Attero Topical Suspension: Plaque psoriasis of the scalp in patients 12 and older; plaque psoriasis of the scalp and body in patients 18 and older
  • Wynzora Cream: Plaque psoriasis in patients 18 years and older
⚙️How it works▾

This product combines two ingredients that attack plaque psoriasis from different angles. Betamethasone dipropionate is a potent synthetic corticosteroid — it dials down the skin inflammation, redness, and itch that make psoriasis plaques so uncomfortable. Calcipotriene is a synthetic vitamin D analog that helps normalize the rapid, out-of-control skin cell turnover that creates those thick, scaly plaques. Together they address both the inflammatory and the proliferative (overgrowth) sides of psoriasis, though the precise mechanism of their combined action on the skin is not fully understood.

💊How it's taken▾

All forms are applied to the skin once daily. Foam and ointment formulations are generally used for up to 4 weeks. Suspension and cream formulations are generally used for up to 8 weeks. Stop treatment once your skin is under control — don't continue beyond what your prescriber recommends.

  • Always wash your hands after applying any formulation
  • Suspensions: shake the bottle well before each use; do not bathe or wash your hair right after applying to the scalp
  • Foam: shake the can before use and rub in gently
  • Avoid the face, groin, and underarm areas with all formulations
  • Do not use occlusive (airtight) dressings over treated areas unless your doctor specifically tells you to
🤒Side effects — in detail▾

The most commonly reported side effects include:

  • Itching (pruritus) — the most frequently reported reaction
  • Scaly rash near treated areas
  • Headache
  • Skin redness (erythema)
  • Burning or stinging on the skin
  • Folliculitis (inflamed hair follicles)
  • Skin thinning (atrophy), especially with prolonged use
  • Skin color changes (hypopigmentation or hyperpigmentation)

More serious reactions — including signs of high calcium, adrenal suppression, eye problems, or a worsening/pustular flare of psoriasis — require prompt medical attention. See the warnings section for details.

⚠️Warnings & precautions▾

The two most important risks to know about are high calcium levels and adrenal suppression. The calcipotriene component can raise calcium in the blood or urine (hypercalcemia/hypercalciuria). If this happens, your doctor will stop treatment until levels normalize. The betamethasone component can suppress the HPA axis — the body's system for managing stress hormones — especially when applied to large areas, used for a long time, or used under coverings. Children ages 12–17 are at higher risk because they absorb more through the skin relative to their body size.

  • Cushing's syndrome and high blood sugar: Rare, but possible with excessive or prolonged corticosteroid absorption
  • Eye risks: Avoid contact with eyes; topical corticosteroids can increase the risk of cataracts and glaucoma
  • Allergic contact dermatitis: May occur with either ingredient — a sign is the skin not improving or getting worse rather than better
  • Rebound effect: Psoriasis may flare after stopping; do not stop abruptly without guidance if you have been using it long-term
🔀What it interacts with▾

The FDA label for betamethasone / calcipotriene does not list specific drug-drug interactions; however, there are important use-related cautions to keep in mind:

  • Other corticosteroid-containing products: Using more than one steroid product at the same time increases total systemic corticosteroid exposure and the risk of adrenal suppression — tell your doctor about all topical products you use
  • Occlusive dressings or bandages: Covering treated skin tightly increases absorption of both ingredients, raising the risk of systemic side effects
  • Chemical hair treatments: For scalp suspensions, do not apply within 12 hours before or after any chemical treatments to the hair

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▾
  • Pregnant women: Use the smallest amount for the shortest time possible; large amounts of potent topical corticosteroids have been linked to low birth weight in infants
  • Breastfeeding women: Do not apply to the nipple or areola; use on the smallest area possible for the shortest time
  • Children and adolescents (12–17 years): Approved for some formulations but at higher risk for HPA axis suppression and other systemic effects — weekly dose limits apply
  • Children under 12: Safety and effectiveness have not been established for most products
  • People with liver disease: Impaired liver function is a risk factor for greater systemic absorption of corticosteroids
  • Anyone with skin atrophy (thinning skin) at the site: Do not apply to already-thinned skin
  • People using multiple corticosteroid products: Inform your doctor to avoid excess total steroid exposure
🚑If you take too much▾

Although this medication is applied to the skin, it can be absorbed into the body in amounts large enough to cause systemic effects if used excessively. Overuse may lead to high calcium levels or suppression of the adrenal glands. If you think you or someone else has used too much, contact your doctor or poison control right away.

📡Pharmacodynamics — effects in the body▾

Betamethasone dipropionate is classified as a potent corticosteroid — a vasoconstrictor study in healthy subjects showed skin blanching consistent with potent corticosteroid activity when compared to other topical steroids. However, similar blanching scores do not necessarily mean two products work equally well therapeutically. Clinical trials demonstrated that the combination can suppress the HPA axis (the body's adrenal hormone system) in some patients, with rates varying based on the treatment area, duration, and patient age. The calcipotriene component has also shown the potential to affect calcium metabolism, with elevated urinary calcium observed in some study participants.

🔬Pharmacokinetics — how your body processes it▾

When applied to the skin, calcipotriene and betamethasone dipropionate themselves are largely not detectable in the bloodstream at typical doses — but their breakdown products (metabolites) can be. Calcipotriene is rapidly metabolized in the liver into less active compounds, with MC1080 being the main metabolite found in plasma. Betamethasone dipropionate is broken down to betamethasone 17-propionate (B17P) as its primary metabolite. The clinical significance of these circulating metabolite levels is not fully known. The amount absorbed depends on skin condition, treatment area size, duration of use, and whether the area is covered.

📦How to store it▾

Store Enstilar Foam at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F). store at temperatures above 120°F (49°C). Do not freeze.

📄 Written from Betamethasone / Calcipotriene’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 →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Betamethasone / Calcipotriene — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is this medication supposed to do for my psoriasis? ▾
It works on two fronts at once. The betamethasone part is a strong steroid that calms down the inflammation causing your redness and itch. The calcipotriene part is a form of vitamin D that slows down the rapid skin cell buildup that creates those thick, scaly patches. Together they can clear or significantly improve plaque psoriasis. Most people are used for a set number of weeks — usually 4 to 8 depending on the product — and then stop once the skin is under control.
How do I apply this correctly — is there anything I should know before I start? ▾
Apply it to the affected areas once daily, rub it in gently, and always wash your hands after. If you're using a suspension or solution for your scalp, shake the bottle first and don't wash your hair or shower right after applying. If you're using the foam, shake the can first. Never apply it to your face, groin, or underarms — only to the areas your doctor specified. And don't cover the treated skin with tight or airtight bandages unless your doctor tells you to, since that can increase how much gets absorbed.
What side effects should I expect, and which ones mean I need to call my doctor? ▾
The most common side effects are itching, a scaly rash near the treated area, and sometimes some skin redness or burning — these are usually mild. Call your doctor if you notice symptoms that might suggest too much calcium in your system, like unusual weakness, nausea, or increased thirst and urination. Also reach out if you feel unusually tired or dizzy, especially after stopping the medication — that could be a sign of adrenal suppression. And if you notice vision changes, contact your doctor, since this medication can raise the risk of cataracts and glaucoma if it gets near your eyes.
Is it safe to use if I'm pregnant or breastfeeding? ▾
Talk to your doctor before using it if you're pregnant. Using large amounts of potent topical steroids during pregnancy has been linked to lower birth weight in babies. The guidance is to use the smallest amount on the smallest area for the shortest time needed. If you're breastfeeding, avoid applying it to the nipple or areola area to keep the baby from being exposed through skin contact. Your doctor can help you weigh the benefits and risks for your specific situation.
My child is 14 — can they use this medication? ▾
Some formulations are approved for patients 12 and older, so it may be appropriate — but teens need extra monitoring. Kids and teenagers absorb more of the medication through their skin relative to their body size, which means they're at higher risk for side effects like adrenal suppression. There are also weekly quantity limits for patients aged 12 to 17 that are lower than for adults. Make sure the prescribing doctor knows your child's age and is overseeing treatment carefully.
How long will I need to use this, and can I stop whenever I want? ▾
Most products are intended for short-term use — typically 4 to 8 weeks depending on the formulation — and you should stop once your psoriasis is under control. Don't use it longer than directed just to prevent flares; that increases the risk of side effects like skin thinning and adrenal effects. If your psoriasis comes back after stopping, check back in with your doctor rather than restarting on your own.
Is Betamethasone / Calcipotriene available over the counter? ▾
Betamethasone / Calcipotriene 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 Betamethasone / Calcipotriene first available? ▾
Betamethasone / Calcipotriene has been available in the United States since at least 2008, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Betamethasone / Calcipotriene? ▾
Betamethasone / Calcipotriene is supplied by 12 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Padagis Israel Pharmaceuticals Ltd, LEO Pharma Inc..

💬 Answers drafted from Betamethasone / Calcipotriene’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

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💊 How Betamethasone / Calcipotriene comes

Betamethasone / Calcipotriene is available in 4 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.

Topical cream, ointment or gel

On the skin
Brands Taclonex Wynzora
How this form is used
What it may be used for
  • Calcipotriene and Betamethasone Dipropionate Ointment is used for plaque psoriasis in patients 12 years and older
  • Wynzora Cream is used for plaque psoriasis in patients 18 years and older
Important instructions
  • Calcipotriene and Betamethasone Dipropionate Ointment: Apply once daily for up to 4 weeks; adults should not use more than 100 g per week, and patients 12–17 should not use more than 60 g per week
  • Calcipotriene and Betamethasone Dipropionate Ointment: Rub in gently; avoid the face, groin, and underarms; do not treat more than 30% of body surface area
  • Wynzora Cream: Apply once daily for up to 8 weeks; do not use more than 100 g per week
  • Wynzora Cream: Rub in gently to saturate the plaques; do not use on the face, groin, or underarms or with occlusive dressings unless directed
Available strengths 6 strengths
50 mcg/g / 0.643 mg/g 50 mcg/g / 64 mg/g 50 mcg/g / 0.5 mg/g 0.5 mg/g / 50 mcg/g 0.643 mg/g / 50 mcg/g 64 mg/g / 50 mcg/g
16 FDA-listed product records ⓘ

Topical suspension

On the skin
Brands Taclonex
How this form is used
What it may be used for
  • Taclonex Topical Suspension is used for plaque psoriasis of the scalp and body in patients 12 years and older
  • Calcipotriene and betamethasone dipropionate topical suspension is used for plaque psoriasis of the scalp in patients 12 and older, and plaque psoriasis of the scalp and body in patients 18 and older
Important instructions
  • Taclonex and calcipotriene and betamethasone dipropionate suspension: Shake bottle before each use
  • Apply to affected scalp and body areas once daily for up to 8 weeks; patients 12–17 should not use more than 60 g per week; adults should not use more than 100 g per week
  • Wash hands after applying; do not bathe, shower, or wash hair immediately after application
  • Do not apply to the scalp within 12 hours before or after chemical hair treatments; avoid the face, groin, and underarms
Available strengths 4 strengths
50 mcg/g / 50 mg/g 50 mcg/g / 0.5 mg/g 0.5 mg/g / 50 mcg/g 50 mg/g / 50 mcg/g
13 FDA-listed product records ⓘ

Inhaler

On the skin
Brands Enstilar
How this form is used
What it may be used for
  • Enstilar Foam is used for the topical treatment of plaque psoriasis in patients 12 years and older
Important instructions
  • Enstilar: Shake the can before each use
  • Enstilar: Apply to affected areas once daily for up to 4 weeks; do not exceed 60 grams every 4 days
  • Enstilar: Rub in gently and wash hands after applying
  • Enstilar: Do not use on the face, groin, or underarms, and do not use with occlusive dressings unless directed by your provider
Available strengths 1 strength
50 mcg/g / 0.5 mg/g
1 FDA-listed product record ⓘ

Topical solution

On the skin
Brands Attero
How this form is used
What it may be used for
  • Attero is used for plaque psoriasis of the scalp in patients 12 years and older
  • Attero is used for plaque psoriasis of the scalp and body in patients 18 years and older
Important instructions
  • Attero: Shake the bottle before each use
  • Attero: Apply to affected areas on the scalp and body once daily for up to 8 weeks; patients 12–17 should not use more than 60 g per week; adults should not use more than 100 g per week
  • Attero: Wash hands after applying; do not bathe, shower, or wash your hair right after application
  • Attero: Do not apply to the scalp within 12 hours before or after chemical hair treatments
Available strengths 1 strength
0.05 mg/g / 0.5 mg/g
1 FDA-listed product record ⓘ

📊 Betamethasone / Calcipotriene across the U.S. market

How Betamethasone / Calcipotriene 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.

4
Dose forms ⓘ
12
Manufacturers
5
Brand names
31
FDA-listed product records ⓘ
2008
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.

Bryant Ranch Prepack32%
Padagis Israel Pharmaceuticals Ltd16%
LEO Pharma Inc.10%
Prasco Laboratories10%
TOLMAR Inc.6%
MC2 Therapeutics Ltd6%
Other makers19%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Betamethasone / Calcipotriene is used

A general measure of how commonly Betamethasone / Calcipotriene 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 Betamethasone / Calcipotriene 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.

4,570
Medicaid prescriptions filled (Q1–Q4 2025)
$3.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Betamethasone / Calcipotriene prescribed? Of the 1,597 medications we measure, Betamethasone / Calcipotriene ranks #1,058 by Medicaid prescriptions — more than 34% of them.

Where Betamethasone / Calcipotriene ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,058 of 1,597
#1,053 Rifapentine 4,737 Rx #1,054 Dronabinol 4,723 Rx #1,055 Trofinetide 4,625 Rx #1,056 Pilocarpine Ophthalmic 4,597 Rx #1,057 Malathion Topical 4,594 Rx #1,058 Betamethasone / Calcip... 4,570 Rx #1,059 Terbutaline 4,509 Rx #1,060 Docosanol 4,506 Rx #1,061 Tolmetin 4,475 Rx #1,062 Letermovir 4,462 Rx #1,063 Fidaxomicin 4,446 Rx

Utilization by Betamethasone / Calcipotriene 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 0.0005 mg/mg / 0.00005 mg/mg topical ointment is the most-dispensed Betamethasone / Calcipotriene product — about 53% of these Medicaid prescriptions.

betamethasone 0.0005 MG/MG / calcipotriene 0.00005 MG/MG Topical Ointment Most dispensed

2,444 Medicaid prescriptions (Q1–Q4 2025) 53% of Betamethasone / Calcipotriene prescriptions shown $940,261 gross reimbursement (before rebates) ≈ $385 per prescription (gross)

Summed across the 4 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 388525

betamethasone dipropionate 0.643 MG/ML / calcipotriene 0.05 MG/ML Topical Foam

1,063 Medicaid prescriptions (Q1–Q4 2025) 23% of Betamethasone / Calcipotriene prescriptions shown $1.6M gross reimbursement (before rebates) ≈ $1,461 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1716094

betamethasone 0.5 MG/ML / calcipotriene 0.05 MG/ML Topical Lotion

1,063 Medicaid prescriptions (Q1–Q4 2025) 23% of Betamethasone / Calcipotriene prescriptions shown $643,033 gross reimbursement (before rebates) ≈ $605 per prescription (gross)

Summed across the 6 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 833461

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 Betamethasone / Calcipotriene, 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 12 of 28 listed Betamethasone / Calcipotriene NDCs with Medicaid activity.

🔍 Compare Betamethasone / Calcipotriene products

A representative set of FDA-listed product records for Betamethasone / Calcipotriene — 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 31 of 31 products — FDA National Drug Code Directory. See every product, package size and price: browse all 31 Betamethasone / Calcipotriene NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Betamethasone / Calcipotriene RxCUI 690419 4 dose forms · 4 strengths

Look up RxCUI 690419 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

Taclonex Wynzora Enstilar Attero

🏭 Manufacturers & labelers

Bryant Ranch Prepack 10 Padagis Israel Pharmaceuticals Ltd 5 LEO Pharma Inc. 3 Prasco Laboratories 3 TOLMAR Inc. 2 MC2 Therapeutics Ltd 2 Sandoz Inc. 1 LEO Pharma Inc 1 Taro Pharmaceuticals U.S.A., Inc. 1 Perfero Pharma, Inc. 1 Cosette Pharmaceuticals, Inc. 1 Sun Pharmaceutical Industries, Inc. 1

RxNorm drug class

Betamethasone / Calcipotriene belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Corticosteroids, Corticosteroids, potent (group III)
How it works Corticosteroid Hormone Receptor Agonists

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 Nov 30, 2017
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Betamethasone / Calcipotriene.
📈
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 Betamethasone / Calcipotriene after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
11
NDC products indexed
31
Distinct labelers/manufacturers represented
12
Linked representative label ⓘ
LEO Pharma Inc.
Linked label effective
Nov 30, 2017
Composite sections available
22
Linked SPL Set ID
757c914f-dd8d-43cc-a973-212d591af4af
Linked SPL Document ID
5d56e57e-6b91-4916-96d8-6dca1af7487d
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 11 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. LEO Pharma Inc. 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.