Quick answers
- What is Calcipotriene used for?
- The FDA-approved label (Sorilux, Mayne Pharma, May 9, 2024) says: “SORILUX Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. SORILUX ® Foam is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Calcipotriene have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Calcipotriene?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Calcipotriene been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started January 19, 2017 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Calcipotriene?
- 7 companies list prescription products of Calcipotriene in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc., Glenmark Pharmaceuticals Inc., USA and Mayne Pharma.
What Calcipotriene is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SORILUX Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. SORILUX ® Foam is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older.
— FDA label: Sorilux, Mayne Pharma, effective May 9, 2024. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| calcipotriene 0.05 mg/mL solution | Generic | $2.72 per mL |
| calcipotriene 50 ug/g cream | Generic | $1.03–$1.06 per gram 6 packages, lowest to highest |
| calcipotriene 50 ug/g ointment | Generic | $2.00–$2.32 per gram 4 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sun Pharmaceutical Industries, Inc.2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Mayne Pharma2 products
- Prasco Laboratories2 products
- Perfero Pharma, Inc.1 product
- NorthStar Rx LLC1 product
- Cosette Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020273 DOVONEX | Leo Pharma As | December 29, 1993 | 12, latest October 3, 2025 2025: Labeling · 2015: Labeling · 2014: Manufacturing (CMC) |
| NDA020554 DOVONEX | Leo Pharma As | July 22, 1996 | 11, latest October 3, 2025 2025: Labeling · 2015: Labeling · 2014: Manufacturing (CMC) |
| NDA022563 SORILUX | Mayne Pharma | October 6, 2010 | 6, latest November 5, 2019 2019: Labeling · 2019: Efficacy · 2019: Efficacy |
Generic approvals (3)
- ANDA090633Glenmark Pharms · March 24, 2010
- ANDA078468Cosette Pharms Nc · March 24, 2011
- ANDA205772Glenmark Speclt · June 9, 2015
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 19, 2017 · Class II · Terminated · D-0510-2017
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 450 — LEO PHARMA INC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sorilux, Mayne Pharma, effective May 9, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →