Quick answers
- What is Desloratadine used for?
- The FDA-approved label (Clarinex, Organon LLC, May 17, 2025) says: “CLARINEX is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. Chronic Idiopathic Urticaria …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Desloratadine have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Desloratadine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Desloratadine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started December 20, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Desloratadine?
- 10 companies list prescription products of Desloratadine in the FDA NDC Directory, including A-S Medication Solutions, Dr. Reddy's Laboratories Limited and Bryant Ranch Prepack.
What Desloratadine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CLARINEX is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. Chronic Idiopathic Urticaria …
— FDA label: Clarinex, Organon LLC, effective May 17, 2025. Read the full label on DailyMed →
The FDA has 13 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 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Tablet, orally disintegrating · Solution |
|---|---|
| Route | Oral |
| Prescription products | 15 in the FDA NDC Directory |
| Brand names | Clarinex |
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 |
|---|---|---|
| desloratadine 5 mg tablet, film coated | Generic | $0.2557 per tablet |
| desloratadine 5 mg tablet, film coated | Brand: Clarinex | $8.85 per tablet |
| desloratadine 5 mg tablet, orally disintegrating | Generic | $4.74 per tablet |
NADAC list of November 4, 2026; these prices took effect between February 18, 2026 and 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.
- A-S Medication Solutions3 products
- Dr. Reddy's Laboratories Limited2 products
- Bryant Ranch Prepack2 products
- Organon LLC2 products
- Natco Pharma USA LLC1 product
- Lupin Pharmaceuticals, Inc.1 product
- INA Pharmaceutics Inc1 product
- Virtus Pharmaceuticals, LLC1 product
- Morepen Bio Inc.1 product
- Bionpharma 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 |
|---|---|---|---|
| NDA021165 CLARINEX | Organon | December 21, 2001 | 12, latest March 15, 2019 2019: Labeling · 2019: Labeling · 2016: Manufacturing (CMC) |
Generic approvals (6)
- ANDA078357Orbion Pharms · February 19, 2010
- ANDA078367Reddys · July 12, 2010
- ANDA078352Lupin Pharms · October 25, 2010
- ANDA078351Natco Pharma USA · February 10, 2012
- ANDA078355Ajenat Pharms · April 19, 2012
- ANDA202936Taro · May 26, 2016
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.
-
December 20, 2023 · Class II · Terminated · D-0221-2024
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202. — Lupin Pharmaceuticals 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) — Clarinex, Organon LLC, effective May 17, 2025; 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 →