Quick answers
- What is Desloratadine and pseudoephedrine sulfate used for?
- The FDA-approved label (Clarinex-D 12 Hour, Organon LLC, November 12, 2025) says: “CLARINEX-D 12 HOUR is a combination product containing a histamine-1 (H1) receptor antagonist and an alpha adrenergic agonist indicated for: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 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 Desloratadine and pseudoephedrine sulfate have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Desloratadine and pseudoephedrine sulfate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Desloratadine and pseudoephedrine sulfate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Desloratadine and pseudoephedrine sulfate?
- 1 company lists prescription products of Desloratadine and pseudoephedrine sulfate in the FDA NDC Directory, including Organon LLC.
What Desloratadine and pseudoephedrine sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CLARINEX-D 12 HOUR is a combination product containing a histamine-1 (H1) receptor antagonist and an alpha adrenergic agonist indicated for: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. …
— FDA label: Clarinex-D 12 Hour, Organon LLC, effective November 12, 2025. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Tablet, extended release |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Clarinex-D 12 Hour |
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 2.5 mg · pseudoephedrine sulfate 120 mg tablet, extended release | Brand: Clarinex-D 12 Hour | $6.06 per tablet |
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.
- Organon LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021313 CLARINEX-D 12 HOUR | Organon LLC | February 1, 2006 | 7, latest March 15, 2019 2019: Labeling · 2018: Labeling · 2018: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1112248, 1112250 |
|---|---|
| SPL set ID of the quoted label | 1af66b7a-4ab8-40d8-abdd-22d3310228a8 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA021313 |
| Active ingredients (FDA) | DESLORATADINE / PSEUDOEPHEDRINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Clarinex-D 12 Hour, Organon LLC, effective November 12, 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 →