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Desloratadine

Desloratadine is a once-daily antihistamine used to relieve seasonal and year-round allergic rhinitis (nasal allergy) symptoms and to treat chronic idiopathic urticaria (long-lasting hives with no known cause).

Brand names ClarinexClarinex Reditabs
Drug class Histamine-1 Receptor Antagonist
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 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 14 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 →

✓No current FDA shortage listed · checked Oct 7, 2026
Desloratadine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Desloratadine (Clarinex) is a once-daily antihistamine for seasonal and year-round nasal allergies (allergic rhinitis) and chronic hives with no known cause, blocking histamine, the body's allergy signal; it is the active form of loratadine (Claritin), on the U.S. market since about 2001 and available as a generic. Most people tolerate it well and usually notice little beyond dry mouth, a sore throat, tiredness or headache, with less drowsiness than older antihistamines. Stop it and get help right away for signs of a serious allergic reaction, such as swelling or trouble breathing. With liver or kidney problems, tell your prescriber, since you may need to take it less often.

Clinical pearls

  • If loratadine (Claritin) ever gave you an allergic reaction, avoid desloratadine too, since it is loratadine's active form.
  • Food and grapefruit juice do not change how much you absorb, so take it whenever in the day is easiest to remember.
  • The orally disintegrating tablet (Clarinex Reditabs) dissolves on the tongue, a handy option for anyone who struggles to swallow tablets.
  • Desloratadine needs a prescription, but its close relative loratadine is sold over the counter, often for less.
How you get itPrescription only
Comes asTablet, Orally disintegrating tablet, Oral solution
Earliest FDA record2001
Companies listing it with the FDA10
FDA label last updatedMay 17, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Desloratadine, written from its FDA label.

What Desloratadine is used for

▾

Desloratadine treats allergy-related conditions. Supported uses include:

  • Seasonal allergic rhinitis: relief of nasal and non-nasal symptoms (age 2 and older for Clarinex, desloratadine oral solution and desloratadine orally disintegrating tablets; age 12 and older for Desloratadine Tablets).
  • Perennial allergic rhinitis: relief of nasal and non-nasal symptoms (age 6 months and older for Clarinex, oral solution and orally disintegrating tablets; age 12 and older for Desloratadine Tablets).
  • Chronic idiopathic urticaria: relief of itching and fewer, smaller hives (age 6 months and older for Clarinex, oral solution and orally disintegrating tablets; age 12 and older for Desloratadine Tablets).

How Desloratadine works

▾

Desloratadine is a long-acting antihistamine that selectively blocks histamine H1 receptors. Histamine drives allergy symptoms such as sneezing, runny nose, itching and hives. Blocking its receptor reduces those symptoms.

In lab studies, desloratadine also reduced histamine release from human mast cells. Animal studies suggested it does not readily cross the blood-brain barrier, though the clinical significance is unknown.

Desloratadine dosage

▾

Desloratadine is taken by mouth once a day, with or without food. Products differ in form and age range.

  • Tablets: swallowed once daily.
  • Orally disintegrating tablets: placed on the tongue to dissolve, with or without water, taken right after opening the blister.
  • Oral solution: measured with a dropper or syringe; the amount depends on age.

Adults with liver or kidney impairment may be started on a less frequent schedule. Follow your prescriber and the product label.

Dosing details from the FDA-approved label

From the Desloratadine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adults and Adolescents 12 Years of Age and Over
    • Tablets or RediTabs/orally disintegrating tablets: one 5 mg tablet once daily
    • Oral Solution: 2 teaspoonfuls (5 mg in 10 mL) once daily
    • May be taken without regard to meals
  • Children 6 to 11 Years of Age
    • Oral Solution: 1 teaspoonful (2.5 mg in 5 mL) once daily
    • RediTabs/orally disintegrating tablets: one 2.5 mg tablet once daily
    • May be taken without regard to meals
  • Children 12 Months to 5 Years of Age
    • Oral Solution: ½ teaspoonful (1.25 mg in 2.5 mL) once daily
    • Orally disintegrating tablets are not recommended under 6 years of age
  • Children 6 to 11 Months of Age
    • Oral Solution: 2 mL (1 mg) once daily
  • Adults with Hepatic or Renal Impairment
    • Starting dose of one 5 mg tablet every other day
    • Based on pharmacokinetic data; dosing recommendation for children with liver or renal impairment cannot be made due to lack of data
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Although the oral solution and the orally disintegrating tablet formulation of desloratadine may be available in the marketplace, CLARINEX ® Oral Solution and CLARINEX ® RediTabs ® Tablets are no longer marketed. CLARINEX Tablets, Oral Solution, or RediTabs Tablets may be taken without regard to meals. Place CLARINEX (desloratadine) RediTabs Tablets on the tongue and allow to disintegrate before swallowing. Tablet disintegration occurs rapidly. Administer with or without water. Take tablet immediately after opening the blister. The age-appropriate dose of CLARINEX Oral Solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoon) . Dosage (by age): Adults and Adolescents 12 Years of Age and Over: CLARINEX Tablets - one 5 mg tablet once daily or CLARINEX RediTabs Tablets - one 5 mg tablet once daily or CLARINEX Oral Solution - 2 teaspoonfuls (5 mg in 10 mL) once daily ( 2 ) Children 6 to 11 Years of Age: CLARINEX Oral Solution - 1 teaspoonful (2.5 mg in 5 mL) once daily or CLARINEX RediTabs Tablets - one 2.5 mg tablet once daily ( 2 ) Children 12 Months to 5 Years of Age: CLARINEX Oral Solution - ½ teaspoonful (1.25 mg in 2.5 mL) once daily ( 2 ) Children 6 to 11 Months of Age: CLARINEX Oral Solution - 2 mL (1 mg) once daily ( 2 ) 2.1 Adults and Adolescents 12 Years of Age and Over The recommended dose of CLARINEX Tablets or CLARINEX RediTabs Tablets is one 5-mg tablet once daily. The recommended dose of CLARINEX Oral Solution is 2 teaspoonfuls (5 mg in 10 mL) once daily. 2.2 Children 6 to 11 Years of Age The recommended dose of CLARINEX Oral Solution is 1 teaspoonful (2.5 mg in 5 mL) once daily. The recommended dose of CLARINEX RediTabs Tablets is one 2.5-mg tablet once daily. 2.3 Children 12 Months to 5 Years of Age The recommended dose of CLARINEX Oral Solution is ½ teaspoonful (1.25 mg in 2.5 mL) once daily. 2.4 Children 6 to 11 Months of Age The recommended dose of CLARINEX Oral Solution is 2 mL (1 mg) once daily. 2.5 Adults with Hepatic or Renal Impairment In adult patients with liver or renal impairment, a starting dose of one 5-mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3) ].

Read the full Dosage and Administration section on DailyMed →

Desloratadine side effects

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In studies of adults and adolescents with allergic rhinitis, side effects were mostly similar to placebo. The more common ones were:

Common side effects

  • Sore throat (pharyngitis)
  • Dry mouth
  • Muscle aches (myalgia)
  • Tiredness (fatigue)
  • Sleepiness (somnolence)
  • Painful periods (dysmenorrhea)
  • Headache, nausea and dizziness (reported in hives studies)

When to get medical help

  • Stop the medicine and get medical help right away for signs of an allergic reaction: rash, itching, hives, swelling, trouble breathing or anaphylaxis.
  • Call your doctor about a racing or pounding heartbeat (tachycardia or palpitations).
  • Call your doctor about seizures or unusual movements such as tics or muscle spasms (dystonia).
  • Call your doctor about signs of liver problems; elevated liver enzymes and hepatitis have been reported.

In people with chronic hives, headache, nausea, dizziness and indigestion were also reported. Seek help for allergic reactions, a fast or pounding heartbeat, seizures, unusual movements or signs of liver problems.

Desloratadine warnings and precautions

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The biggest warning is serious allergic reaction, including rash, itching, hives, swelling, trouble breathing and anaphylaxis. Stop desloratadine at once if this happens and ask about other treatments.

  • About 6% of people in studies were slow metabolizers, with roughly 6-fold higher drug exposure. Safety looked similar in studies, but a higher risk cannot be ruled out.
  • Post-marketing reports include fast heartbeat, palpitations, seizures, movement disorders, hepatitis and raised liver enzymes.

Desloratadine interactions

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Some drugs raise desloratadine levels, but studies showed no clinically relevant change in safety.

  • Ketoconazole, erythromycin, azithromycin: increased desloratadine levels.
  • Fluoxetine: increased desloratadine levels.
  • Cimetidine: increased desloratadine levels.
  • Food and grapefruit juice: no effect on absorption.

Interactions listed in the FDA-approved label

From the Desloratadine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Inhibitors of Cytochrome P450 3A4 (ketoconazole, erythromycin, azithromycin): Co-administration resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but no clinically relevant changes in the safety profile of desloratadine.
  • Fluoxetine: Co-administration resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but no clinically relevant changes in the safety profile of desloratadine.
  • Cimetidine: Co-administration resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but no clinically relevant changes in the safety profile of desloratadine.
Read the label’s full interactions text

7 DRUG INTERACTIONS 7.1 Inhibitors of Cytochrome P450 3A4 In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3).] 7.2 Fluoxetine In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3).] 7.3 Cimetidine In controlled clinical studies co-administration of desloratadine with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3).]

7.1 Inhibitors of Cytochrome P450 3A4 In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3).]

7.2 Fluoxetine In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Desloratadine

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  • Do not use if you are allergic to desloratadine, its ingredients or loratadine.
  • Tell your prescriber about liver or kidney problems; dose changes are recommended for adults.
  • Pregnancy: data are too limited to inform risk.
  • Breastfeeding: desloratadine passes into breast milk; discuss with your doctor.
  • Older adults: dose selection should be cautious.
  • Children: the oral solution is not shown safe or effective under 6 months; dosing for children with liver or kidney disease cannot be recommended.

Desloratadine overdose

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In studies, sleepiness was reported at higher-than-recommended doses. Healthy volunteers given a much higher dose for 10 days had no clinically relevant adverse events. If an overdose happens, the label advises standard measures to remove unabsorbed drug and symptom-based supportive treatment. Hemodialysis does not remove desloratadine.

What Desloratadine does in the body

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Skin tests showed desloratadine's antihistamine effect begins by 1 hour and may last up to 24 hours. The effect did not wear off over 28 days. At a much higher dose than recommended, heart rate rose slightly, but no clinically relevant adverse events were reported.

How your body processes Desloratadine

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After a tablet, blood levels peak in about 3 hours. Food and grapefruit juice do not change absorption. The body converts desloratadine to an active metabolite, 3-hydroxydesloratadine, and clears it through urine and feces. The average half-life is about 27 hours, which supports once-daily dosing. Older adults had about 20% higher levels, which was not considered clinically important.

How to store Desloratadine

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Desloratadine Tablets: Store at 25° C (77° F); excursions permitted to 15° C - 30° C (59° F - 86° F) Heat sensitive. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

23

Supplements & herbs that interact with Desloratadine

23 supplements and herbal products have documented interactions with Desloratadine 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 · 1
  • Moderate · 13
  • Minor · 9
Every supplement checked against Desloratadine — ranked by severity The full interaction hub: 1 major · 13 moderate · 9 minor · every one linked to its full report. Check Desloratadine 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.

Desloratadine: pharmacist answers to common questions

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

What is desloratadine for?

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It relieves allergy symptoms from seasonal and year-round allergic rhinitis, like nasal and non-nasal symptoms. It also helps with chronic idiopathic urticaria, which means long-lasting hives with no known cause, by easing itching and reducing hives.

How do I take it?

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Take it by mouth once a day, with or without food. If you use the dissolving tablet, put it on your tongue and let it melt right after opening the blister. For liquid, use a dropper or syringe that is marked for the dose, and follow your prescriber's directions.

What side effects should I expect?

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Most people have few problems. Some get a sore throat, dry mouth, muscle aches, tiredness or sleepiness. People treated for hives also reported headache, nausea and dizziness.

When should I call my doctor?

▾
Stop the medicine and get help right away if you get a rash, hives, swelling or trouble breathing. Also call about a racing heartbeat, seizures, unusual movements or signs of liver problems.

Can I take it with other medicines?

▾
Ketoconazole, erythromycin, azithromycin, fluoxetine and cimetidine can raise desloratadine levels. In studies this did not cause clinically relevant safety changes. Tell me about all your medicines so I can check them.

Is it safe in pregnancy or breastfeeding?

▾
There is not enough information in people to know if it poses a risk in pregnancy. It does pass into breast milk. Talk with your doctor about the benefits and risks for you.

Is Desloratadine available over the counter?

▾
No. Desloratadine is a prescription medicine: every Desloratadine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Desloratadine first available?

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The earliest FDA record we hold for Desloratadine is from 2001: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Desloratadine was first used.

Who makes Desloratadine?

▾
10 companies currently list Desloratadine products in the FDA's NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack, Dr. Reddy's Laboratories Limited. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Desloratadine on HelloPharmacist

Detailed data & references for Desloratadine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Desloratadine forms and strengths (how it comes)

Desloratadine is available in 3 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Desloratadine inactive ingredients by manufacturer.

Tablet

By mouth
Brands Clarinex
How this form is used
What it may be used for
  • Clarinex tablets are used for seasonal allergic rhinitis in patients 2 years and older, per the Clarinex label.
  • Clarinex tablets are used for perennial allergic rhinitis and chronic idiopathic urticaria in patients 6 months and older, per the Clarinex label.
  • Desloratadine Tablets are used for seasonal and perennial allergic rhinitis and chronic idiopathic urticaria in patients 12 years and older.
Important instructions
  • Clarinex tablets may be taken without regard to meals.
  • Desloratadine Tablets are taken once daily, with or without food.
  • Desloratadine Tablets: adults with liver or kidney impairment may be started on a less frequent schedule, as directed by their prescriber.
Available strengths 1 strength
24 FDA-listed product records ⓘ

Orally disintegrating tablet

By mouth
How this form is used
What it may be used for
  • Desloratadine orally disintegrating tablets are used for seasonal allergic rhinitis in patients 2 years and older, per the label.
  • Desloratadine orally disintegrating tablets are used for perennial allergic rhinitis and chronic idiopathic urticaria in patients 6 months and older, per the label.
Important instructions
  • Desloratadine orally disintegrating tablets are placed on the tongue and left to dissolve before swallowing, with or without water.
  • Take Desloratadine orally disintegrating tablets right after opening the blister.
  • Desloratadine orally disintegrating tablets can be taken with or without food.
  • Desloratadine orally disintegrating tablets are not recommended for children under 6 years; the label says the syrup is better suited.
Available strengths 2 strengths
4 FDA-listed product records ⓘ

Oral solution

By mouth
How this form is used
What it may be used for
  • Desloratadine Oral Solution is used for seasonal allergic rhinitis in patients 2 years and older.
  • Desloratadine Oral Solution is used for perennial allergic rhinitis and chronic idiopathic urticaria in patients 6 months and older.
Important instructions
  • Desloratadine Oral Solution can be taken with or without food.
  • Desloratadine Oral Solution should be measured with a measuring dropper or syringe marked for the age-appropriate dose.
  • Desloratadine Oral Solution is taken once daily, with the amount based on age.
Available strengths 1 strength
1 FDA-listed product record ⓘ

Desloratadine on the U.S. market: products, makers and brands

How Desloratadine 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.

10 companies list 15 Desloratadine product records with the FDA, mostly as tablet, orally disintegrating tablet, oral solution; the earliest marketing or approval year on record is 2001. Brand names on the directory include Clarinex, Clarinex Reditabs; the rest are generics.

3
Dose forms ⓘ
10
Labelers (makers, repackagers, distributors)
3
Brand names
15
FDA-listed product records ⓘ
2001
Earliest FDA record ⓘ

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

A-S Medication Solutions20%
Bryant Ranch Prepack13%
Dr. Reddy's Laboratories Limited13%
Organon LLC13%
Bionpharma Inc.7%
INA Pharmaceutics, Inc.7%
Other makers27%

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

How widely Desloratadine is used (Medicaid data)

A general measure of how commonly Desloratadine 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 Desloratadine 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.

20,483
Medicaid prescriptions filled (Q1–Q4 2025)
$582,990 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Desloratadine prescribed? Of the 1,601 medications we measure, Desloratadine ranks #788 by Medicaid prescriptions — more than 51% of them.

Where Desloratadine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Desloratadine 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 5 mg oral tablet is the most-dispensed Desloratadine product — about 94% of these Medicaid prescriptions.

desloratadine 5 MG Oral Tablet Most dispensed

19,219 Medicaid prescriptions (Q1–Q4 2025) 94% of Desloratadine prescriptions shown $387,853 gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 6 of 44 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349420

desloratadine 5 MG Disintegrating Oral Tablet

712 Medicaid prescriptions (Q1–Q4 2025) 3% of Desloratadine prescriptions shown $125,913 gross reimbursement (before rebates) ≈ $177 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 403841

desloratadine 2.5 MG Disintegrating Oral Tablet

552 Medicaid prescriptions (Q1–Q4 2025) 3% of Desloratadine prescriptions shown $69,224 gross reimbursement (before rebates) ≈ $125 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 577080

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 Desloratadine, 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 8 of 48 listed Desloratadine NDCs with Medicaid activity.

Compare Desloratadine products

A representative set of FDA-listed product records for Desloratadine — 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.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Orally disintegrating tablet
2.5 mg Oral Dr. Reddy's Laboratories Limited ANDA View NDC →
5 mg Oral Dr. Reddy's Laboratories Limited ANDA View NDC →
💊Oral solution
0.5 mg/mL Oral INA Pharmaceutics, Inc. ANDA View NDC →
💊Tablet
5 mg Oral A-S Medication Solutions × 3 listings ANDA View NDC →
5 mg Oral Bionpharma Inc. ANDA View NDC →
5 mg Oral Bryant Ranch Prepack × 2 listings ANDA View NDC →
5 mg Oral Lupin Pharmaceuticals, Inc. ANDA View NDC →
5 mg Oral Morepen Bio Inc. ANDA View NDC →
5 mg Oral Natco Pharma USA LLC ANDA View NDC →
5 mg Oral Organon LLC × 2 listings NDA View NDC →
5 mg Oral Virtus Pharmaceuticals, LLC ANDA View NDC →

Showing 15 of 15 products — FDA National Drug Code Directory. See every product, package size and price: browse all 15 Desloratadine NDCs →

Desloratadine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Desloratadine recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Dec 20, 2023 · Terminated · Lupin Pharmaceuticals Inc.
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. Lots: Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count FDA record D-0221-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

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) Desloratadine RxCUI 275635 3 dose forms · 4 strengths
  1. Dose form (SCDF) Disintegrating Oral Tablet RxCUI 405907 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG RxCUI 577080 5 MG RxCUI 403841
  2. Dose form (SCDF) Oral Solution RxCUI 607572 In current FDA listings
    Clinical drug / strength (SCD) 0.5 MG/ML RxCUI 607573
  3. Dose form (SCDF) Oral Tablet RxCUI 378295 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 349420

Look up RxCUI 275635 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.

💵 What Desloratadine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Orally Disintegrating · Oral 5 mg $4.78 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Desloratadine brand names

Desloratadine is sold under 2 brand names in the FDA directory — Clarinex, Clarinex Reditabs. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Clarinex Clarinex Reditabs

Who makes Desloratadine: manufacturers and labelers

10 companies list Desloratadine products with the FDA. By number of product records, the largest are A-S Medication Solutions, Bryant Ranch Prepack, Dr. Reddy's Laboratories Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 3 Bryant Ranch Prepack 2 Dr. Reddy's Laboratories Limited 2 Organon LLC 2 Bionpharma Inc. 1 INA Pharmaceutics, Inc. 1 Lupin Pharmaceuticals, Inc. 1 Morepen Bio Inc. 1 Natco Pharma USA LLC 1 Virtus Pharmaceuticals, LLC 1

Desloratadine drug class (RxNorm)

Desloratadine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Other antihistamines for systemic use
How it works Histamine H1 Receptor Antagonists

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.

Sources for this Desloratadine page

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.

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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 May 17, 2025
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Desloratadine.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Desloratadine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
14
Finished products in the current FDA directory
15
Companies listing them (makers, repackagers, distributors)
10
FDA labeler codes behind them ⓘ
11
Linked representative label ⓘ
Organon LLC
Linked label effective
May 17, 2025
Composite sections available
24
Linked SPL Set ID
c671342e-69a2-4ca5-abc2-8166ed4240d4
Linked SPL Document ID
6ec783d3-9308-4f6b-bfda-b41888b95102
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Organon LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →