Over-the-counter medicine
Loratadine and pseudoephedrine Brand names: Claritin-D
Loratadine and pseudoephedrine (Claritin-D) is an over-the-counter medicine with an FDA approval on record since 1994. FDA's NDC Directory lists it from 29 generic labelers, and pharmacies paid $0.553 per allergy relief-nasal decong tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the loratadine and pseudoephedrine FDA label on DailyMed (effective September 1, 2026, L. Perrigo Company); the NDA 19670 record on Drugs@FDA; every loratadine and pseudoephedrine label on DailyMed.
Highlights of the record
FDA label of September 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
sneezing
itchy, watery eyes
runny nose
itching of the nose or throat
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through th
Forms and strengths
- 5 mg / 120 mg
- 10 mg / 240 mg
- 240 mg / 10 mg
Film-coated extended-release tablet; extended-release tablet.
On the market
- Earliest approval on file
- November 14, 1994 Claritin-D, Bayer Healthcare Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first January 30, 2003; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 29 of which 29 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.553 per tablet Allergy relief-nasal decong tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2014 0 Class I among all firms' recalls; latest October 12, 2021
- FAERS reports
- 8,238 through July 30, 2026
What is loratadine and pseudoephedrine used for?
From the label: indications and usagetemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
sneezing
itchy, watery eyes
runny nose
itching of the nose or throat
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose
Conditions named in the indications of loratadine and pseudoephedrine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: alpha-Adrenergic Agonist.
Source: FDA drug label (perrigo allergy d), L. Perrigo Company, effective September 1, 2026 (SPL set 955c9f49-38af-4b48-b325-60fa94bfe60b), via openFDA; the full label on DailyMed
Is there a generic for loratadine and pseudoephedrine (Claritin-D)?
The FDA approved the first generic loratadine and pseudoephedrine on January 30, 2003. 7 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists loratadine and pseudoephedrine from 29 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1994 earliest approval on file
- 2003 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for loratadine and pseudoephedrine (Claritin-D)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.553 per Allergy relief-nasal decong tablet, up 4% from $0.531 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Allergy relief-nasal decong tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Allergy d-12hr 5-120 mg tablet | Generic | $0.782 per tablet | $23.45 | n/a |
| Allergy d-24hr 10-240 mg tablet | Generic | $0.553 per tablet | $16.60 | n/a |
| Allergy relief d-12 tablet | Generic | $0.782 per tablet | $23.45 | -1% |
| Allergy relief d-24hr tablet | Generic | $0.553 per tablet | $16.60 | +4% |
| Allergy relief-nasal decong tablet | Generic | $0.553 per tablet | $16.60 | +4% |
| Allergy-conges relf ER tablet | Generic | $0.553 per tablet | $16.60 | +4% |
| Allergy-congestion rlf 12h tablet | Generic | $0.782 per tablet | $23.45 | -1% |
| Ft allergy d-12hr 5-120 mg tablet | Generic | $0.782 per tablet | $23.45 | -1% |
| Ft allergy relief d-24hr tablet | Generic | $0.553 per tablet | $16.60 | +4% |
| Gnp loratadine-d 12 hr tablet | Generic | $0.782 per tablet | $23.45 | -1% |
| Loratadine-d 12 hour tablet | Generic | $0.782 per tablet | $23.45 | -1% |
| Loratadine-d 24hr tablet | Generic | $0.553 per tablet | $16.60 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has loratadine and pseudoephedrine been recalled?
The FDA's Enforcement Report lists 3 recalls naming loratadine and pseudoephedrine since 2014: 0 Class I (the most serious), 1 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 12, 2021 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Moisture Limits |
| February 7, 2014 | Class II | Ohm Laboratories, Inc. | Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for loratadine and pseudoephedrine?
The FDA Adverse Event Reporting System holds 8,238 reports that list loratadine and pseudoephedrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 101 are coded as a death and 646 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as loratadine and pseudoephedrine?
13 other medicines are given the same way (oral) and in the same FDA class as loratadine and pseudoephedrine or labeled mainly for the same use (cough and cold), the same class first. Cough and cold lists all 31 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Diphenhydramine | Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Dextromethorphan and guaifenesin | Cough and cold | 61 labelers | $0.0207 per mL 200-20 mg/20 mL | No current entry |
| Guaifenesin | Cough and cold | 102 labelers | $0.284 per tablet 600 mg tablet | No current entry |
| Benzonatate | Cough and cold | 45 labelers | $0.0656 per capsule 100 mg capsule | No current entry |
| Dextromethorphan | Cough and cold | 28 labelers | $0.122 per unit 15 mg softgel | No current entry |
| Phenylephrine | Cough and cold | none listed | $0.0496 per tablet 10 mg tablet | No current entry |
| Dextromethorphan and promethazine | Cough and cold | 13 labelers | $0.039 per mL 6.25-15 mg/5 mL solution | No current entry |
| Homatropine methylbromide and hydrocodone | Cough and cold | 3 labelers | $0.922 per tablet 5-1.5 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other alpha-adrenergic agonists
- the pharmacologic class, with prices and generics
- Loratadine and pseudoephedrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other