Prescription and over-the-counter medicine
Loratadine Brand names: Claritin, Alavert, Lil
Loratadine (Lil) is a prescription and over-the-counter medicine with an FDA approval on record since 1993. FDA's NDC Directory lists it from 149 generic labelers, and pharmacies paid $0.0529 per loratadine 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the loratadine FDA label on DailyMed (effective December 5, 2025, Bayer HealthCare LLC.); the NDA 19658 record on Drugs@FDA; every loratadine label on DailyMed.
Highlights of the record
FDA label of December 5, 2025; 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: runny nose itchy, watery eyes sneezing itching of the nose or throat
Forms and strengths
- 5 mg
- 10 mg
- 1 mg/ml
- 5 mg/5ml
Tablet; chewable tablet; solution; orally disintegrating tablet; liquid-filled capsule.
On the market
- Earliest approval on file
- April 12, 1993 Claritin, Bayer Healthcare Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 38 first January 21, 2003; 30 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 154 of which 149 under generic applications, 7 under brand applications, repackagers included; 1 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.0529 per tablet Loratadine 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 106,995 through July 30, 2026
What is loratadine used for?
From the label: indications and usagetemporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
Source: FDA drug label (Claritin), Bayer HealthCare LLC., effective December 5, 2025 (SPL set 660ac9df-f1b1-4c89-94dd-9fae0a013f3c), via openFDA; the full label on DailyMed
Is there a generic for loratadine (Lil)?
The FDA approved the first generic loratadine on January 21, 2003. 38 generic applications are approved; 30 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 from 149 labelers under a generic (ANDA) application and from 7 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1993 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 (Lil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0529 per Loratadine 10 mg tablet, down 7% from $0.0567 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.
- Loratadine 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Allergy (loratadine) 10 mg tablet | Generic | $0.0529 per tablet | $1.59 | -7% |
| Allergy relief 10 mg tablet | Generic | $0.0529 per tablet | $1.59 | -7% |
| Allergy relief 5 mg/5 mL solution | Generic | $0.0414 per mL | n/a | -1% |
| Child allergy 5 mg/5 mL solution | Generic | $0.0436 per mL | n/a | -0.3% |
| Child allergy relief 5 mg/5 mL | Generic | $0.0414 per mL | n/a | -1% |
| Child loratadine 5 mg tablet chewable | Generic | $0.521 per tablet | $15.64 | +10% |
| Child loratadine 5 mg/5 mL solution | Generic | $0.0414 per mL | n/a | -1% |
| Ft allergy (lorat) 10 mg tablet | Generic | $0.0529 per tablet | $1.59 | -7% |
| Ft child allergy 5 mg/5 mL solution | Generic | $0.0414 per mL | n/a | -1% |
| Ft child allergy rlf 5 mg chewable | Generic | $0.521 per unit | n/a | +10% |
| Gnp child loratadine 5 mg/5 mL | Generic | $0.0414 per mL | n/a | -1% |
| Gnp loratadine 10 mg ODT | Generic | $0.527 per unit | n/a | -27% |
| Gnp loratadine 10 mg tablet | Generic | $0.0529 per tablet | $1.59 | -8% |
| Gs allergy (lorat) 10 mg tablet | Generic | $0.0529 per tablet | $1.59 | -7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has loratadine been recalled?
The FDA's Enforcement Report lists 5 recalls naming loratadine since 2013: 0 Class I (the most serious), 3 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| July 28, 2015 | Class III | Ohm Laboratories, Inc. | Superpotent Drug: Out Of Specification (OOS) result for Assay. |
| September 3, 2013 | Class III | Novartis Consumer Health | Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; LORATADINE Tablet, 10 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W002650, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the loratadine label say about other medicines?
The loratadine label names no other medicine on this site. The labels of 3 other medicines name loratadine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name loratadine
Source: FDA drug label (Claritin), Bayer HealthCare LLC., effective December 5, 2025 (SPL set 660ac9df-f1b1-4c89-94dd-9fae0a013f3c), via openFDA; the full label on DailyMed
What do FAERS reports show for loratadine?
The FDA Adverse Event Reporting System holds 106,995 reports that list loratadine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,661 are coded as a death and 23,139 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 next?
- Alternatives to loratadine
- medicines labeled for the same conditions
- Loratadine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other