Over-the-counter medicine
Fexofenadine Brand names: Allegra
Fexofenadine (Allegra) is an over-the-counter medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 101 generic labelers, and pharmacies paid $0.230 per fexofenadine HCl 180 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the fexofenadine FDA label on DailyMed (effective June 15, 2026, Granules India Ltd); the NDA 20625 record on Drugs@FDA; every fexofenadine label on DailyMed.
Highlights of the record
FDA label of June 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usage(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, water eyes sneezing itching of the nose or throat
Forms and strengths
- 30 mg
- 60 mg
- 180 mg
- 30 mg/5ml
Tablet; film-coated tablet; suspension; coated tablet; coated capsule.
On the market
- Earliest approval on file
- July 25, 1996 Allegra, Chattem Sanofi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first July 13, 2005; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 104 of which 101 under generic applications, 4 under brand applications, repackagers included; 1 more under the over-the-counter monograph, without an application
- Last listed patent
- August 2, 2030 Children'S Allegra Allergy oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.230 per tablet Fexofenadine HCl 180 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 21 since 2013 0 Class I among all firms' recalls; latest June 1, 2026; 4 more by firms not listed as its makers
- FAERS reports
- 40,772 through July 30, 2026
What is fexofenadine used for?
From the label: indications and usage(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, water eyes sneezing itching of the nose or throat
Conditions named in the indications of fexofenadine's FDA labels, with every medicine labeled for each:
From other fexofenadine labelsAllergies: Use(s) Allergy temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat Hives reduces hives and relieves itching due to hives (urticaria).
FDA pharmacologic class: Histamine-1 Receptor Antagonist.
Source: FDA drug label (Fexofenadine Hydrochloride), Granules India Ltd, effective June 15, 2026 (SPL set 3151bc6d-b40b-4200-a5cf-e57b6791d92a), via openFDA; the full label on DailyMed
Is there a generic for fexofenadine (Allegra)?
The FDA approved the first generic fexofenadine on July 13, 2005. 20 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists fexofenadine from 101 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Allegra oral suspension; a patent listed only for Children'S Allegra Allergy oral suspension runs to August 2, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2005 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fexofenadine (Allegra)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.230 per Fexofenadine HCl 180 mg tablet, down 13% from $0.265 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.
- Fexofenadine HCl 180 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Allergy relief 180 mg tablet | Generic | $0.230 per tablet | $6.91 | -13% |
| Allergy rlf (fexo) 60 mg tablet | Generic | $0.153 per tablet | $4.59 | -9% |
| Child allergy (fexo) 30 mg/5 mL | Generic | $0.119 per mL | n/a | +95% |
| Fexofenadine HCl 180 mg tablet | Generic | $0.230 per tablet | $6.91 | -13% |
| Fexofenadine HCl 60 mg tablet | Generic | $0.153 per tablet | $4.59 | -9% |
| Ft allergy (fexo) 180 mg tablet | Generic | $0.230 per tablet | $6.91 | -13% |
| Gnp fexofenadine HCl 180 mg tablet | Generic | $0.230 per tablet | $6.91 | -13% |
| Gs aller-ease 180 mg tablet | Generic | $0.230 per tablet | $6.91 | -13% |
| Qc allergy (fexo) 180 mg tablet | Generic | $0.230 per tablet | $6.91 | -13% |
| Qc allergy rlf (fexo) 60 mg tablet | Generic | $0.153 per tablet | $4.59 | -9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fexofenadine been recalled?
The FDA's Enforcement Report lists 25 recalls naming fexofenadine since 2013: 0 Class I (the most serious), 22 Class II, 3 Class III; 1 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of fexofenadine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 1, 2026 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Impurities/Degradation Specifications |
| January 18, 2024 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. |
| February 9, 2023 | Class II | L. Perrigo Company | Failed Impurities/Degradation Specifications |
| August 3, 2021 | Class II | The Harvard Drug Group | Failed Impurities/Degradation Specifications |
| July 27, 2021 | Class II | Perrigo Company PLC | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| August 29, 2019 | Class II | Preferred Pharmaceuticals, Inc | Failed Impurities/Degradation Specifications |
| August 23, 2019 | Class II | Aurolife Pharma, LLC | Failed Impurities/Degradation Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fexofenadine label say about other medicines?
The fexofenadine label names no other medicine on this site. The labels of 3 other medicines name fexofenadine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Fexofenadine Hydrochloride), Granules India Ltd, effective June 15, 2026 (SPL set 3151bc6d-b40b-4200-a5cf-e57b6791d92a), via openFDA; the full label on DailyMed
What do FAERS reports show for fexofenadine?
The FDA Adverse Event Reporting System holds 40,772 reports that list fexofenadine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,660 are coded as a death and 7,642 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 fexofenadine?
11 other medicines are given the same way (oral) and in the same FDA class as fexofenadine or labeled mainly for the same use (allergies), the same class first. Allergies lists all 36 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 | Allergies | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Cetirizine | Allergies | 164 labelers | $0.0613 per tablet 10 mg tablet | No current entry |
| Levocetirizine | Allergies | 53 labelers | $0.0511 per tablet 5 mg tablet | No current entry |
| Chlorpheniramine | Allergies | 2 labelers | $0.0177 per tablet 4 mg tablet | No current entry |
| Desloratadine | Allergies | 9 labelers | $0.258 per tablet 5 mg tablet | No current entry |
| Carbinoxamine | Allergies | 7 labelers | $0.398 per tablet 4 mg tablet | No current entry |
| Chlorpheniramine and ibuprofen and phenylephrine | Allergies | none listed | n/a | No current entry |
| Chlorpheniramine and ibuprofen and pseudoephedrine | Allergies | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as fexofenadine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fexofenadine compare with medicines for the same use?
6 side-by-side pages set fexofenadine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fexofenadine
- 11 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Fexofenadine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other