Over-the-counter medicine
Fexofenadine and pseudoephedrine Brand names: Allegra-D; first approved as Allegra-D 12 Hour Allergy And Congestion
Fexofenadine and pseudoephedrine (Allegra-D) is an over-the-counter medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 26 generic labelers, and pharmacies paid $0.483 per fexofenadine-pse ER 60-120 tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the fexofenadine and pseudoephedrine FDA label on DailyMed (effective January 12, 2026, Chattem, Inc.); the NDA 20786 record on Drugs@FDA; every fexofenadine and pseudoephedrine label on DailyMed.
Highlights of the record
FDA label of January 12, 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:
runny nose
sneezing
itchy, watery eyes
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
Forms and strengths
- 60 mg / 120 mg
- 180 mg / 240 mg
Film-coated extended-release tablet; extended-release tablet.
On the market
- Earliest approval on file
- December 24, 1997 Allegra-D 12 Hour Allergy And Congestion, Chattem Sanofi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first April 14, 2005; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 26 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.483 per tablet Fexofenadine-pse ER 60-120 tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2021 0 Class I among all firms' recalls; latest January 4, 2022
- FAERS reports
- 49 through July 30, 2026
What is fexofenadine and pseudoephedrine used for?
From the label: indications and usagetemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy, watery eyes
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 fexofenadine and pseudoephedrine's FDA labels, with every medicine labeled for each:
From other fexofenadine and pseudoephedrine labelsCough and cold: … sneezing ▪ itchy, watery eyes ▪ 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 …
FDA pharmacologic class: Histamine-1 Receptor Antagonist and alpha-Adrenergic Agonist.
Source: FDA drug label (Allegra-D Allergy and Congestion), Chattem, Inc., effective January 12, 2026 (SPL set 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403), via openFDA; the full label on DailyMed
Is there a generic for fexofenadine and pseudoephedrine (Allegra-D)?
The FDA approved the first generic fexofenadine and pseudoephedrine on April 14, 2005. 9 generic applications are approved; 7 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 3 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 and pseudoephedrine from 26 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1997 earliest approval on file
- 2005 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 fexofenadine and pseudoephedrine (Allegra-D)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.483 per Fexofenadine-pse ER 60-120 tablet, up 17% from $0.412 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-pse ER 60-120 tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fexofenadine-pse ER 60-120 tablet | Generic | $0.483 per tablet | $14.50 | +17% |
| Gnp fexofenadine-pse ER 60-120 | Generic | $0.483 per unit | n/a | +17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fexofenadine and pseudoephedrine been recalled?
The FDA's Enforcement Report lists 5 recalls naming fexofenadine and pseudoephedrine since 2021: 0 Class I (the most serious), 0 Class II, 5 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 4, 2022 | Class III | Dr. Reddy's Laboratories, Inc. | Failed Dissolution Specifications |
| November 12, 2021 | Class III | Dr. Reddy's Laboratories, Inc. | Failed dissolution specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for fexofenadine and pseudoephedrine?
The FDA Adverse Event Reporting System holds 49 reports that list fexofenadine and pseudoephedrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 7 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.
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 and pseudoephedrine?
14 other medicines are given the same way (oral) and in the same FDA class as fexofenadine 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 |
| Chlorpheniramine and ibuprofen and phenylephrine | Cough and cold | none listed | n/a | No current entry |
| Chlorpheniramine and hydrocodone | Cough and cold | 2 labelers | $0.556 per mL Hydrocodone-chlorphen ER suspension | No current entry |
| Chlorpheniramine and codeine | Cough and cold | none listed | n/a | 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 |
Every medicine labeled for the same conditions as fexofenadine and pseudoephedrine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to fexofenadine and pseudoephedrine
- 14 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Fexofenadine and pseudoephedrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other