Over-the-counter medicine
Cetirizine and pseudoephedrine Brand names: Zyrtec-D; first approved as Zyrtec-D 12 Hour
Cetirizine and pseudoephedrine (Zyrtec-D) is an over-the-counter medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 24 generic labelers, and pharmacies paid $0.563 per cetirizine-pse ER 5-120 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the cetirizine and pseudoephedrine FDA label on DailyMed (effective April 6, 2026, Kenvue Brands LLC); the NDA 21150 record on Drugs@FDA; every cetirizine and pseudoephedrine label on DailyMed.
Highlights of the record
FDA label of April 6, 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 nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose
Forms and strengths
- 5 mg / 120 mg
Film-coated extended-release tablet; extended-release tablet.
On the market
- Earliest approval on file
- August 10, 2001 Zyrtec-D 12 Hour, Kenvue Brands; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first February 25, 2008; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 25 of which 24 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.563 per tablet Cetirizine-pse ER 5-120 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,073 through July 30, 2026
What is cetirizine 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 nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose
FDA pharmacologic class: Histamine-1 Receptor Antagonist and alpha-Adrenergic Agonist.
Source: FDA drug label (ZYRTEC-D), Kenvue Brands LLC, effective April 6, 2026 (SPL set f1ecf9ba-1c03-7fb7-e053-2a95a90a875a), via openFDA; the full label on DailyMed
Is there a generic for cetirizine and pseudoephedrine (Zyrtec-D)?
The FDA approved the first generic cetirizine and pseudoephedrine on February 25, 2008. 6 generic applications are approved; 4 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 cetirizine and pseudoephedrine from 24 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.
- 2001 earliest approval on file
- 2008 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cetirizine and pseudoephedrine (Zyrtec-D)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.563 per Cetirizine-pse ER 5-120 mg tablet, about the same as a year earlier. 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.
- Cetirizine-pse ER 5-120 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| All day allergy-d 5-120 mg tablet | Generic | $0.563 per tablet | $16.88 | n/a |
| All day allergy-d tablet | Generic | $0.563 per tablet | $16.88 | -0.1% |
| Allergy relief-d tablet | Generic | $0.563 per tablet | $16.88 | -0.1% |
| Allergy rlf-decong ER 5-120 mg | Generic | $0.563 per unit | n/a | n/a |
| Cetirizine-pse ER 5-120 mg tablet | Generic | $0.563 per tablet | $16.88 | -0.1% |
| Ft all day allergy-d 5-120 mg tablet | Generic | $0.563 per tablet | $16.88 | -0.1% |
| Ft all dy allergy-d 5-120 mg tablet | Generic | $0.563 per tablet | $16.88 | -0.1% |
| Gs all day allergy-d tablet | Generic | $0.563 per tablet | $16.88 | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the cetirizine and pseudoephedrine label say about other medicines?
The cetirizine and pseudoephedrine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Hydroxyzine | warnings | Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or … |
Check cetirizine and pseudoephedrine against other medicines
Source: FDA drug label (ZYRTEC-D), Kenvue Brands LLC, effective April 6, 2026 (SPL set f1ecf9ba-1c03-7fb7-e053-2a95a90a875a), via openFDA; the full label on DailyMed
What do FAERS reports show for cetirizine and pseudoephedrine?
The FDA Adverse Event Reporting System holds 3,073 reports that list cetirizine and pseudoephedrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 307 are coded as a death and 510 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?
- Other antihistamines
- the pharmacologic class, with prices and generics
- Cetirizine and pseudoephedrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other