Quick answers
- What is Zyrtec?
- Zyrtec is a brand name of Cetirizine and Cetirizine and pseudoephedrine, an over-the-counter medicine. The FDA NDC Directory lists 23 Zyrtec products in 10 strengths and forms.
- Who makes Zyrtec?
- Kenvue Brands holds the FDA application for Zyrtec (NDA019835, approved December 8, 1995). 7 other companies (repackagers or distributors) also list Zyrtec products.
- Is there a generic or store brand of Zyrtec?
- Yes. The FDA NDC Directory lists 198 other products with the same active ingredients, strength and form as a Zyrtec product, 174 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Zyrtec been recalled?
- No recall linked to Zyrtec products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Zyrtec is
Each Zyrtec product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Cetirizine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| cetirizine hydrochloride 1 mg/mL solution (oral) | Zyrtec Hives | 26 products, 18 companies | DailyMed |
| cetirizine hydrochloride 10 mg capsule (oral) | Zyrtec Allergy Cetirizine HCl | 40 products, 28 companies | DailyMed |
| cetirizine hydrochloride 10 mg capsule, liquid filled (oral) | ZYRTEC Allergy | 15 products, 12 companies | DailyMed |
| cetirizine hydrochloride 10 mg tablet, chewable (oral) | Childrens Zyrtec, Zyrtec | 2 products, 2 companies | DailyMed |
| cetirizine hydrochloride 10 mg tablet, film coated (oral) | Zyrtec Allergy, ZYRTEC Hives | 75 products, 55 companies | DailyMed |
| cetirizine hydrochloride 10 mg tablet, orally disintegrating (oral) | Zyrtec Allergy, Childrens Zyrtec Allergy | 11 products, 6 companies | DailyMed |
| cetirizine hydrochloride 2.5 mg tablet, chewable (oral) | Childrens Zyrtec | None listed | DailyMed |
| cetirizine hydrochloride 5 mg tablet, film coated (oral) | Zyrtec Allergy | 1 product, 1 company | DailyMed |
| cetirizine hydrochloride 5 mg/5 mL syrup (oral) | Childrens Zyrtec Allergy, Childrens Zyrtec | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Cetirizine →
Cetirizine and pseudoephedrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| cetirizine hydrochloride 5 mg · pseudoephedrine hydrochloride 120 mg tablet, film coated, extended release (oral) | ZYRTEC-D Allergy Plus Congestion, Zyrtec-D | 28 products, 24 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Cetirizine and pseudoephedrine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA019835 | Kenvue Brands | December 8, 1995 | 8 |
| NDA021150 | Kenvue Brands | August 10, 2001 | 2 |
| NDA021621 | Kenvue Brands | March 16, 2004 | 5 |
| NDA022155 | Kenvue Brands | November 16, 2007 | 3 |
| NDA022578 | Kenvue Brands | September 3, 2010 | 2 |
| ANDA213105 | Catalent | September 21, 2020 | 3 |
Companies that list Zyrtec
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Zyrtec products.
- Kenvue Brands LLC14 products
- Jones Healthcare Group - Packaging Services, Inc2 products
- A-S Medication Solutions2 products
- Select Consumer Group1 product
- Savings Distributors LLC1 product
- Morning Star OTC1 product
- Navajo Manufacturing Company Incorporated1 product
- RedPharm Drug Inc1 product
Recalls
No recall linked to Zyrtec products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.