Quick answers
- What is Claritin?
- Claritin is a brand name of Loratadine and Loratadine and pseudoephedrine, an over-the-counter medicine. The FDA NDC Directory lists 24 Claritin products in 9 strengths and forms.
- Who makes Claritin?
- Bayer Healthcare LLC holds the FDA application for Claritin (NDA019658, approved April 12, 1993). 4 other companies (repackagers or distributors) also list Claritin products.
- Is there a generic or store brand of Claritin?
- Yes. The FDA NDC Directory lists 333 other products with the same active ingredients, strength and form as a Claritin product, 329 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Claritin been recalled?
- No recall linked to Claritin products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Claritin is
Each Claritin 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.
Loratadine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| loratadine 1 mg/mL solution (oral) | Claritin Allergy | None listed | DailyMed |
| loratadine 10 mg tablet (oral) | Claritin | 175 products, 103 companies | DailyMed |
| loratadine 10 mg tablet, chewable (oral) | Claritin Chewable Cool Mint Flavor | 1 product, 1 company | DailyMed |
| loratadine 10 mg tablet, orally disintegrating (oral) | Claritin Reditabs | 41 products, 30 companies | DailyMed |
| loratadine 5 mg tablet, chewable (oral) | Claritin | 48 products, 25 companies | DailyMed |
| loratadine 5 mg tablet, orally disintegrating (oral) | Claritin Reditabs | 2 products, 2 companies | DailyMed |
| loratadine 5 mg/5 mL solution (oral) | Children Claritin Allergy | 51 products, 34 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Loratadine →
Loratadine and pseudoephedrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| loratadine 10 mg · pseudoephedrine sulfate 240 mg tablet, extended release (oral) | Claritin-D 24 Hour | 15 products, 14 companies | DailyMed |
| loratadine 5 mg · pseudoephedrine sulfate 120 mg tablet, extended release (oral) | Claritin-D 12 Hour | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Loratadine 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 |
|---|---|---|---|
| NDA019658 | Bayer Healthcare LLC | April 12, 1993 | 7 |
| NDA019670 | Bayer Healthcare LLC | November 14, 1994 | 1 |
| NDA020470 | Bayer Healthcare LLC | August 23, 1996 | 1 |
| NDA020641 | Bayer Healthcare LLC | October 10, 1996 | 2 |
| NDA020704 | Bayer Healthcare LLC | December 23, 1996 | 2 |
| ANDA075209 | PLD Acquisitions LLC | January 21, 2003 | 4 |
| ANDA075706 | P and L | February 21, 2003 | 1 |
| NDA021891 | Bayer Healthcare LLC | August 23, 2006 | 4 |
| NDA021993 | Bayer Healthcare LLC | December 12, 2006 | 1 |
| ANDA210033 | Perrigo Pharma Intl | June 12, 2019 | 1 |
Companies that list Claritin
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Claritin products.
- Bayer HealthCare LLC.20 products
- Select Consumer Group1 product
- Lil' Drug Store Products, Inc.1 product
- Navajo Manufacturing Company Inc.1 product
- R J General Corporation1 product
Recalls
No recall linked to Claritin 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.