ZYRTEC Hives
- Product NDC
- 50580-116
- 11-digit product format
- 505800116
- Labeler code
- 50580
- Product ID
- 50580-116_37b38291-50c9-00c9-e063-6394a90a83ef
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- NDA019835
- Marketing category
- NDA
- Marketing start
- 2025-06-02
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZYRTEC Hives
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014678, 1020026 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-116-30 | ZYRTEC Hives | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 50580-116-30 | ZYRTEC Hives | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50580-116-30 | 50580011630 | 1 BOTTLE in 1 CARTON (50580-116-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2025-06-02 | No | No | Current |