ZYRTEC HIVES
- Product NDC
- 50580-128
- 11-digit product format
- 505800128
- Labeler code
- 50580
- Product ID
- 50580-128_37b3c47a-f31a-20f4-e063-6294a90ab07a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- NDA022155
- Marketing category
- NDA
- Marketing start
- 2025-04-02
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- 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 | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014673, 1020021 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-128-04 | ZYRTEC HIVES | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 50580-128-04 | ZYRTEC HIVES | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-128 | ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] | 1 | Current NDC, 2 package rows | 20250406_31400cb2-fe85-ef74-e063-6294a90a11fb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50580-128-04 | 50580012804 | 1 BOTTLE in 1 CARTON (50580-128-04) / 118 mL in 1 BOTTLE | 1 bottle | 2025-04-02 | No | No | Current |