Zyrtec Allergy
- Product NDC
- 50580-754
- 11-digit product format
- 505800754
- Labeler code
- 50580
- Product ID
- 50580-754_3a6e2ec1-eab8-beec-e063-6394a90aa39c
- 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
- 2025-02-15
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 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 Allergy
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014676, 1014677 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-754-15 | Zyrtec Allergy | 15 in 1 CARTON | TABLET, FILM COATED | 15 | | 3 |
| 50580-754-15 | Zyrtec Allergy | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 3 |
| 50580-754-35 | Zyrtec Allergy | 35 in 1 BOTTLE | TABLET, FILM COATED | 35 | | 3 |
| 50580-754-35 | Zyrtec Allergy | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-754 | ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] | 1 | Current NDC, 4 package rows | 20250216_2c1ecee3-c2c1-25a2-e063-6294a90aad54.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 |
|---|
| 50580-754-15 | 50580075415 | 15 POUCH in 1 CARTON (50580-754-15) / 1 TABLET, FILM COATED in 1 POUCH | 15 pouch | 2025-02-15 | No | No | Current |
| 50580-754-35 | 50580075435 | 1 BOTTLE in 1 CARTON (50580-754-35) / 35 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2025-02-15 | No | No | Current |