Zyrtec Allergy
- Product NDC
- 50580-778
- 11-digit product format
- 505800778
- Labeler code
- 50580
- Product ID
- 50580-778_3254957b-3bb2-98a9-e063-6394a90a9358
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- NDA022578
- Marketing category
- NDA
- Marketing start
- 2014-01-20
- 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 Allergy
- 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 | 1011482, 1011485 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-778-12 | Zyrtec Allergy | 2 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 2 | | 17 |
| 50580-778-12 | Zyrtec Allergy | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | | 17 |
| 50580-778-24 | Zyrtec Allergy | 4 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 4 | | 17 |
| 50580-778-24 | Zyrtec Allergy | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | | 17 |
| 50580-778-66 | Zyrtec Allergy | 11 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 11 | | 17 |
| 50580-778-66 | Zyrtec Allergy | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Cetirizine Hydrochloride | ACTIVE INGREDIENT | 64O047KTOA | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| Cetirizine | ACTIVE MOIETY | YO7261ME24 | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer | INACTIVE INGREDIENT | 905HNO1SIH | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| hydroxypropyl cellulose (type E) | INACTIVE INGREDIENT | 66O7AQV0RT | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| sodium bicarbonate | INACTIVE INGREDIENT | 8MDF5V39QO | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| sodium starch glycolate type a potato | INACTIVE INGREDIENT | 5856J3G2A2 | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
| sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-778 | ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [KENVUE BRANDS LLC] | 17 | Current NDC, Legacy NDC, 6 package rows | 20250413_6a962a1c-c197-492b-bfa6-e0c28eda1533.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50580-778-12 | 50580077812 | 2 in 1 CARTON | | | | | | Historical |
| 50580-778-24 | 50580077824 | 4 BLISTER PACK in 1 CARTON (50580-778-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 4 blister pack | 2014-01-20 | 0000-00-00 | No | No | Current |
| 50580-778-66 | 50580077866 | 11 in 1 CARTON | | | | | | Historical |