Childrens Zyrtec Allergy
- Product NDC
- 50580-782
- 11-digit product format
- 505800782
- Labeler code
- 50580
- Product ID
- 50580-782_327f7ae1-8b12-ef7a-e063-6294a90abd4a
- 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
- Childrens 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 |
|---|
| 50580-782-01 | Childrens Zyrtec Allergy | 4 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 4 | | 11 |
| 50580-782-01 | Childrens Zyrtec Allergy | 2 in 1 PACKAGE | TABLET, ORALLY DISINTEGRATING | 2 | | 11 |
| 50580-782-12 | Childrens Zyrtec Allergy | 2 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 2 | | 11 |
| 50580-782-12 | Childrens Zyrtec Allergy | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | | 11 |
| 50580-782-24 | Childrens Zyrtec Allergy | 4 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 4 | | 11 |
| 50580-782-24 | Childrens Zyrtec Allergy | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Cetirizine Hydrochloride | ACTIVE INGREDIENT | 64O047KTOA | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| Cetirizine | ACTIVE MOIETY | YO7261ME24 | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer | INACTIVE INGREDIENT | 905HNO1SIH | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| hydroxypropyl cellulose (type e) | INACTIVE INGREDIENT | 66O7AQV0RT | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| sodium bicarbonate | INACTIVE INGREDIENT | 8MDF5V39QO | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| sodium starch glycolate Type A Potato | INACTIVE INGREDIENT | 5856J3G2A2 | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-782 | CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [KENVUE BRANDS LLC] | 11 | Current NDC, Legacy NDC, 6 package rows | 20250426_a1edc2e6-3661-4d7a-884c-709d73cb89e0.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 |
|---|
| 50580-782-01 | 50580078201 | 2 CARTON in 1 PACKAGE (50580-782-01) / 4 BLISTER PACK in 1 CARTON / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2 carton | 2014-01-20 | 0000-00-00 | No | No | Current |
| 50580-782-12 | 50580078212 | 2 BLISTER PACK in 1 CARTON (50580-782-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2 blister pack | 2014-01-20 | 0000-00-00 | No | No | Current |
| 50580-782-24 | 50580078224 | 4 BLISTER PACK in 1 CARTON (50580-782-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 4 blister pack | 2014-01-20 | 0000-00-00 | No | No | Current |