Home NDC 50580-721 Childrens Zyrtec Allergy
Product NDC 50580-721
11-digit product format 505800721
Labeler code 50580
Product ID 50580-721_48bb7dd3-c2b8-ecfb-e063-6294a90af77d
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Kenvue Brands LLC
Application NDA022155
Marketing category NDA
Marketing start 2009-01-20
Substance CETIRIZINE HYDROCHLORIDE
Active strength 5 mg/5mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022155-001 CHILDREN'S ZYRTEC HIVES CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 N022155-002 CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Additional Listing Data#
Finished product Yes
Brand name base Childrens Zyrtec Allergy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 5 mg/5mL
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 50580-721-05 Childrens Zyrtec Allergy 118 mL in 1 BOTTLE, PLASTIC SYRUP 118 10 50580-721-05 Childrens Zyrtec Allergy 1 in 1 CARTON SYRUP 1 10
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) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 Cetirizine ACTIVE MOIETY YO7261ME24 CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 sorbitol INACTIVE INGREDIENT 506T60A25R CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 water INACTIVE INGREDIENT 059QF0KO0R CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-721 CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [KENVUE BRANDS LLC] 8 Current NDC, Legacy NDC, 2 package rows 20250515_ee8695ac-1293-4e43-ac7c-a64e21a0ca0a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50580-721-05 50580072105 1 BOTTLE, PLASTIC in 1 CARTON (50580-721-05) / 118 mL in 1 BOTTLE, PLASTIC 2015-07-13 0000-00-00 No No Current