Home NDC 50580-730 Childrens Zyrtec
Product NDC 50580-730
11-digit product format 505800730
Labeler code 50580
Product ID 50580-730_40cb0507-49ef-8320-e063-6294a90ae39f
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Kenvue Brands LLC
Application NDA022155
Marketing category NDA
Marketing start 2009-06-01
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 2026-12-31
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 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 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
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Cetirizine Hydrochloride ACTIVE INGREDIENT 64O047KTOA CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 Cetirizine ACTIVE MOIETY YO7261ME24 CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 sorbitol INACTIVE INGREDIENT 506T60A25R CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 3 water INACTIVE INGREDIENT 059QF0KO0R CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [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 50580-730 CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [KENVUE BRANDS LLC] 16 Current NDC, Legacy NDC, 12 package rows 20250522_9d8e78ea-af98-4f7c-8db5-044b49582f80.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 50580-730-01 50580073001 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-01) / 30 mL in 1 BOTTLE, PLASTIC 2017-01-16 0000-00-00 No No Current 50580-730-05 50580073005 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-05) / 118 mL in 1 BOTTLE, PLASTIC 2015-07-13 0000-00-00 No No Current 50580-730-06 50580073006 2 CARTON in 1 PACKAGE (50580-730-06) / 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC 2 carton 2015-07-31 0000-00-00 No No Current 50580-730-17 50580073017 3 TRAY in 1 PACKAGE (50580-730-17) / 1 BOTTLE in 1 TRAY / 118 mL in 1 BOTTLE 3 tray 2018-12-03 0000-00-00 No No Current 50580-730-18 50580073018 2 CARTON in 1 PACKAGE (50580-730-18) / 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2 carton 2018-12-03 0000-00-00 No No Current 50580-730-19 50580073019 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-19) / 240 mL in 1 BOTTLE, PLASTIC 2020-06-16 0000-00-00 No No Current