childrens zyrtec

Generic: cetirizine hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens zyrtec
Generic Name cetirizine hydrochloride
Labeler kenvue brands llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/5mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-730
Product ID 50580-730_40cb0507-49ef-8320-e063-6294a90ae39f
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022155
Listing Expiration 2026-12-31
Marketing Start 2009-06-01

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580730
Hyphenated Format 50580-730

Supplemental Identifiers

RxCUI
1014673 1020021
UPC
0300450209269
UNII
64O047KTOA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name childrens zyrtec (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number NDA022155 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-01) / 30 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-05) / 118 mL in 1 BOTTLE, PLASTIC
  • 2 CARTON in 1 PACKAGE (50580-730-06) / 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
  • 3 TRAY in 1 PACKAGE (50580-730-17) / 1 BOTTLE in 1 TRAY / 118 mL in 1 BOTTLE
  • 2 CARTON in 1 PACKAGE (50580-730-18) / 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-19) / 240 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (6)

50580-730-01 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-01) / 30 mL in 1 BOTTLE, PLASTIC 50580-730-05 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-05) / 118 mL in 1 BOTTLE, PLASTIC 50580-730-06 2 CARTON in 1 PACKAGE (50580-730-06) / 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC 50580-730-17 3 TRAY in 1 PACKAGE (50580-730-17) / 1 BOTTLE in 1 TRAY / 118 mL in 1 BOTTLE 50580-730-18 2 CARTON in 1 PACKAGE (50580-730-18) / 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 50580-730-19 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-19) / 240 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Childrens Zyrtec ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40cb0507-49ef-8320-e063-6294a90ae39f", "openfda": {"upc": ["0300450209269"], "unii": ["64O047KTOA"], "rxcui": ["1014673", "1020021"], "spl_set_id": ["9d8e78ea-af98-4f7c-8db5-044b49582f80"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-730-01)  / 30 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50580-730-01", "marketing_start_date": "20170116"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-730-05)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50580-730-05", "marketing_start_date": "20150713"}, {"sample": false, "description": "2 CARTON in 1 PACKAGE (50580-730-06)  / 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50580-730-06", "marketing_start_date": "20150731"}, {"sample": false, "description": "3 TRAY in 1 PACKAGE (50580-730-17)  / 1 BOTTLE in 1 TRAY / 118 mL in 1 BOTTLE", "package_ndc": "50580-730-17", "marketing_start_date": "20181203"}, {"sample": false, "description": "2 CARTON in 1 PACKAGE (50580-730-18)  / 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE", "package_ndc": "50580-730-18", "marketing_start_date": "20181203"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-730-19)  / 240 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50580-730-19", "marketing_start_date": "20200616"}], "brand_name": "Childrens Zyrtec", "product_id": "50580-730_40cb0507-49ef-8320-e063-6294a90ae39f", "dosage_form": "SYRUP", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-730", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Zyrtec", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "NDA022155", "marketing_category": "NDA", "marketing_start_date": "20090601", "listing_expiration_date": "20261231"}