childrens zyrtec allergy

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

Brand Name childrens zyrtec allergy
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 50580-721
Product ID 50580-721_48bb7dd3-c2b8-ecfb-e063-6294a90af77d
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022155
Listing Expiration 2027-12-31
Marketing Start 2009-01-20

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 50580721
Hyphenated Format 50580-721

Supplemental Identifiers

RxCUI
1014673 1020021
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 allergy (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 (50580-721-05) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50580-721-05 1 BOTTLE, PLASTIC in 1 CARTON (50580-721-05) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Childrens Zyrtec Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48bb7dd3-c2b8-ecfb-e063-6294a90af77d", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673", "1020021"], "spl_set_id": ["ee8695ac-1293-4e43-ac7c-a64e21a0ca0a"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-721-05)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50580-721-05", "marketing_start_date": "20150713"}], "brand_name": "Childrens Zyrtec Allergy", "product_id": "50580-721_48bb7dd3-c2b8-ecfb-e063-6294a90af77d", "dosage_form": "SYRUP", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-721", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Zyrtec Allergy", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "NDA022155", "marketing_category": "NDA", "marketing_start_date": "20090120", "listing_expiration_date": "20271231"}