kirkland signature childrens aller tec

Generic: cetirizine hcl

Labeler: costco wholesale company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name kirkland signature childrens aller tec
Generic Name cetirizine hcl
Labeler costco wholesale company
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/5mL

Manufacturer
Costco Wholesale Company

Identifiers & Regulatory

Product NDC 63981-475
Product ID 63981-475_fcdbe753-6a33-4c46-acfe-3ead668364ec
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204226
Listing Expiration 2026-12-31
Marketing Start 2016-07-08

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 63981475
Hyphenated Format 63981-475

Supplemental Identifiers

RxCUI
1014673 1020017
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 kirkland signature childrens aller tec (source: ndc)
Generic Name cetirizine hcl (source: ndc)
Application Number ANDA204226 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 2 BOTTLE in 1 CARTON (63981-475-43) / 240 mL in 1 BOTTLE (63981-475-34)
source: ndc

Packages (1)

63981-475-43 2 BOTTLE in 1 CARTON (63981-475-43) / 240 mL in 1 BOTTLE (63981-475-34)

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Kirkland Signature Childrens Aller Tec ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fcdbe753-6a33-4c46-acfe-3ead668364ec", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673", "1020017"], "spl_set_id": ["eb14a311-7918-4c4b-ae05-7606cfb8a4af"], "manufacturer_name": ["Costco Wholesale Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (63981-475-43)  / 240 mL in 1 BOTTLE (63981-475-34)", "package_ndc": "63981-475-43", "marketing_start_date": "20160708"}], "brand_name": "Kirkland Signature Childrens Aller Tec", "product_id": "63981-475_fcdbe753-6a33-4c46-acfe-3ead668364ec", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "63981-475", "generic_name": "Cetirizine HCl", "labeler_name": "Costco Wholesale Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Kirkland Signature Childrens Aller Tec", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA204226", "marketing_category": "ANDA", "marketing_start_date": "20160708", "listing_expiration_date": "20261231"}