topcare childrens all day allergy

Generic: cetirizine hcl

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare childrens all day allergy
Generic Name cetirizine hcl
Labeler topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/5mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-475
Product ID 36800-475_11d505ff-696b-462c-8952-0c73491de9f4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204226
Listing Expiration 2026-12-31
Marketing Start 2016-02-02

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 36800475
Hyphenated Format 36800-475

Supplemental Identifiers

RxCUI
1014673
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 topcare childrens all day allergy (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
  • 1 BOTTLE in 1 CARTON (36800-475-00) / 240 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-475-26) / 118 mL in 1 BOTTLE
source: ndc

Packages (2)

36800-475-00 1 BOTTLE in 1 CARTON (36800-475-00) / 240 mL in 1 BOTTLE 36800-475-26 1 BOTTLE in 1 CARTON (36800-475-26) / 118 mL in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

TopCare Childrens All Day Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "11d505ff-696b-462c-8952-0c73491de9f4", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["48555c1f-8c2a-4ab2-9af3-d2488ca509e4"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-475-00)  / 240 mL in 1 BOTTLE", "package_ndc": "36800-475-00", "marketing_start_date": "20211101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-475-26)  / 118 mL in 1 BOTTLE", "package_ndc": "36800-475-26", "marketing_start_date": "20160202"}], "brand_name": "TopCare Childrens All Day Allergy", "product_id": "36800-475_11d505ff-696b-462c-8952-0c73491de9f4", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-475", "generic_name": "Cetirizine HCl", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare Childrens All Day Allergy", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA204226", "marketing_category": "ANDA", "marketing_start_date": "20160202", "listing_expiration_date": "20261231"}