topcare all day allergy (36800-448)

Drug Facts

Product Profile

Brand Name topcare all day allergy

Generic Name cetirizine hydrochloride

Labeler topco associates llc

Dosage Form CAPSULE, LIQUID FILLED

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer

Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-448

Product ID 36800-448_eb748140-aec8-4fcf-9597-20610d87635a

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA213105

Listing Expiration 2026-12-31

Marketing Start 2022-02-28

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 36800448

Hyphenated Format 36800-448

Supplemental Identifiers

RxCUI

1014675

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 all day allergy (source: ndc)

Generic Name cetirizine hydrochloride (source: ndc)

Application Number ANDA213105 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

1 BOTTLE in 1 PACKAGE (36800-448-09) / 65 CAPSULE, LIQUID FILLED in 1 BOTTLE
1 BOTTLE in 1 PACKAGE (36800-448-49) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
1 BOTTLE in 1 PACKAGE (36800-448-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE

source: ndc

Packages (3)

36800-448-09 1 BOTTLE in 1 PACKAGE (36800-448-09) / 65 CAPSULE, LIQUID FILLED in 1 BOTTLE 36800-448-49 1 BOTTLE in 1 PACKAGE (36800-448-49) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE 36800-448-63 1 BOTTLE in 1 PACKAGE (36800-448-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

topcare all day allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "eb748140-aec8-4fcf-9597-20610d87635a", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014675"], "spl_set_id": ["10c512a1-bb96-4d2a-9e41-a422efb57e28"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 PACKAGE (36800-448-09)  / 65 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "36800-448-09", "marketing_start_date": "20220228"}, {"sample": false, "description": "1 BOTTLE in 1 PACKAGE (36800-448-49)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "36800-448-49", "marketing_start_date": "20230203"}, {"sample": false, "description": "1 BOTTLE in 1 PACKAGE (36800-448-63)  / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "36800-448-63", "marketing_start_date": "20220228"}], "brand_name": "topcare all day allergy", "product_id": "36800-448_eb748140-aec8-4fcf-9597-20610d87635a", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-448", "generic_name": "cetirizine hydrochloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare all day allergy", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA213105", "marketing_category": "ANDA", "marketing_start_date": "20220228", "listing_expiration_date": "20261231"}