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Topcare All Day Allergy

levocetirizine dihydrochloride · Tablet, Film Coated

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Topcare All Day Allergy
Generic name
levocetirizine dihydrochloride
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Topco Associates LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
10
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Cetirizine Hydrochloride 10 mg/1 1014678 View
Levocetirizine Dihydrochloride 5 mg/1 855172 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
211983
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 28, 2019
Sponsor
PERRIGO R AND D
Products on application
1
Submissions recorded
3
Products approved under application 211983.
Product Trade name Form Strength Ingredient Status TE Flags
211983-001 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET LEVOCETIRIZINE DIHYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 211983.
Type No. Action Status Date Review
Supplement 3 Manufacturing (CMC) Approved December 31, 2019 Unknown
Supplement 1 Manufacturing (CMC) Approved October 21, 2019 Unknown
Original application 1 Approved March 28, 2019 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251223). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251223 HUMAN OTC DRUG · 20220221

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions adults 65 years of age and older • ask a doctor adults and children 12-64 years of age • take 1 tablet (5 mg) once daily in the evening • do not take more than 1 tablet (5 mg) in 24 hours • 1⁄2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age • take 1⁄2 tablet (2.5 mg) once daily in the evening • do not take more than 1⁄2 tablet (2.5 mg) in 24 hours children under 6 years of age • do not use consumers with kidney disease • do not use

Warnings

openFDA Drug Labeling

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do Not Use

openFDA Drug Labeling

Do not use • if you have kidney disease • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if • you have trouble urinating or emptying your bladder • an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Levocetirizine dihydrochloride 5 mg

Adverse event reports

Source: openFDA FAERS
166,303
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CETIRIZINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
36800-241-01 36800-241 Topco Associates LLC 1 BOTTLE in 1 CARTON (36800-241-01) / 35 TABLET, FILM COATED in 1 BOTTLE February 5, 2020
36800-241-46 36800-241 Topco Associates LLC 10 BLISTER PACK in 1 CARTON (36800-241-46) / 1 TABLET, FILM COATED in 1 BLISTER PACK March 9, 2020
36800-241-95 36800-241 Topco Associates LLC 1 BOTTLE in 1 CARTON (36800-241-95) / 45 TABLET, FILM COATED in 1 BOTTLE October 7, 2020
36800-458-39 36800-458 Topco Associates LLC 1 BOTTLE in 1 CARTON (36800-458-39) / 30 TABLET, FILM COATED in 1 BOTTLE April 16, 2009
36800-458-47 36800-458 Topco Associates LLC 1 BOTTLE in 1 CARTON (36800-458-47) / 150 TABLET, FILM COATED in 1 BOTTLE May 26, 2010
36800-458-66 36800-458 Topco Associates LLC 14 BLISTER PACK in 1 CARTON (36800-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK January 10, 2008
36800-458-72 36800-458 Topco Associates LLC 1 BOTTLE in 1 CARTON (36800-458-72) / 60 TABLET, FILM COATED in 1 BOTTLE January 28, 2008
36800-458-75 36800-458 Topco Associates LLC 1 BOTTLE in 1 CARTON (36800-458-75) / 90 TABLET, FILM COATED in 1 BOTTLE September 19, 2008
36800-458-87 36800-458 Topco Associates LLC 1 BOTTLE in 1 CARTON (36800-458-87) / 300 TABLET, FILM COATED in 1 BOTTLE April 28, 2010
36800-458-95 36800-458 Topco Associates LLC 1 BOTTLE in 1 CARTON (36800-458-95) / 45 TABLET, FILM COATED in 1 BOTTLE September 8, 2009
36800-241 36800-241 Topco Associates LLC — February 5, 2020
36800-458 36800-458 Topco Associates LLC — January 10, 2008

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.