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Childrens Cetirizine Hydrochloride Hives Relief

Cetirizine Hydrochloride · Solution

Over-the-counter ANDA
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
Childrens Cetirizine Hydrochloride Hives Relief
Generic name
Cetirizine Hydrochloride
Dosage form
Solution
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
6
Data completeness
54% 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 1 mg/mL 1014678 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Oral
Presentations
8

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
090750
Application type
ANDA · Abbreviated New Drug Application
Approval date
February 2, 2010
Sponsor
AUROBINDO PHARMA
Products on application
2
Submissions recorded
2
Products approved under application 090750.
Product Trade name Form Strength Ingredient Status TE Flags
090750-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF SOLUTION CETIRIZINE HYDROCHLORIDE Over-the-counter —
090750-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY SOLUTION CETIRIZINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 090750.
Type No. Action Status Date Review
Supplement 3 Manufacturing (CMC) Approved June 24, 2015 Unknown
Original application 1 Approved February 2, 2010 —

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
58602-030-20 58602-030 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-030-20) / 240 mL in 1 BOTTLE June 24, 2015
58602-030-24 58602-030 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-030-24) / 120 mL in 1 BOTTLE June 24, 2015
58602-030-26 58602-030 Aurohealth LLC 480 mL in 1 BOTTLE (58602-030-26) June 24, 2015
58602-036-15 58602-036 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-036-15) / 120 mL in 1 BOTTLE February 2, 2010
58602-036-16 58602-036 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-036-16) / 240 mL in 1 BOTTLE February 2, 2010
58602-036-17 58602-036 Aurohealth LLC 480 mL in 1 BOTTLE (58602-036-17) February 2, 2010
58602-030 58602-030 Aurohealth LLC — June 24, 2015
58602-036 58602-036 Aurohealth LLC — February 2, 2010

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
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 9 sections on this page.