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Fexofenadine Hydrochloride

Fexofenadine Hydrochloride Oral · Suspension

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
Fexofenadine Hydrochloride
Generic name
Fexofenadine Hydrochloride Oral
Dosage form
Suspension
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
4
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
Fexofenadine Hydrochloride 30 mg/5mL 997501 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Suspension
Route of administration
Oral
Presentations
6

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
213466
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 23, 2023
Sponsor
AUROBINDO PHARMA LTD
Products on application
1
Submissions recorded
2
Products approved under application 213466.
Product Trade name Form Strength Ingredient Status TE Flags
213466-001 FEXOFENADINE HYDROCHLORIDE SUSPENSION FEXOFENADINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 213466.
Type No. Action Status Date Review
Supplement 1 Manufacturing (CMC) Approved August 31, 2026 Unknown
Original application 1 Approved May 23, 2023 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20230606). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20230606

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions shake well before using use only with enclosed dosing cup adults and children 12 years of age and over take 10 mL every 12 hours; do not take more than 20 mL in 24 hours children 2 to under 12 years of age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours children under 2 years of age ask a doctor adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor Note: mL = milliliters

Warnings

openFDA Drug Labeling

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a Doctor

openFDA Drug Labeling

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

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

Drug Facts Active ingredient (in each 5 mL) Fexofenadine Hydrochloride USP 30 mg

Adverse event reports

Source: openFDA FAERS
21,660
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: FEXOFENADINE 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
58602-426-20 58602-426 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-426-20) / 240 mL in 1 BOTTLE May 23, 2023
58602-426-24 58602-426 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-426-24) / 120 mL in 1 BOTTLE May 23, 2023
58602-427-20 58602-427 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-427-20) / 240 mL in 1 BOTTLE August 31, 2026
58602-427-24 58602-427 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-427-24) / 120 mL in 1 BOTTLE August 31, 2026
58602-426 58602-426 Aurohealth LLC — May 23, 2023
58602-427 58602-427 Aurohealth LLC — August 31, 2026

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 · 11 sections on this page.