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Fexofenadine Hydrochloride

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
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
14
Packages
29
Data completeness
83% 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 180 mg/1 997501 View
Fexofenadine Hydrochloride 30 mg/1 997501 View
Fexofenadine Hydrochloride 60 mg/1 997501 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
43

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
202039
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 19, 2014
Sponsor
AUROBINDO PHARMA LTD
Products on application
3
Submissions recorded
2
Products approved under application 202039.
Product Trade name Form Strength Ingredient Status TE Flags
202039-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
202039-002 FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
202039-003 FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 202039.
Type No. Action Status Date Review
Supplement 3 Manufacturing (CMC) Approved September 15, 2017 Unknown
Original application 1 Not Applicable Approved November 19, 2014 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260806). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260806 HUMAN OTC DRUG · 20260615 HUMAN OTC DRUG · 20241213 HUMAN OTC DRUG · 20220222

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 Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years of age and over take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours children 6 to under 12 years of age take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 6 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Warnings Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking wheezing or problems breathing drooling These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. Do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks If pregnant or breast-feeding, 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.

Do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. 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. hives that are an unusual color, look bruised or blistered hives that do not itch

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

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Fexofenadine HCl USP, 60 mg (for 60 mg) Fexofenadine HCl USP, 180 mg (for 180 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.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II January 31, 2024 SUN PHARMACEUTICAL INDUSTRIES INC CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Completed
Class II July 19, 2023 L. Perrigo Company Failed Impurities/Degradation Specifications Terminated

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
10202-229-66 10202-229 7-eleven 1 BLISTER PACK in 1 CARTON (10202-229-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK January 15, 2015
46122-779-58 46122-779 AMERISOURCE BERGEN 3 BLISTER PACK in 1 CARTON (46122-779-58) / 5 TABLET, FILM COATED in 1 BLISTER PACK May 14, 2024
46122-779-61 46122-779 AMERISOURCE BERGEN 1 BOTTLE in 1 CARTON (46122-779-61) / 30 TABLET, FILM COATED in 1 BOTTLE May 14, 2024
46122-779-66 46122-779 AMERISOURCE BERGEN 1 BOTTLE in 1 CARTON (46122-779-66) / 90 TABLET, FILM COATED in 1 BOTTLE May 14, 2024
73629-008-03 73629-008 AMZ789 LLC 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73629-008-03) July 27, 2024
58602-876-09 58602-876 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-876-09) / 30 TABLET, FILM COATED in 1 BOTTLE October 13, 2023
58602-876-40 58602-876 Aurohealth LLC 500 TABLET, FILM COATED in 1 BOTTLE (58602-876-40) October 13, 2023
58602-876-60 58602-876 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-876-60) / 5 TABLET, FILM COATED in 1 BLISTER PACK October 13, 2023
58602-877-09 58602-877 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-877-09) / 30 TABLET, FILM COATED in 1 BOTTLE October 13, 2023
58602-877-40 58602-877 Aurohealth LLC 500 TABLET, FILM COATED in 1 BOTTLE (58602-877-40) October 13, 2023
58602-877-74 58602-877 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-877-74) / 6 TABLET, FILM COATED in 1 BLISTER PACK October 13, 2023
58602-878-09 58602-878 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-878-09) / 30 TABLET, FILM COATED in 1 BOTTLE October 13, 2023
58602-878-40 58602-878 Aurohealth LLC 500 TABLET, FILM COATED in 1 BOTTLE (58602-878-40) October 13, 2023
58602-878-60 58602-878 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-878-60) / 5 TABLET, FILM COATED in 1 BLISTER PACK October 13, 2023
62207-889-49 62207-889 Granules India Limited 1000 TABLET, FILM COATED in 1 BOTTLE (62207-889-49) November 7, 2023
62207-889-51 62207-889 Granules India Limited 1 BOTTLE in 1 CARTON (62207-889-51) / 10 TABLET, FILM COATED in 1 BOTTLE November 7, 2023
62207-889-60 62207-889 Granules India Limited 8 BLISTER PACK in 1 CARTON (62207-889-60) / 9 TABLET, FILM COATED in 1 BLISTER PACK November 7, 2023
62207-891-49 62207-891 Granules India Limited 1000 TABLET, FILM COATED in 1 BOTTLE (62207-891-49) November 7, 2023
62207-891-51 62207-891 Granules India Limited 1 BOTTLE in 1 CARTON (62207-891-51) / 10 TABLET, FILM COATED in 1 BOTTLE November 7, 2023
62207-891-58 62207-891 Granules India Limited 7 BLISTER PACK in 1 CARTON (62207-891-58) / 10 TABLET, FILM COATED in 1 BLISTER PACK November 7, 2023
0615-8648-39 0615-8648 NCS HealthCare of KY, LLC dba Vangard Labs 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8648-39) June 23, 2026
51660-998-30 51660-998 OHM LABORATORIES INC. 1 BOTTLE in 1 CARTON (51660-998-30) / 30 TABLET, FILM COATED in 1 BOTTLE April 29, 2022
51660-998-55 51660-998 OHM LABORATORIES INC. 1 BOTTLE in 1 CARTON (51660-998-55) / 150 TABLET, FILM COATED in 1 BOTTLE April 29, 2022
45802-847-78 45802-847 Padagis Israel Pharmaceuticals Ltd 1 BOTTLE in 1 CARTON (45802-847-78) / 100 TABLET, FILM COATED in 1 BOTTLE January 7, 2022
71205-739-30 71205-739 Proficient Rx LP 30 TABLET, FILM COATED in 1 BOTTLE (71205-739-30) December 28, 2022
71205-739-60 71205-739 Proficient Rx LP 60 TABLET, FILM COATED in 1 BOTTLE (71205-739-60) December 28, 2022
71205-739-90 71205-739 Proficient Rx LP 90 TABLET, FILM COATED in 1 BOTTLE (71205-739-90) December 28, 2022
68210-2210-1 68210-2210 SPIRIT PHARMACEUTICALS LLC 100 TABLET, FILM COATED in 1 PACKAGE (68210-2210-1) March 17, 2020
68210-4090-1 68210-4090 SPIRIT PHARMACEUTICALS LLC 100 TABLET, FILM COATED in 1 PACKAGE (68210-4090-1) July 2, 2020
10202-229 10202-229 7-eleven — January 15, 2015
46122-779 46122-779 AMERISOURCE BERGEN — May 14, 2024
73629-008 73629-008 AMZ789 LLC — July 27, 2024
58602-876 58602-876 Aurohealth LLC — October 13, 2023
58602-877 58602-877 Aurohealth LLC — October 13, 2023
58602-878 58602-878 Aurohealth LLC — October 13, 2023
62207-889 62207-889 Granules India Limited — November 7, 2023
62207-891 62207-891 Granules India Limited — November 7, 2023
0615-8648 0615-8648 NCS HealthCare of KY, LLC dba Vangard Labs — April 29, 2022
51660-998 51660-998 OHM LABORATORIES INC. — April 29, 2022
45802-847 45802-847 Padagis Israel Pharmaceuticals Ltd — January 7, 2022
71205-739 71205-739 Proficient Rx LP — January 7, 2022
68210-2210 68210-2210 SPIRIT PHARMACEUTICALS LLC — March 17, 2020
68210-4090 68210-4090 SPIRIT PHARMACEUTICALS LLC — July 2, 2020

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
Enforcement FDA Recall records

Generated September 25, 2026 · 12 sections on this page.