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fexofenadine hcl

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 hcl
Generic name
fexofenadine hcl
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Camber Consumer Care
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
15
Packages
50
Data completeness
82% 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 60 mg/1 997501 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
65

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
204507
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 16, 2015
Sponsor
SCIEGEN PHARMS
Products on application
4
Submissions recorded
1
Products approved under application 204507.
Product Trade name Form Strength Ingredient Status TE Flags
204507-002 FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
204507-003 FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
204507-004 FEXOFENADINE HYDROCHLORIDE HIVES TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
204507-005 FEXOFENADINE HYDROCHLORIDE HIVES TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 204507.
Type No. Action Status Date Review
Original application 1 Approved September 16, 2015 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251022). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251022 HUMAN OTC DRUG · 20241224

Indications and Usage

openFDA Drug Labeling

Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

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 Antihistamine

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions (for 60mg) adults and children 12 years of age and over take one 60mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Directions (for 180mg) adults and children 12 years of age and over take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Directions (for 60mg) adults and children 12 years of age and over take one 60mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Directions (for 180mg) adults and children 12 years of age and over take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 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 drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health profession 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.

Warnings Do not use 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. 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. 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

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. hives that are an unusual color, look bruised or blistered hives that do not itch

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

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

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

Active Ingredient

openFDA Drug Labeling

HIVES Active ingredient (in each film-coated tablet) Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg

ALLERGY Active ingredient (in each film-coated tablet) Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Fexofenadine Hydrochloride 60mg Tablets NDC 71335-2165-1: 30 Tablets in a BOTTLE NDC 71335-2165-2: 10 Tablets in a BOTTLE NDC 71335-2165-3: 60 Tablets in a BOTTLE NDC 71335-2165-4: 90 Tablets in a BOTTLE NDC 71335-2165-5: 14 Tablets in a BOTTLE NDC 71335-2165-6: 20 Tablets in a BOTTLE NDC 71335-2165-7: 12 Tablets in a BOTTLE store between 20° and 25°C (68° and 77°F). protect from excessive moisture. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

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
71399-8659-1 71399-8659 AKRON PHARMA INC 100 TABLET, FILM COATED in 1 BOTTLE (71399-8659-1) November 1, 2021
71399-8659-5 71399-8659 AKRON PHARMA INC 500 TABLET, FILM COATED in 1 BOTTLE (71399-8659-5) February 2, 2024
80513-506-01 80513-506 Advanced Rx LLC 100 TABLET, FILM COATED in 1 BOTTLE (80513-506-01) September 10, 2024
71610-893-53 71610-893 Aphena Pharma Solutions - Tennessee, LLC 60 TABLET, FILM COATED in 1 BOTTLE (71610-893-53) April 2, 2025
71610-893-60 71610-893 Aphena Pharma Solutions - Tennessee, LLC 90 TABLET, FILM COATED in 1 BOTTLE (71610-893-60) April 2, 2025
71610-893-70 71610-893 Aphena Pharma Solutions - Tennessee, LLC 120 TABLET, FILM COATED in 1 BOTTLE (71610-893-70) April 2, 2025
71610-905-30 71610-905 Aphena Pharma Solutions - Tennessee, LLC 30 TABLET, FILM COATED in 1 BOTTLE (71610-905-30) May 7, 2025
71610-905-53 71610-905 Aphena Pharma Solutions - Tennessee, LLC 60 TABLET, FILM COATED in 1 BOTTLE (71610-905-53) May 7, 2025
71610-905-60 71610-905 Aphena Pharma Solutions - Tennessee, LLC 90 TABLET, FILM COATED in 1 BOTTLE (71610-905-60) May 7, 2025
71610-905-80 71610-905 Aphena Pharma Solutions - Tennessee, LLC 180 TABLET, FILM COATED in 1 BOTTLE (71610-905-80) May 7, 2025
71335-2165-1 71335-2165 Bryant Ranch Prepack 30 TABLET, FILM COATED in 1 BOTTLE (71335-2165-1) September 6, 2024
71335-2165-2 71335-2165 Bryant Ranch Prepack 10 TABLET, FILM COATED in 1 BOTTLE (71335-2165-2) August 25, 2022
71335-2165-3 71335-2165 Bryant Ranch Prepack 60 TABLET, FILM COATED in 1 BOTTLE (71335-2165-3) September 6, 2024
71335-2165-4 71335-2165 Bryant Ranch Prepack 90 TABLET, FILM COATED in 1 BOTTLE (71335-2165-4) September 6, 2024
71335-2165-5 71335-2165 Bryant Ranch Prepack 14 TABLET, FILM COATED in 1 BOTTLE (71335-2165-5) September 6, 2024
71335-2165-6 71335-2165 Bryant Ranch Prepack 20 TABLET, FILM COATED in 1 BOTTLE (71335-2165-6) September 6, 2024
71335-2165-7 71335-2165 Bryant Ranch Prepack 12 TABLET, FILM COATED in 1 BOTTLE (71335-2165-7) November 8, 2022
69230-201-01 69230-201 Camber Consumer Care 100 TABLET, FILM COATED in 1 BOTTLE (69230-201-01) December 8, 2021
69230-201-05 69230-201 Camber Consumer Care 500 TABLET, FILM COATED in 1 BOTTLE (69230-201-05) December 8, 2021
69230-202-01 69230-202 Camber Consumer Care 1 BOTTLE in 1 CARTON (69230-202-01) / 100 TABLET, FILM COATED in 1 BOTTLE September 16, 2015
69230-202-05 69230-202 Camber Consumer Care 500 TABLET, FILM COATED in 1 BOTTLE (69230-202-05) September 16, 2015
69230-202-11 69230-202 Camber Consumer Care 1000 TABLET, FILM COATED in 1 BOTTLE (69230-202-11) September 16, 2015
69230-202-30 69230-202 Camber Consumer Care 1 BOTTLE in 1 CARTON (69230-202-30) / 30 TABLET, FILM COATED in 1 BOTTLE September 16, 2015
69230-202-45 69230-202 Camber Consumer Care 1 BOTTLE in 1 CARTON (69230-202-45) / 45 TABLET, FILM COATED in 1 BOTTLE September 16, 2015
69230-202-60 69230-202 Camber Consumer Care 1 BOTTLE in 1 CARTON (69230-202-60) / 60 TABLET, FILM COATED in 1 BOTTLE September 16, 2015
69230-202-90 69230-202 Camber Consumer Care 1 BOTTLE in 1 CARTON (69230-202-90) / 90 TABLET, FILM COATED in 1 BOTTLE September 16, 2015
0904-7192-04 0904-7192 Major Pharmaceuticals 100 TABLET, FILM COATED in 1 BOTTLE (0904-7192-04) August 20, 2024
0904-7192-40 0904-7192 Major Pharmaceuticals 500 TABLET, FILM COATED in 1 BOTTLE (0904-7192-40) August 26, 2021
0904-7192-60 0904-7192 Major Pharmaceuticals 100 TABLET, FILM COATED in 1 BOTTLE (0904-7192-60) August 26, 2021
0904-7486-02 0904-7486 Major Pharmaceuticals 30 TABLET, FILM COATED in 1 BOTTLE (0904-7486-02) August 20, 2024
0904-7486-40 0904-7486 Major Pharmaceuticals 500 TABLET, FILM COATED in 1 BOTTLE (0904-7486-40) August 20, 2024
0904-7486-60 0904-7486 Major Pharmaceuticals 100 TABLET, FILM COATED in 1 BOTTLE (0904-7486-60) August 20, 2024
63187-921-20 63187-921 Proficient Rx LP 20 TABLET, FILM COATED in 1 BOTTLE (63187-921-20) October 2, 2017
63187-921-30 63187-921 Proficient Rx LP 30 TABLET, FILM COATED in 1 BOTTLE (63187-921-30) October 2, 2017
63187-921-60 63187-921 Proficient Rx LP 60 TABLET, FILM COATED in 1 BOTTLE (63187-921-60) October 2, 2017
63187-921-90 63187-921 Proficient Rx LP 90 TABLET, FILM COATED in 1 BOTTLE (63187-921-90) October 2, 2017
77771-201-01 77771-201 Radha Pharmaceuticals 100 TABLET, FILM COATED in 1 BOTTLE (77771-201-01) March 10, 2025
77771-201-05 77771-201 Radha Pharmaceuticals 500 TABLET, FILM COATED in 1 BOTTLE (77771-201-05) March 10, 2025
77771-202-01 77771-202 Radha Pharmaceuticals 100 TABLET, FILM COATED in 1 BOTTLE (77771-202-01) March 10, 2025
77771-202-05 77771-202 Radha Pharmaceuticals 500 TABLET, FILM COATED in 1 BOTTLE (77771-202-05) March 10, 2025
77771-202-30 77771-202 Radha Pharmaceuticals 30 TABLET, FILM COATED in 1 BOTTLE (77771-202-30) March 10, 2025
50228-201-01 50228-201 ScieGen Pharmaceuticals, Inc. 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-01) December 26, 2014
50228-201-02 50228-201 ScieGen Pharmaceuticals, Inc. 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-02) December 26, 2014
50228-201-03 50228-201 ScieGen Pharmaceuticals, Inc. 30 TABLET, FILM COATED in 1 BOTTLE (50228-201-03) December 26, 2014
50228-201-04 50228-201 ScieGen Pharmaceuticals, Inc. 1000 TABLET, FILM COATED in 1 BOTTLE (50228-201-04) December 26, 2014
50228-202-01 50228-202 ScieGen Pharmaceuticals, Inc. 30 TABLET, FILM COATED in 1 BOTTLE (50228-202-01) December 26, 2014
50228-202-02 50228-202 ScieGen Pharmaceuticals, Inc. 1000 TABLET, FILM COATED in 1 BOTTLE (50228-202-02) December 26, 2014
50228-202-03 50228-202 ScieGen Pharmaceuticals, Inc. 30 TABLET, FILM COATED in 1 BOTTLE (50228-202-03) December 26, 2014
50228-202-04 50228-202 ScieGen Pharmaceuticals, Inc. 1000 TABLET, FILM COATED in 1 BOTTLE (50228-202-04) December 26, 2014
70677-1239-1 70677-1239 Strategic Sourcing Services, LLC 100 TABLET, FILM COATED in 1 BOTTLE (70677-1239-1) February 22, 2024
71399-8659 71399-8659 AKRON PHARMA INC — December 26, 2014
80513-506 80513-506 Advanced Rx LLC — September 16, 2015
71610-893 71610-893 Aphena Pharma Solutions - Tennessee, LLC — August 20, 2024
71610-905 71610-905 Aphena Pharma Solutions - Tennessee, LLC — March 10, 2025
71335-2165 71335-2165 Bryant Ranch Prepack — August 26, 2021
69230-201 69230-201 Camber Consumer Care — December 8, 2021
69230-202 69230-202 Camber Consumer Care — September 16, 2015
0904-7192 0904-7192 Major Pharmaceuticals — August 26, 2021
0904-7486 0904-7486 Major Pharmaceuticals — August 20, 2024
63187-921 63187-921 Proficient Rx LP — September 16, 2015
77771-201 77771-201 Radha Pharmaceuticals — March 10, 2025
77771-202 77771-202 Radha Pharmaceuticals — March 10, 2025
50228-201 50228-201 ScieGen Pharmaceuticals, Inc. — December 26, 2014
50228-202 50228-202 ScieGen Pharmaceuticals, Inc. — December 26, 2014
70677-1239 70677-1239 Strategic Sourcing Services, LLC — February 22, 2024

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.