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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
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Rite Aid
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
31
Packages
76
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
Route of administration
Oral
Presentations
107

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
204097
Application type
ANDA · Abbreviated New Drug Application
Approval date
August 19, 2016
Sponsor
HETERO LABS LTD V
Products on application
3
Submissions recorded
1
Products approved under application 204097.
Product Trade name Form Strength Ingredient Status TE Flags
204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —
204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY TABLET FEXOFENADINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 204097.
Type No. Action Status Date Review
Original application 1 Approved August 19, 2016 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260416). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260416 HUMAN OTC DRUG · 20251219 HUMAN OTC DRUG · 20251219 HUMAN OTC DRUG · 20251008

Indications and Usage

openFDA Drug Labeling

USE(S) 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

Dosage and Administration

openFDA Drug Labeling

DIRECTIONS 60 mg adults and children 12 years of age and over take one 60 mg 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 180 mg adults and children 12 years of age and over take one 180 mg 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

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

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.  symptoms do not improve after 3 days of treatment  the hives have lasted more than 6 weeks

Active Ingredient

openFDA Drug Labeling

ACTIVE INGREDIENT(S), in each tablet Fexofenadine hydrochloride USP, 180 mg

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Fexofenadine HCL, 180 mg are pink, capsules debossed with 'J 44' and are supplied as follows: NDC 72789-196-10 in bottles of 10 tablets NDC 72789-196-30 in bottles of 30 tablets NDC 72789-196-90 in bottles of 90 tablets

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
50090-4070-0 50090-4070 A-S Medication Solutions 30 TABLET in 1 BOTTLE (50090-4070-0) January 18, 2019
50090-4070-1 50090-4070 A-S Medication Solutions 90 TABLET in 1 BOTTLE (50090-4070-1) January 18, 2019
50090-4070-2 50090-4070 A-S Medication Solutions 100 TABLET in 1 BOTTLE (50090-4070-2) October 4, 2021
50090-4267-0 50090-4267 A-S Medication Solutions 30 TABLET in 1 BOTTLE (50090-4267-0) April 18, 2019
50090-6965-0 50090-6965 A-S Medication Solutions 1 BOTTLE in 1 CARTON (50090-6965-0) / 30 TABLET in 1 BOTTLE December 20, 2023
71399-8042-1 71399-8042 Akron Pharma Inc. 100 TABLET in 1 BOTTLE (71399-8042-1) September 9, 2020
71399-8042-3 71399-8042 Akron Pharma Inc. 30 TABLET in 1 BOTTLE (71399-8042-3) August 9, 2024
71335-1217-1 71335-1217 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1217-1) May 14, 2019
71335-1217-2 71335-1217 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-1217-2) May 14, 2019
71335-1217-3 71335-1217 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1217-3) May 14, 2019
71335-1217-4 71335-1217 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1217-4) May 14, 2019
71335-1217-5 71335-1217 Bryant Ranch Prepack 5 TABLET in 1 BOTTLE (71335-1217-5) May 14, 2019
71335-1217-6 71335-1217 Bryant Ranch Prepack 180 TABLET in 1 BOTTLE (71335-1217-6) May 14, 2019
71335-1217-7 71335-1217 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-1217-7) May 14, 2019
51316-767-03 51316-767 CVS 30 TABLET in 1 BOTTLE (51316-767-03) March 27, 2024
51316-768-06 51316-768 CVS 60 TABLET in 1 BOTTLE (51316-768-06) January 1, 2024
69230-300-01 69230-300 Camber Consumer Care 1 BOTTLE in 1 CARTON (69230-300-01) / 100 TABLET in 1 BOTTLE August 19, 2016
69230-300-05 69230-300 Camber Consumer Care 500 TABLET in 1 BOTTLE (69230-300-05) August 19, 2016
69230-300-30 69230-300 Camber Consumer Care 1 BOTTLE in 1 CARTON (69230-300-30) / 30 TABLET in 1 BOTTLE August 19, 2016
69230-301-01 69230-301 Camber Consumer Care 1 BOTTLE in 1 CARTON (69230-301-01) / 100 TABLET in 1 BOTTLE August 19, 2016
69230-301-30 69230-301 Camber Consumer Care 1 BOTTLE in 1 CARTON (69230-301-30) / 30 TABLET in 1 BOTTLE August 19, 2016
69230-300-00 69230-300 Camber Consumer Care Inc 3 BAG in 1 DRUM (69230-300-00) / 10000 TABLET in 1 BAG August 19, 2016
70010-183-03 70010-183 GRANULES PHARMACEUTICALS INC. 30 TABLET in 1 BOTTLE (70010-183-03) April 25, 2023
79481-7660-4 79481-7660 Meijer 45 TABLET in 1 BOTTLE (79481-7660-4) September 9, 2024
79481-6230-2 79481-6230 Meijer, Inc. 24 TABLET in 1 BOTTLE (79481-6230-2) August 1, 2025
79481-6230-6 79481-6230 Meijer, Inc. 60 TABLET in 1 BOTTLE (79481-6230-6) July 1, 2024
16714-899-01 16714-899 NorthStar RxLLC 1 BOTTLE in 1 CARTON (16714-899-01) / 30 TABLET in 1 BOTTLE February 18, 2019
16714-899-02 16714-899 NorthStar RxLLC 1 BOTTLE in 1 CARTON (16714-899-02) / 100 TABLET in 1 BOTTLE February 18, 2019
51655-854-26 51655-854 Northwind Health Company, LLC 90 TABLET in 1 BOTTLE, PLASTIC (51655-854-26) February 7, 2023
51655-854-52 51655-854 Northwind Health Company, LLC 30 TABLET in 1 BOTTLE, PLASTIC (51655-854-52) December 19, 2025
72789-196-10 72789-196 PD-Rx Pharmaceuticals, Inc. 10 TABLET in 1 BOTTLE, PLASTIC (72789-196-10) March 14, 2023
72789-196-30 72789-196 PD-Rx Pharmaceuticals, Inc. 30 TABLET in 1 BOTTLE, PLASTIC (72789-196-30) September 15, 2022
72789-196-90 72789-196 PD-Rx Pharmaceuticals, Inc. 90 TABLET in 1 BOTTLE, PLASTIC (72789-196-90) July 6, 2021
68788-7449-1 68788-7449 Preferred Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (68788-7449-1) December 27, 2019
68788-7449-3 68788-7449 Preferred Pharmaceuticals, Inc. 30 TABLET in 1 BOTTLE (68788-7449-3) December 27, 2019
68788-7449-6 68788-7449 Preferred Pharmaceuticals, Inc. 60 TABLET in 1 BOTTLE (68788-7449-6) December 27, 2019
68788-7449-9 68788-7449 Preferred Pharmaceuticals, Inc. 90 TABLET in 1 BOTTLE (68788-7449-9) December 27, 2019
71205-531-10 71205-531 Proficient Rx LP 10 TABLET in 1 BOTTLE (71205-531-10) March 11, 2024
71205-531-15 71205-531 Proficient Rx LP 15 TABLET in 1 BOTTLE (71205-531-15) March 11, 2024
71205-531-20 71205-531 Proficient Rx LP 20 TABLET in 1 BOTTLE (71205-531-20) March 11, 2024
71205-531-30 71205-531 Proficient Rx LP 30 TABLET in 1 BOTTLE (71205-531-30) February 3, 2021
71205-531-60 71205-531 Proficient Rx LP 60 TABLET in 1 BOTTLE (71205-531-60) February 3, 2021
71205-531-90 71205-531 Proficient Rx LP 90 TABLET in 1 BOTTLE (71205-531-90) February 3, 2021
11822-7652-4 11822-7652 Rite Aid 24 TABLET in 1 BLISTER PACK (11822-7652-4) October 25, 2024
11822-7660-3 11822-7660 Rite Aid 30 TABLET in 1 BOTTLE (11822-7660-3) October 1, 2024
11822-7660-7 11822-7660 Rite Aid 15 TABLET in 1 BLISTER PACK (11822-7660-7) October 1, 2024
11822-7660-9 11822-7660 Rite Aid 90 TABLET in 1 BOTTLE (11822-7660-9) October 1, 2024
11822-7661-5 11822-7661 Rite Aid 766 TABLET in 1 BOTTLE (11822-7661-5) October 25, 2024
11822-7663-4 11822-7663 Rite Aid 70 TABLET in 1 BOTTLE (11822-7663-4) October 25, 2024
11822-7664-5 11822-7664 Rite Aid 45 TABLET in 1 BOTTLE (11822-7664-5) October 1, 2024
21130-769-03 21130-769 Safeway, Inc 30 TABLET in 1 BOTTLE (21130-769-03) November 6, 2023
21130-769-07 21130-769 Safeway, Inc 15 TABLET in 1 BLISTER PACK (21130-769-07) November 6, 2023
70677-1256-1 70677-1256 Strategic Sourcing Services 1 BOTTLE in 1 CARTON (70677-1256-1) / 30 TABLET in 1 BOTTLE May 1, 2025
70677-1256-2 70677-1256 Strategic Sourcing Services 1 BOTTLE in 1 CARTON (70677-1256-2) / 500 TABLET in 1 BOTTLE May 1, 2025
11673-767-03 11673-767 TARGET CORPORATION 30 TABLET in 1 BOTTLE (11673-767-03) March 1, 2024
11673-767-07 11673-767 TARGET CORPORATION 15 TABLET in 1 BLISTER PACK (11673-767-07) March 1, 2024
11673-767-15 11673-767 TARGET CORPORATION 150 TABLET in 1 BOTTLE (11673-767-15) March 1, 2024
11673-767-34 11673-767 TARGET CORPORATION 70 TABLET in 1 BOTTLE (11673-767-34) March 1, 2024
0363-6231-24 0363-6231 Walgreens 24 TABLET in 1 BOTTLE (0363-6231-24) July 23, 2024
0363-9760-03 0363-9760 Walgreens 30 TABLET in 1 BOTTLE (0363-9760-03) February 28, 2024
0363-9760-07 0363-9760 Walgreens 15 TABLET in 1 BLISTER PACK (0363-9760-07) February 28, 2024
0363-9760-14 0363-9760 Walgreens 5 TABLET in 1 BLISTER PACK (0363-9760-14) February 28, 2024
0363-9760-18 0363-9760 Walgreens 180 TABLET in 1 BOTTLE (0363-9760-18) February 28, 2024
0363-9760-34 0363-9760 Walgreens 70 TABLET in 1 BOTTLE (0363-9760-34) February 28, 2024
0363-9765-24 0363-9765 Walgreens 24 TABLET in 1 BLISTER PACK (0363-9765-24) February 27, 2024
79903-358-30 79903-358 Walmart Inc. 300 TABLET in 1 BOTTLE (79903-358-30) May 19, 2025
79903-358-45 79903-358 Walmart Inc. 1 BOTTLE in 1 CARTON (79903-358-45) / 45 TABLET in 1 BOTTLE May 19, 2025
79903-358-90 79903-358 Walmart Inc. 2 BOTTLE in 1 CARTON (79903-358-90) / 90 TABLET in 1 BOTTLE May 19, 2025
73581-009-01 73581-009 YYBA Corp 10 TABLET in 1 BOTTLE (73581-009-01) January 1, 2026
73581-009-04 73581-009 YYBA Corp 40 TABLET in 1 BOTTLE (73581-009-04) January 1, 2026
73581-009-10 73581-009 YYBA Corp 100 TABLET in 1 BOTTLE (73581-009-10) January 1, 2026
73581-009-20 73581-009 YYBA Corp 200 TABLET in 1 BOTTLE (73581-009-20) January 1, 2026
73581-010-01 73581-010 YYBA Corp 10 TABLET in 1 BOTTLE (73581-010-01) January 1, 2026
73581-010-06 73581-010 YYBA Corp 60 TABLET in 1 BOTTLE (73581-010-06) January 1, 2026
73581-010-10 73581-010 YYBA Corp 100 TABLET in 1 BOTTLE (73581-010-10) January 1, 2026
73581-010-20 73581-010 YYBA Corp 200 TABLET in 1 BOTTLE (73581-010-20) January 1, 2026
50090-4070 50090-4070 A-S Medication Solutions — August 19, 2016
50090-4267 50090-4267 A-S Medication Solutions — August 19, 2016
50090-6965 50090-6965 A-S Medication Solutions — February 18, 2019
71399-8042 71399-8042 Akron Pharma Inc. — September 9, 2020
71335-1217 71335-1217 Bryant Ranch Prepack — August 19, 2016
51316-767 51316-767 CVS — March 27, 2024
51316-768 51316-768 CVS — January 1, 2024
69230-301 69230-301 Camber Consumer Care — August 19, 2016
69230-300 69230-300 Camber Consumer Care Inc — August 19, 2016
70010-183 70010-183 GRANULES PHARMACEUTICALS INC. — April 25, 2023
79481-7660 79481-7660 Meijer — September 9, 2024
79481-6230 79481-6230 Meijer, Inc. — July 1, 2024
16714-899 16714-899 NorthStar RxLLC — February 18, 2019
51655-854 51655-854 Northwind Health Company, LLC — February 7, 2023
72789-196 72789-196 PD-Rx Pharmaceuticals, Inc. — February 18, 2019
68788-7449 68788-7449 Preferred Pharmaceuticals, Inc. — August 19, 2016
71205-531 71205-531 Proficient Rx LP — August 19, 2016
11822-7652 11822-7652 Rite Aid — October 25, 2024
11822-7660 11822-7660 Rite Aid — October 1, 2024
11822-7661 11822-7661 Rite Aid — October 25, 2024
11822-7663 11822-7663 Rite Aid — October 25, 2024
11822-7664 11822-7664 Rite Aid — October 1, 2024
21130-769 21130-769 Safeway, Inc — November 6, 2023
70677-1256 70677-1256 Strategic Sourcing Services — May 1, 2025
11673-767 11673-767 TARGET CORPORATION — March 1, 2024
0363-6231 0363-6231 Walgreens — July 23, 2024
0363-9760 0363-9760 Walgreens — February 28, 2024
0363-9765 0363-9765 Walgreens — February 27, 2024
79903-358 79903-358 Walmart Inc. — May 19, 2025
73581-009 73581-009 YYBA Corp — August 19, 2016
73581-010 73581-010 YYBA Corp — January 1, 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.