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Fexofenadine HCL
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| 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| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | August 19, 2016 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUSE(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
openFDA Drug LabelingPurpose .Antihistamine
Dosage and Administration
openFDA Drug LabelingDIRECTIONS 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
Warnings
openFDA Drug LabelingSevere 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
openFDA Drug LabelingDo 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingACTIVE INGREDIENT(S), in each tablet Fexofenadine hydrochloride USP, 180 mg
How Supplied / Storage and Handling
openFDA Drug LabelingHOW 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 FAERSAttributed 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| 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
| 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.