Active ingredient
Fexofenadine
209 finished FDA listings contain Fexofenadine as their only active ingredient; 38 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- FEXOFENADINE HYDROCHLORIDE
- Dosage forms
- Capsule, Capsule, Coated, Suspension, Tablet, Tablet, Coated, Tablet, Film Coated, Tablet, Orally Disintegrating
- Routes
- Oral
- Manufacturers / labelers
- 115
- Strengths listed
- 180 mg/1 · 30 mg/1 · 30 mg/5ml · 60 mg/1
- Brand names in FDA listings
- 12hr Allergy Relief, 24hr Allergy Relief, Allegra Allergy, Allegra Allergy 24 Hour, Allegra Allergy, Travel Basix, Allegra Hives 24hr, Allergy, Allergy Relief, Allergy Relief Non Drowsy, Basic Care Allergy, Berkley Jensen Allergy Relief, Cabinet Allergy Relief Fexofenadine, Careone Allergy Relief, Children Allergy, Childrens Allegra Allergy, Childrens Allegra Hives, Childrens Allergy, Childrens Allergy Relief, Childrens Fexofenadine Hydrochloride Allergy, Crcle Fexofenadine Hydrochloride, Curist Allergy Relief, Curist Hives Relief, Cvs Fexofenadine Hydrochloride, Dg Health Aller Ease, Dye Free Wal Fex Childrens Allergy, Equate Allergy Relief, Exchange Select Aller Ease, Fexofenadine Hcl 180 Mg, Fexofenadine Hydrochloride, Gencare Hives Relief, Gencare-Allergy Relief, Good Sense Aller Ease, Goodmeds Non Drowsy Allergy Relief, Hives Relief, Iallergy Relief, Kirkland Signature Aller Fex, Leader 24hr Allergy Relief, Non-Drowsy Allergy Relief, Nuvicare Hives Relief, Topcare Allergy Relief, Up And Up Non Drowsy Allergy Relief, Valumeds 24-Hour Allergy Relief, Valumeds Non-Drowsy Allergy Relief Fexofenadine Hcl, Wal-Fex
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 87636
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020872 | CHATTEM SANOFI | 2000-02-25 | 10 |
| ANDA 076447 | TEVA | 2005-09-01 | 1 |
| ANDA 076502 | DR REDDYS LABS LTD | 2006-04-11 | 20 |
| NDA 021909 | CHATTEM SANOFI | 2007-07-26 | 1 |
| NDA 201373 | CHATTEM SANOFI | 2011-01-24 | 3 |
| ANDA 091567 | SUN PHARM INDS | 2012-02-06 | 4 |
| ANDA 203330 | P AND L | 2014-11-18 | 9 |
| ANDA 202039 | AUROBINDO PHARMA LTD | 2014-11-19 | 4 |
| ANDA 204507 | SCIEGEN PHARMS | 2015-09-16 | 32 |
| ANDA 204097 | HETERO LABS LTD V | 2016-08-19 | 23 |
| ANDA 208123 | TARO | 2017-11-09 | 3 |
| ANDA 210137 | UNIQUE | 2018-08-13 | 10 |
| ANDA 211075 | GRANULES | 2019-10-18 | 62 |
| ANDA 212971 | L PERRIGO CO | 2020-02-24 | 23 |
| ANDA 213466 | AUROBINDO PHARMA LTD | 2023-05-23 | 2 |
| ANDA 219032 | CONTRACT PHARMACAL | 2025-02-28 | 1 |
Official labeling on DailyMed
- ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [AMAZON.COM SERVICES LLC] · version 3 · 2026-09-11
- FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE ORAL) SUSPENSION [AUROHEALTH LLC] · version 1 · 2026-09-04
- ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [BI-MART] · version 1 · 2026-08-27
- ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [SAFEWAY, INC.] · version 6 · 2026-08-19
- CHILDRENS ALLERGY (FEXOFENADINE HCL) SUSPENSION [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)] · version 5 · 2026-08-14
- CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 6 · 2026-08-13
- FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] · version 1 · 2026-08-12
- FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] · version 1 · 2026-08-12
- FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AUROHEALTH LLC] · version 1 · 2026-08-12
- DG HEALTH ALLER EASE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP INC] · version 2 · 2026-08-07
- FEXOFENADINE HYDROCHLORIDE TABLET [NUVICARE LLC] · version 2 · 2026-08-05
- FEXOFENADINE HYDROCHLORIDE TABLET [WALGREENS COMPANY] · version 5 · 2026-07-31
Showing the 12 most recent of 191 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.