Active ingredient
Loratadine
372 finished FDA listings contain Loratadine as their only active ingredient; 50 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- LORATADINE
- Dosage forms
- Capsule, Liquid Filled, Solution, Tablet, Tablet, Chewable, Tablet, Film Coated, Tablet, Orally Disintegrating
- Routes
- Oral
- Manufacturers / labelers
- 169
- Strengths listed
- 1 mg/ml · 10 mg/1 · 5 mg/1 · 5 mg/5ml
- Brand names in FDA listings (first 80 of 95, A–Z)
- 24 / 7 Life Non-Drowsy Allergy Relief, 365 Whole Foods Market Loratadine, Alavert Allergy, All Day Allergy Relief, Allergy, Allergy Relief, Allergy Relief 10 Mg, Allergy Relief 10mg, Allervarx, Amazon Basic Care Allergy Relief, Basic Care Allergy Relief, Basic Care Childrens Allergy Relief, Berkley And Jensen Allergy Relief, Berkley And Jensen Childrens Allergy Relief, Careall Allergy Relief, Careone Allergy Relief, Careone Allergy Relief 24 Hour, Careone Childrens Allergy Relief, Children Claritin Allergy, Childrens Allergy, Childrens Allergy Relief, Childrens Loratadine, Childrens Loratadine Odt, Childrens Loratadine Oral, Childrens Loratadine Sugar Free, Childrens Walitin, Claritin, Claritin Allergy, Claritin Chewable Cool Mint Flavor, Claritin Reditabs, Claritin, Bsx Non-Drowsy, 24 Hour, Claritin, Cvp Non-Drowsy, 24 Hour, Contac Allergy, Counteract Allergy, Curist Allergy Relief, Curist Childrens Allergy Relief, Cvs Loratadine, Dg Health Allergy Relief, Dg Health Childrens Allergy, Dg Health Childrens Allergy Relief, Dr Simi All Day Allergy Relief, Dye-Free Childrens Loratadine, Dye-Free Loratadine, Equaline Childrens Allergy Relief, Equate Allergy Relief, Equate Childrens Allergy, Equate Loratadine, Exchange Select Allergy Relief, First Aid Direct Allergy Relief, Foster And Thrive Allergy Relief, Foster And Thrive Childrens Allergy Relief, Gencare-Allergy Relief Loratadine Tablets, 10 Mg, Good Neighbor Pharmacy Childrens Loratadine, Good Neighbor Pharmacy Loratadine, Good Sense Allergy Relief, Good Sense Childrens Allergy Relief, Goodnow Allergy Relief, Green Guard 24 Hour Allergy Relief, Handy Solutions 24 Hour Allergy, Indoor Outdoor Allergy Relief, Kirkland Signature Allerclear, Leader Allergy Relief, Leader Childrens Allergy Relief, Lil Drug Store Claritin Non-Drowsy, 24 Hour, Loratadine, Loratadine 10 Mg, Loratadine 10mg, Loratadine Allergy Relief, Loratadine Allergy Relief 10mg, Loratadine Antihistamine, Loratadine Odt, Mckesson Loradatine, Mckesson Loratadine, Medi First Plus Allergy Relief, Medi-First Plus Allery Relief, Medique Loradamed, Members Mark Allergy Relief, Non Drowsy Allergy Relief, Non-Drowsy Allergy Relief, Non-Drowsy Allergy Relief, 24-7 Life
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 28889
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 019658 | BAYER HEALTHCARE LLC | 1993-04-12 | 11 |
| NDA 020641 | BAYER HEALTHCARE LLC | 1996-10-10 | 2 |
| NDA 020704 | BAYER HEALTHCARE LLC | 1996-12-23 | 2 |
| NDA 021375 | FDN CONSUMER | 2002-12-19 | 2 |
| ANDA 075209 | PLD ACQUISITIONS LLC | 2003-01-21 | 23 |
| ANDA 076134 | SUN PHARM INDS LTD | 2003-08-18 | 28 |
| ANDA 076154 | MYLAN | 2003-08-20 | 3 |
| ANDA 076011 | PERRIGO PHARMA INTL | 2003-09-29 | 15 |
| ANDA 076301 | PERRIGO | 2004-06-25 | 42 |
| ANDA 076805 | TARO | 2004-08-20 | 14 |
| ANDA 075728 | PERRIGO | 2004-08-20 | 22 |
| ANDA 076471 | APOTEX | 2006-02-14 | 3 |
| ANDA 077421 | LANNETT CO INC | 2006-06-29 | 5 |
| NDA 021891 | BAYER HEALTHCARE LLC | 2006-08-23 | 4 |
| NDA 021993 | BAYER HEALTHCARE LLC | 2006-12-12 | 1 |
| ANDA 077153 | SUN PHARM INDS LTD | 2007-04-11 | 1 |
| ANDA 201865 | TARO | 2015-07-31 | 5 |
| ANDA 206214 | MARKSANS PHARMA | 2016-09-23 | 10 |
| ANDA 208477 | AUROBINDO PHARMA LTD | 2018-04-11 | 15 |
| ANDA 210088 | SUN PHARM | 2018-04-16 | 37 |
| ANDA 208314 | AUROBINDO PHARMA LTD | 2018-04-16 | 21 |
| ANDA 208931 | AUROBINDO PHARMA LTD | 2018-06-29 | 4 |
| ANDA 202538 | BIONPHARMA | 2018-12-21 | 6 |
| ANDA 210033 | PERRIGO PHARMA INTL | 2019-06-12 | 13 |
| ANDA 210722 | GRANULES | 2019-12-23 | 43 |
| ANDA 214280 | RUBICON RESEARCH | 2020-09-10 | 1 |
| ANDA 212795 | INSTAPILL | 2020-09-18 | 6 |
| ANDA 213294 | INSTAPILL | 2020-10-30 | 9 |
| ANDA 214684 | UNIQUE PHARM | 2021-01-07 | 12 |
| ANDA 210409 | HETERO LABS LTD III | 2021-05-07 | 1 |
| ANDA 211900 | AUROBINDO PHARMA | 2023-03-24 | 1 |
| ANDA 211718 | HETERO LABS LTD V | 2023-07-28 | 6 |
| ANDA 219223 | PHARMAZONE | 2024-11-21 | 2 |
Official labeling on DailyMed
- LORATADINE TABLET, ORALLY DISINTEGRATING [RITE AID CORPORATION] · version 5 · 2026-09-10
- CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [RITE AID CORPORATION] · version 4 · 2026-09-10
- LORATADINE TABLET [YYBA CORP] · version 1 · 2026-09-02
- CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 5 · 2026-09-01
- AMAZON BASIC CARE ALLERGY RELIEF (LORATADINE) TABLET [AMAZON.COM SERVICES LLC] · version 4 · 2026-08-31
- CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [AMAZON.COM SERVICES LLC] · version 2 · 2026-08-28
- ALL DAY ALLERGY RELIEF (LORATADINE) TABLET [SAFEWAY, INC.] · version 8 · 2026-08-20
- LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [RUGBY LABORATORIES] · version 2 · 2026-08-18
- LORATADINE TABLET [MAJOR PHARMACEUTICALS] · version 3 · 2026-08-17
- DYE-FREE CHILDRENS LORATADINE (LORATADINE) TABLET, CHEWABLE [CVS PHARMACY, INC] · version 5 · 2026-08-07
- DYE-FREE CHILDRENS LORATADINE (LORATADINE) TABLET, CHEWABLE [CVS PHARMACY, INC] · version 7 · 2026-08-06
- DG HEALTH ALLERGY RELIEF (LORATADINE) TABLET [DOLGENCORP INC] · version 11 · 2026-07-31
Showing the 12 most recent of 353 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.