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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.

ApplicationSponsorOriginal approvalListings
NDA 019658BAYER HEALTHCARE LLC1993-04-1211
NDA 020641BAYER HEALTHCARE LLC1996-10-102
NDA 020704BAYER HEALTHCARE LLC1996-12-232
NDA 021375FDN CONSUMER2002-12-192
ANDA 075209PLD ACQUISITIONS LLC2003-01-2123
ANDA 076134SUN PHARM INDS LTD2003-08-1828
ANDA 076154MYLAN2003-08-203
ANDA 076011PERRIGO PHARMA INTL2003-09-2915
ANDA 076301PERRIGO2004-06-2542
ANDA 076805TARO2004-08-2014
ANDA 075728PERRIGO2004-08-2022
ANDA 076471APOTEX2006-02-143
ANDA 077421LANNETT CO INC2006-06-295
NDA 021891BAYER HEALTHCARE LLC2006-08-234
NDA 021993BAYER HEALTHCARE LLC2006-12-121
ANDA 077153SUN PHARM INDS LTD2007-04-111
ANDA 201865TARO2015-07-315
ANDA 206214MARKSANS PHARMA2016-09-2310
ANDA 208477AUROBINDO PHARMA LTD2018-04-1115
ANDA 210088SUN PHARM2018-04-1637
ANDA 208314AUROBINDO PHARMA LTD2018-04-1621
ANDA 208931AUROBINDO PHARMA LTD2018-06-294
ANDA 202538BIONPHARMA2018-12-216
ANDA 210033PERRIGO PHARMA INTL2019-06-1213
ANDA 210722GRANULES2019-12-2343
ANDA 214280RUBICON RESEARCH2020-09-101
ANDA 212795INSTAPILL2020-09-186
ANDA 213294INSTAPILL2020-10-309
ANDA 214684UNIQUE PHARM2021-01-0712
ANDA 210409HETERO LABS LTD III2021-05-071
ANDA 211900AUROBINDO PHARMA2023-03-241
ANDA 211718HETERO LABS LTD V2023-07-286
ANDA 219223PHARMAZONE2024-11-212

Official labeling on DailyMed

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.