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Active ingredient

Cetirizine

409 finished FDA listings contain Cetirizine as their only active ingredient; 31 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
CETIRIZINE, CETIRIZINE HYDROCHLORIDE
Dosage forms
Capsule, Capsule, Liquid Filled, For Solution, Injection, Solution, Syrup, Tablet, Tablet, Chewable, Tablet, Coated, Tablet, Film Coated, Tablet, Orally Disintegrating
Routes
Intravenous, Ophthalmic, Oral
Manufacturers / labelers
182
Strengths listed
1 mg/ml · 10 mg/1 · 10 mg/ml · 2.4 mg/ml · 2.5 mg/1 · 25 mg/1 · 5 mg/1 · 5 mg/5ml
Brand names in FDA listings (first 80 of 103, A–Z)
24 Hour Allergy, All Day Allergy, All Day Allergy Relief, Allergy, Allergy Relief, Allergy Relief All Day, Allergy Relief Childrens, Allergy Relief Indoor And Outdoor Allergies, Amazon Basic Care All Day Allergy Relief, Amazon Basics All Day Allergy Relief, Basic Care All Day Allergy, Basic Care Childrens All Day Allergy, Berkley And Jensen All Day Allergy, Betr Remedies All Day Allergy Relief, Cabinet All Day Allergy Relief, Cabinet Allergy Relief, Cabinet Allergy Relief Refill Cetirizine Hci, Careall Allergy Relief, Careone Allergy Relief, Careone Childrens Allergy Relief, Cetirizine, Cetirizine Hcl, Cetirizine Hydrochloride, Cetirizine Hydrochloride - Hives, Cetirizine Hydrochloride (Allergy), Cetirizine Hydrochloride (Hives Relief), Cetirizine Hydrochloride 10 Mg, Cetirizine Hydrochloride Hives Relief, Cetirizine Hydrochloride Tablets, 10 Mg, Cetirizine Hydrochloride Tablets, 10 Mg (Oval Shape), Cetirizine Hydrochloride Tablets, 5 Mg, Cetirizine Hydrochloride Tablets,10 Mg, Cetirza, Cetrizine Hydrochloride, Childrens 24 Hour Allergy, Childrens All Day Allergy, Childrens Allergy, Childrens Allergy Relief, Childrens Cetirizine Hydrochloride, Childrens Cetirizine Hydrochloride Allergy, Childrens Cetirizine Hydrochloride Hives Relief, Childrens Cetirizine Hydrochloride Sugar Free Grape, Childrens Cetirzine, Childrens Dye Free Allergy Relief, Childrens Zyrtec, Childrens Zyrtec Allergy, Crcle Cetirizine Hydrochloride, Curist Allergy Relief, Cvs Cetirizine Hydrochloride, Dg Health All Day Allergy, Dg Health Childrens All Day Allergy, Dr Simi Cetirizine Hydrochloride 10 Mg, Dye Free Childrens Cetirizine Hydrocholride, Equaline All Day Allergy, Equaline Childrens All Day Allergy, Equate Allergy Relief, Equate Childrens Allergy Relief, Exchange Select All Day Allergy, Foster And Thrive Childrens Allergy Relief, Good Neighbor Pharmacy All Day Allergy, Good Neighbor Pharmacy Childrens All Day Allergy, Good Remedies All Day Allergy Relief, Good Sense All Day Allergy, Good Sense Childrens All Day Allergy, Goodmeds All Day Allergy Relief Cetirizine Hcl, Goodnow Allergy Relief, Heb Allergy Relief, Hives Relief, Indoor And Outdoor Allergy Relief, Kirkland Signature Aller Tec Allergy, Kirkland Signature Childrens Aller Tec, Leader All Day Allergy, Leader Childrens All Day Allergy, Medline, Medline Industries, Members Mark Allergy Relief, Members Mark Childrens Cetirizine, Pentrexcilina Day Time, Premier Value Childrens Cetirizine, Quality Choice Cetirizine Hydrochloride

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 20610

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 019835KENVUE BRANDS1995-12-089
NDA 021621KENVUE BRANDS2004-03-165
NDA 022155KENVUE BRANDS2007-11-163
ANDA 077946PLD ACQUISITIONS2007-12-272
ANDA 077498SUN PHARM INDS LTD2007-12-2714
ANDA 076047CONTRACT PHARMACAL2007-12-275
ANDA 078336PERRIGO R AND D2007-12-2745
ANDA 076677MYLAN2007-12-275
ANDA 078427GLENMARK PHARMS2007-12-283
ANDA 078343DR REDDYS LABS LTD2008-01-1512
ANDA 078692SANDOZ2008-02-142
ANDA 090254PERRIGO R AND D2008-04-092
ANDA 090182TARO2008-04-2212
ANDA 078398PADAGIS US2008-06-172
ANDA 078412PHARM ASSOC2008-06-181
ANDA 076601TARO2008-06-204
ANDA 078862ORBION PHARMS2009-02-193
ANDA 078870APOZEAL PHARMS2009-04-272
NDA 022429BIONPHARMA2009-07-2323
ANDA 077829UNIQUE2009-08-2626
ANDA 090765AMNEAL PHARMS2009-10-072
ANDA 090191BAJAJ2009-11-123
ANDA 078780AMNEAL PHARMS NY2010-01-214
ANDA 090750AUROBINDO PHARMA2010-02-026
ANDA 078933PHARMAZONE2010-06-1510
NDA 022578KENVUE BRANDS2010-09-032
ANDA 201546TARO2011-05-208
ANDA 091327BAJAJ2011-10-174
ANDA 078876CHARTWELL MOLECULAR2012-05-113
ANDA 204226PERRIGO R AND D2013-09-0945
ANDA 090760AUROBINDO PHARMA LTD2015-08-0522
ANDA 207235APOTEX2016-08-127
ANDA 205291ONESOURCE2017-07-213
ANDA 209274GRANULES2017-12-2256
ANDA 209107AUROBINDO PHARMA LTD2018-07-208
ANDA 210622HETERO LABS LTD III2019-03-133
ANDA 212266QUAGEN2019-05-163
NDA 211415ESTEVE2019-10-042
ANDA 213557AUROBINDO PHARMA LTD2020-09-1111
ANDA 213105CATALENT2020-09-2118

Showing 40 of 48 applications.

Official labeling on DailyMed

Showing the 12 most recent of 392 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.