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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 019835 | KENVUE BRANDS | 1995-12-08 | 9 |
| NDA 021621 | KENVUE BRANDS | 2004-03-16 | 5 |
| NDA 022155 | KENVUE BRANDS | 2007-11-16 | 3 |
| ANDA 077946 | PLD ACQUISITIONS | 2007-12-27 | 2 |
| ANDA 077498 | SUN PHARM INDS LTD | 2007-12-27 | 14 |
| ANDA 076047 | CONTRACT PHARMACAL | 2007-12-27 | 5 |
| ANDA 078336 | PERRIGO R AND D | 2007-12-27 | 45 |
| ANDA 076677 | MYLAN | 2007-12-27 | 5 |
| ANDA 078427 | GLENMARK PHARMS | 2007-12-28 | 3 |
| ANDA 078343 | DR REDDYS LABS LTD | 2008-01-15 | 12 |
| ANDA 078692 | SANDOZ | 2008-02-14 | 2 |
| ANDA 090254 | PERRIGO R AND D | 2008-04-09 | 2 |
| ANDA 090182 | TARO | 2008-04-22 | 12 |
| ANDA 078398 | PADAGIS US | 2008-06-17 | 2 |
| ANDA 078412 | PHARM ASSOC | 2008-06-18 | 1 |
| ANDA 076601 | TARO | 2008-06-20 | 4 |
| ANDA 078862 | ORBION PHARMS | 2009-02-19 | 3 |
| ANDA 078870 | APOZEAL PHARMS | 2009-04-27 | 2 |
| NDA 022429 | BIONPHARMA | 2009-07-23 | 23 |
| ANDA 077829 | UNIQUE | 2009-08-26 | 26 |
| ANDA 090765 | AMNEAL PHARMS | 2009-10-07 | 2 |
| ANDA 090191 | BAJAJ | 2009-11-12 | 3 |
| ANDA 078780 | AMNEAL PHARMS NY | 2010-01-21 | 4 |
| ANDA 090750 | AUROBINDO PHARMA | 2010-02-02 | 6 |
| ANDA 078933 | PHARMAZONE | 2010-06-15 | 10 |
| NDA 022578 | KENVUE BRANDS | 2010-09-03 | 2 |
| ANDA 201546 | TARO | 2011-05-20 | 8 |
| ANDA 091327 | BAJAJ | 2011-10-17 | 4 |
| ANDA 078876 | CHARTWELL MOLECULAR | 2012-05-11 | 3 |
| ANDA 204226 | PERRIGO R AND D | 2013-09-09 | 45 |
| ANDA 090760 | AUROBINDO PHARMA LTD | 2015-08-05 | 22 |
| ANDA 207235 | APOTEX | 2016-08-12 | 7 |
| ANDA 205291 | ONESOURCE | 2017-07-21 | 3 |
| ANDA 209274 | GRANULES | 2017-12-22 | 56 |
| ANDA 209107 | AUROBINDO PHARMA LTD | 2018-07-20 | 8 |
| ANDA 210622 | HETERO LABS LTD III | 2019-03-13 | 3 |
| ANDA 212266 | QUAGEN | 2019-05-16 | 3 |
| NDA 211415 | ESTEVE | 2019-10-04 | 2 |
| ANDA 213557 | AUROBINDO PHARMA LTD | 2020-09-11 | 11 |
| ANDA 213105 | CATALENT | 2020-09-21 | 18 |
Showing 40 of 48 applications.
Official labeling on DailyMed
- ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [LIDL US LLC] · version 3 · 2026-09-10
- ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION] · version 5 · 2026-09-07
- ALLERGY RELIEF (CETIRIZINE HCL) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC] · version 6 · 2026-09-07
- CETIRIZINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [AUROHEALTH LLC] · version 6 · 2026-09-03
- CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [AUROHEALTH LLC] · version 5 · 2026-09-03
- CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HCL) SOLUTION [ATLANTIC BIOLOGICALS CORP.] · version 4 · 2026-09-02
- ZYRTEC ALLERGY CETIRIZINE HCL (CETIRIZINE HYDROCHLORIDE) CAPSULE [JONES HEALTHCARE GROUP - PACKAGING SERVICES, INC] · version 1 · 2026-09-02
- QUZYTTIR (CETIRIZINE HYDROCHLORIDE) INJECTION [ESTEVE PHARMACEUTICALS, S.A.] · version 4 · 2026-09-02
- CETIRIZINE HCL (CETIRIZINE) TABLET CETIRIZINE HCL (CETIRIZINE) KIT [GLENMARK THERAPEUTICS INC., USA] · version 7 · 2026-08-31
- CETIRIZINE HYDROCHLORIDE SOLUTION [BAJAJ MEDICAL, LLC] · version 4 · 2026-08-31
- GOOD REMEDIES ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [STRIVE PHARMACEUTICALS INC.] · version 1 · 2026-08-31
- AMAZON BASICS ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) CAPSULE [AMAZON.COM SERVICES LLC] · version 2 · 2026-08-28
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.