FDA.reportPublic FDA data

NDC 51672-2106-01 - Cetirizine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-2106
Requested NDC
51672-2106-01
Package NDCs from labels
51672-2106-8, 51672-2106-1, 51672-2106-4, 51672-2106-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.
Effective date
2026-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Children's Cetirizine Hydrochloride Oral SolutionSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.2026-07-14HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2106-1Cetirizine Hydrochloride1 in 1 CARTONSOLUTION16
51672-2106-1Cetirizine Hydrochloride240 mL in 1 BOTTLESOLUTION2406
51672-2106-4Cetirizine Hydrochloride1 in 1 CARTONSOLUTION16
51672-2106-4Cetirizine Hydrochloride60 mL in 1 BOTTLESOLUTION606
51672-2106-8Cetirizine Hydrochloride1 in 1 CARTONSOLUTION16
51672-2106-8Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2106CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 6 package rows20241211_67207357-5f8a-4424-9901-d2717a43cf1b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
CetirizineACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
acetic acidINACTIVE INGREDIENTQ40Q9N063PCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4
waterINACTIVE INGREDIENT059QF0KO0RCETIRIZINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]4

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 45 of 51 · 1,016 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: PDC6A3C0OX
unii: 059QF0KO0R
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
PancreaparSYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUMEnergique, Inc.99a4560e-f124-4569-a2f1-78ce5995f8e02023-08-24WarningsExact identifier
unii: Q40Q9N063P
Acetic AcidACETIC ACIDB. Braun Medical Inc.dd45cee3-9938-4dad-a5e1-1dd4baea85a92023-08-23Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 6DC9Q167V3
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 6DC9Q167V3
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsf4da9adf-840d-4526-86a6-6666183fd1072023-07-06WarningsExact identifier
unii: 64O047KTOA
Aceticum acidumACETIC ACIDBoiron69214a87-0b8c-702d-e053-2a91aa0a34162023-07-03Exact identifier
unii: Q40Q9N063P
Leader Allergy Relief DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader3152060c-f613-49db-91d4-356d2070c4662023-06-15WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEWALGREEN CO.c0165b0e-d5e9-a028-e053-2a95a90ab4312023-05-25WarningsExact identifier
unii: 64O047KTOA
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Allergy ReliefCETIRIZINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIadcd0e8e-cca7-e1bb-e053-2995a90a83be2023-05-17WarningsExact identifier
unii: 64O047KTOA
betr remedies all day allergy reliefCETIRIZINE HYDROCHLORIDELive Betr LLC4a017852-db01-4085-8947-d92a19ec4e5c2023-05-10WarningsExact identifier
unii: 64O047KTOA
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Kirkland Signature Childrens Aller TecCETIRIZINE HCLCostco Wholesale Companyeb14a311-7918-4c4b-ae05-7606cfb8a4af2023-05-04WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.