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 7 of 52 · 1,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
unii: Q40Q9N063P
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECVS Pharmacy, Inc.b45c95f2-91c9-55b5-e053-2995a90a75b72026-05-04WarningsExact identifier
unii: 64O047KTOA
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECVS Pharmacy, Inc.b955c7ed-29da-959f-e053-2a95a90a03d42026-05-04WarningsExact identifier
unii: 64O047KTOA
CetirizineCETIRIZINE HYDROCHLORIDEMajor Pharmaceuticals71db132d-dca4-47ef-8560-c68ad22589332026-05-04WarningsExact identifier
unii: 64O047KTOA
childrens dye free allergy reliefCETIRIZINE HCLKroger Company2ecf7dac-97fd-49b3-87ce-9b473834bd7e2026-05-01WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESafecor Health, LLC734118ec-bf9a-4e58-b728-50b6c832b2702026-05-01WarningsExact identifier
unii: 64O047KTOA
childrens dye free allergy reliefCETIRIZINE HCLKroger Companyc6660c5c-1504-4a92-95e8-cc3a018e813b2026-04-30WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
ZyrtecCETIRIZINE HYDROCHLORIDEKenvue Brands LLCdc613bd5-70fd-1d9b-e053-2995a90a41cd2026-04-27WarningsExact identifier
unii: 64O047KTOA
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: PDC6A3C0OX
Allergy ReliefCETIRIZINE TABLETSDISCOUNT DRUG MART, INC4b9576dc-d7f9-dc10-e063-6294a90a233e2026-04-23WarningsExact identifier
unii: 64O047KTOA
Childrens ZyrtecCETIRIZINE HYDROCHLORIDEKenvue Brands LLC0fe77356-d945-46a0-882e-b3bbab7845562026-04-22WarningsExact identifier
unii: 64O047KTOA
All Day AllergyCETIRIZINE HYDROCHLORIDEHyVee Inc8889af37-8345-4358-994d-7d8b847f48742026-04-22WarningsExact identifier
unii: 64O047KTOA
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
unii: PDC6A3C0OX
Cetirizine HClCETIRIZINE HCLMeijer Distribution Inc3143de16-2006-ec2e-e063-6294a90a1f672026-04-20WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINE HCLWALGREEN COMPANY4a181a38-ac94-8d00-e063-6394a90a6bf62026-04-20WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINE HCLBionpharma Inc.4fe8f764-a8e2-a432-e063-6294a90a33b02026-04-20WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINE HCLTARGET Corporation363845a9-c379-16a7-e063-6394a90a011a2026-04-20WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINE HCLKROGER COMPANY33f181f8-6e0d-b89b-e063-6394a90aeae72026-04-20WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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