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 33 of 51 · 1,016 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: Q40Q9N063P
good neighbor pharmacy all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEAmerisource Bergena7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b2025-01-03WarningsExact identifier
unii: 64O047KTOA
Good Neighbor Pharmacy Childrens All Day AllergyCETIRIZINE HCLAmerisource Bergenc6951587-fe03-4bc8-8f0c-0687d49f71592025-01-03WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDERITE AID1bf7c028-1648-4211-8847-84cce833a0f12025-01-02WarningsExact identifier
unii: 64O047KTOA
Prevention Oncology Mouth RinseGLYCERINPrevention Health Sciences, Inc.1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c2025-01-01WarningsExact identifier
unii: PDC6A3C0OX
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsExact identifier
unii: 6DC9Q167V3
CLENZIDERM THERAPEUTIC MOISTURIZERGLYCERINObagi Cosmeceuticals LLCd60e22e3-831e-4787-a82c-e7763c2875532025-01-01WarningsExact identifier
unii: PDC6A3C0OX
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: 6DC9Q167V3
CABINET Allergy ReliefCETIRIZINE HYDROCHLORIDESpirit Pharmaceutical LLCe49c3c91-aab8-478e-97fa-04ed061800212024-12-30WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HYDROCHLORIDESpirit Pharmaceutical LLC507df969-804c-4e95-bb42-c1224fce2b282024-12-30WarningsExact identifier
unii: 64O047KTOA
Acetic AcidACETIC ACIDTruPharma, LLC0c5ebd59-0e98-4ea1-b279-9202a19f6dbf2024-12-27Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Tucks Triple Relief HemorrhoidalWHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEBlistex Inc.bf892e90-2d9b-4fa0-8ee4-8a2736be6c302024-12-24WarningsExact identifier
unii: PDC6A3C0OX
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.4e15f6ca-a40c-485f-be3f-07c2ed7cb4982024-12-23WarningsExact identifier
unii: PDC6A3C0OX
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
unii: PDC6A3C0OX
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 6DC9Q167V3
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Rite Aid childrens allergy reliefCETIRIZINE HYDROCHLORIDERite Aid Corporationedbefbee-26b6-46bc-abcc-f7b2817705e52024-12-19WarningsExact identifier
application number: ANDA201546
rxcui: 1014673
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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