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 48 of 51 · 1,016 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDETIME CAP LABORATORIES, INC.dfbddafb-9455-5805-e053-2a95a90ad0d92022-05-24WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINE HCLAMERISOURCE BERGEN75f2649d-005e-4f16-a7c3-ae966f3a7a002022-05-19WarningsExact identifier
unii: 64O047KTOA
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Allergy ReliefCETIRIZINE HCLWinCo Foods, LLC39a7d993-805d-4fe8-bc21-3b08e8f78b622022-05-11WarningsExact identifier
unii: 64O047KTOA
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEProficient Rx LP198ca875-bb8a-49d5-8809-7121ba1193812022-04-01WarningsExact identifier
unii: 64O047KTOA
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp Inc6baa66e7-93df-43d9-a301-5d9c14274c992022-04-01WarningsExact identifier
unii: 64O047KTOA
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
allergy reliefCETIRIZINE HYDROCHLORIDEPublix Super Markets Inc268170c9-b6a7-4851-b7d3-33dd1d733e392022-03-07WarningsExact identifier
unii: 64O047KTOA
DG Health Childrens All Day AllergyCETIRIZINE HCLDolgencorp, LLC9cdccfec-4373-452b-a574-f40b2a97f3702022-02-03WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
basic care all day allergyCETIRIZINE HYDROCHLORIDEAmazon.com Services LLCc3e987c5-7ca1-4514-aa0a-6668ff2937c52022-01-04WarningsExact identifier
unii: 64O047KTOA
OHM Fatigue ReliefACETICUM AC, ADRENAL GLAND, ARNICA, BENZOICUM AC, FERRUM PHOS, FLUORICUM AC, GINSENG, KALI CARB, KALI LOD, KALI MUR, KALI PHOS, LACTICUM AC, PHOSPHORICUM AC, PICRICUM AC.OHM PHARMA INC.419c6315-37de-46b4-8bef-abbeace265b62021-12-29WarningsExact identifier
unii: Q40Q9N063P
Weight ControlACETICUM AC, ANACARD OR, BARYTA IOD, CALC CARB, CAPSICUM, FUCUS, GRAPHITES,, NAT SULPHURICUM, PHYTOLACCA, STANNUM MET, THYROIDINUM, ZINC MET.OHM PHARMA INC.32b7b539-ee54-4c80-a6d9-c159600927f52021-12-29WarningsExact identifier
unii: Q40Q9N063P
Healthy Start Weight and Appetite SupportACETICUM ACIDUM, ANACARDIUM ORIENTALE, BARYTA IODATA, CALCAREA CARBONICA, CAPSICUM ANNUM, FUCUS VESICULOSUS, GRAPHITES, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, STANNUM METALLICUM, THYRDOIDINUM, ZINUM METALLICUMWELL BODY CONCEPTS LLCd11b070a-2b55-4b79-933b-c628a38f584e2021-12-29WarningsExact identifier
unii: Q40Q9N063P
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Allergy ReliefCETIRIZINE HYDROCHLORIDEMagno-Humphries, Inc.f0a3e654-5fec-4f98-84da-4c30500633b42021-10-28WarningsExact identifier
unii: 64O047KTOA
Basic Care Childrens All Day AllergyCETIRIZINE HCLAmazon.com Services LLC6cf67d32-5e61-42f4-9123-ab8debdfec4f2021-08-23WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
CareOne Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerican Sales Company833e8904-d37d-4478-af7c-8287f2d079a72021-08-16WarningsExact identifier
unii: 64O047KTOA
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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