FDA.reportPublic FDA data

NDC 0781-5283-06 - 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
0781-5283
Requested NDC
0781-5283-06
Package NDCs from labels
0781-5283-06, 0781-5283-64
Manufacturer
Sandoz Inc
Effective date
2025-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cetirizine Hydrochloride - Sandoz IncSandoz Inc2025-06-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-5283-06Cetirizine Hydrochloride1 in 1 BLISTER PACKTABLET, CHEWABLE17
0781-5283-64Cetirizine Hydrochloride30 in 1 CARTONTABLET, CHEWABLE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5283CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]7Current NDC, Legacy NDC, 2 package rows20250201_817d07cf-5e31-421f-9e95-943bae01f5b0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5283-06EA - Each0781-52839597b375-16fa-45e7-bd32-2b8a665b5ed312018-11-06
0781-5283-64EA - Each0781-5283769a8519-0fc0-46fb-9d34-27d6048503bb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
BETADEXINACTIVE INGREDIENTJV039JZZ3ACETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]2

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 4 of 64 · 1,261 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate allergy reliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb33eb97f-5ac3-4eb7-b23a-cf550ce462872026-08-05WarningsExact identifier
unii: 64O047KTOA
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC3cf969e6-6bc9-4dae-ab6a-b24c0fc46b252026-08-03WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLC2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a2026-08-03WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.af18ca44-615e-48ef-b678-7a9ae02e0f2a2026-08-03WarningsExact identifier
unii: 64O047KTOA
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECardinal Health 107, LLC0b0190c7-acfd-4140-bcaf-9fe835ebaf492026-07-30WarningsExact identifier
unii: 64O047KTOA
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
CHILDRENS ALL DAY ALLERGYCETIRIZINE HCLAmazon.com Services LLCf9b17231-1787-4726-8e19-cf3430dd811c2026-07-29WarningsExact identifier
unii: 64O047KTOA
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp Incb9ac489a-80ed-4077-b68e-d03df1b892a62026-07-28WarningsExact identifier
unii: 64O047KTOA
childrens allergy reliefCETIRIZINE HCLRite Aid Corporation978d8779-3c00-4b21-9cc3-f6a962194dfe2026-07-24WarningsExact identifier
unii: 64O047KTOA
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
childrens allergy reliefCETIRIZINE HCLRite Aid Corporation09474431-cf46-45da-8b20-9551ddea28a72026-07-24WarningsExact identifier
unii: 64O047KTOA
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WR1WPI7EW8
PNV-DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENTAcella Pharmaceuticals, LLC038fe2e7-dc16-485c-b5fb-746db72313472026-07-23Boxed warning, Adverse reactionsExact identifier
unii: WR1WPI7EW8
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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