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 1 of 64 · 1,261 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC36b6d0e4-8da5-9df5-e063-6294a90af3262026-10-01WarningsExact identifier
unii: 64O047KTOA
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy ReliefCETIRIZINE HYDROCHLORIDELIDL US LLCe5fd935d-5b60-7270-e053-2995a90a71412026-09-09WarningsExact identifier
unii: 64O047KTOA
all day allergyCETIRIZINE HYDROCHLORIDERite Aid Corporationbcbb9f5a-10b6-4a5e-a237-d29693d781032026-09-04WarningsExact identifier
unii: 64O047KTOA
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
childrens cetirizine hydrochlorideCETIRIZINE HCLATLANTIC BIOLOGICALS CORP.cb47e536-8eed-4a32-b9c2-e8535fb938862026-09-01WarningsExact identifier
unii: 64O047KTOA
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCfb850a4c-7ac1-4993-b6ea-5c8d42e177032026-08-26WarningsExact identifier
unii: 64O047KTOA
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC26f2c3c1-a2f2-474a-950a-8cfe07f289fa2026-08-25WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLC17e93c22-1ff7-4af9-bd5a-448836aec65f2026-08-25WarningsExact identifier
unii: 64O047KTOA
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLCcd895177-3c25-4a1b-81a0-b85f4877787a2026-08-25WarningsExact identifier
unii: 64O047KTOA
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEStrides Pharma, Inc.29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba2026-08-24WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINE HCLCVS Pharmacy52192baa-3ce4-b2c3-e063-6294a90a28fc2026-08-24WarningsExact identifier
unii: 64O047KTOA
Zyrtec Allergy Cetirizine HClCETIRIZINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc59cf7672-fdde-ddbd-e063-6394a90a223b2026-08-24WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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