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 3 of 62 · 1,230 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmapathGELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEAEnergetix Corporation3c4e2867-4d75-416b-9f3d-e6e500e46f6f2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph-Tone IIAESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.Energetix Corporationc46aa8d3-4aa5-4e07-be3d-d71abc5e24072026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph-Tone IIIADENOSINUM CYCLOPHOSPHORICUM, ARNICA, BOLDO, CALC IOD, CALENDULA, CARTILAGO SUIS, CEANOTHUS, COENZYME A, ECHINACEA, HAMAMELIS, HEPAR SULPH CALC, HYPOTHALAMUS, NADIDUM, NAJA, NAT SULPHURICUM, PHASEOLUS, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PYROGENIUM, SILICEA, SULPHUR, THUJA OCC, THYROIDINUM, VISCUMEnergetix Corporation4c9ae54c-ce7d-4276-add7-2922a8f0e3102026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Vac-ChordALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM.Energetix Corporation880ea1e6-8d4d-486e-9a8f-9d3158a996672026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Thyro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation6655b504-dfa8-46df-9d3a-b7fa4078207e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Para-ChordHOMEOPATHIC LIQUIDEnergetix Corporation9f8f646e-634a-47ff-b208-b2249d685e552026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Cetirizine HClCETIRIZINEGLENMARK THERAPEUTICS INC., USA04b08c52-5390-4cdb-a9e7-fca81fffdc732026-08-07WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US LLCbcbbcb24-2a58-917a-e053-2a95a90af9a92026-08-07WarningsExact identifier
unii: 64O047KTOA
PNV PrenatolMULTIVITAMINPureTek Corporation583f0194-0306-f31b-e063-6394a90a2a102026-08-06Warnings, Adverse reactionsExact identifier
unii: WR1WPI7EW8
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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