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 2 of 64 · 1,261 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBetter Living Brands, LLCf7e16d96-4f23-cbca-e053-6394a90aef4e2026-08-24WarningsExact identifier
unii: 64O047KTOA
GOOD REMEDIES All Day Allergy ReliefCETIRIZINE HYDROCHLORIDEStrive Pharmaceuticals Inc.44410d76-5940-4611-be45-579e2db8a65d2026-08-24WarningsExact identifier
unii: 64O047KTOA
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4913192a-7364-3f19-e054-00144ff8d46c2026-08-20WarningsExact identifier
unii: 64O047KTOA
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Zyrtec Allergy Cetirizine HClCETIRIZINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc59cef432-41ac-768c-e063-6294a90a38fa2026-08-19WarningsExact identifier
unii: 64O047KTOA
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company678dcc09-55da-4d9d-a39a-c450c61c387b2026-08-18WarningsExact identifier
unii: 64O047KTOA
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
AMAZON BASICS ALL DAY ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEAmazon.com Services LLC52163488-0b56-529d-e063-6294a90afc622026-08-17WarningsExact identifier
unii: 64O047KTOA
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
allergy relief childrensCETIRIZINE HCLCVS Pharmacy1a20acb5-207f-4499-a4c3-8733454555382026-08-13WarningsExact identifier
unii: 64O047KTOA
Childrens Allergy ReliefCETIRIZINE HCLCVS Pharmacy0210f9e5-c35b-4cfa-92d1-48555e99f1f32026-08-13WarningsExact identifier
unii: 64O047KTOA
CHILDRENS ALL DAY ALLERGYCETIRIZINE HCLAmazon.com Services LLC29bac87e-8559-47be-838d-c00e57f9f7ba2026-08-12WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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