FDA.reportPublic FDA data

NDC 50580-730-04 - Childrens Zyrtec

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
50580-730
Requested NDC
50580-730-04
Package NDCs from labels
50580-730-05, 50580-730-06, 50580-730-01, 50580-730-17, 50580-730-18, 50580-730-19, 50580-730-04
Manufacturer
Kenvue Brands LLC
Effective date
2025-10-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Childrens Zyrtec - Kenvue Brands LLCKenvue Brands LLC2025-10-10HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50580-730-012024-02-06Children's ZYRTEC ®
50580-730-012024-02-06Children's ZYRTEC ®
50580-730-052024-02-06Children's ZYRTEC ®
50580-730-052024-02-06Children's ZYRTEC ®
50580-730-062024-02-06Children's ZYRTEC ®
50580-730-062024-02-06Children's ZYRTEC ®
50580-730-172024-02-06Children's ZYRTEC ®
50580-730-172024-02-06Children's ZYRTEC ®
50580-730-182024-02-06Children's ZYRTEC ®
50580-730-182024-02-06Children's ZYRTEC ®
50580-730-192024-02-06Children's ZYRTEC ®
50580-730-192024-02-06Children's ZYRTEC ®
50580-730-012024-01-30Children's ZYRTEC ®
50580-730-012024-01-30Children's ZYRTEC ®
50580-730-052024-01-30Children's ZYRTEC ®
50580-730-052024-01-30Children's ZYRTEC ®
50580-730-062024-01-30Children's ZYRTEC ®
50580-730-062024-01-30Children's ZYRTEC ®
50580-730-172024-01-30Children's ZYRTEC ®
50580-730-172024-01-30Children's ZYRTEC ®
50580-730-182024-01-30Children's ZYRTEC ®
50580-730-182024-01-30Children's ZYRTEC ®
50580-730-192024-01-30Children's ZYRTEC ®
50580-730-192024-01-30Children's ZYRTEC ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-730-01Childrens Zyrtec30 mL in 1 BOTTLE, PLASTICSYRUP3017
50580-730-01Childrens Zyrtec1 in 1 CARTONSYRUP117
50580-730-05Childrens Zyrtec118 mL in 1 BOTTLE, PLASTICSYRUP11817
50580-730-05Childrens Zyrtec1 in 1 CARTONSYRUP117
50580-730-06Childrens Zyrtec2 in 1 PACKAGESYRUP217
50580-730-06Childrens Zyrtec1 in 1 CARTONSYRUP117
50580-730-17Childrens Zyrtec1 in 1 TRAYSYRUP117
50580-730-17Childrens Zyrtec3 in 1 PACKAGESYRUP317
50580-730-18Childrens Zyrtec1 in 1 CARTONSYRUP117
50580-730-18Childrens Zyrtec2 in 1 PACKAGESYRUP217
50580-730-19Childrens Zyrtec240 mL in 1 BOTTLE, PLASTICSYRUP24017
50580-730-19Childrens Zyrtec1 in 1 CARTONSYRUP117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-730CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [KENVUE BRANDS LLC]16Current NDC, Legacy NDC, 12 package rows20250522_9d8e78ea-af98-4f7c-8db5-044b49582f80.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-730-01ML - Milliliter50580-730022a8af8-db63-49fd-99ba-df2675fe45be12018-08-13
50580-730-04ML - Milliliter50580-7304f38da49-8578-4902-8bd1-42dbfdecf4c912012-07-24
50580-730-05ML - Milliliter50580-730fb30f472-f871-4bae-b3c8-dea4c84974a512015-08-04
50580-730-19ML - Milliliter50580-73010959d4b-38e7-4847-ac59-30c7f8c64cb812023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOACHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
CetirizineACTIVE MOIETYYO7261ME24CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3

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 39 · 777 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacyf2f42f36-6b09-4140-e053-2a95a90af8132026-06-29WarningsExact identifier
unii: 64O047KTOA
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Allergy ReliefCETIRIZINE HCLWhole Foods Market, INC.453b20b5-72a7-ac09-e063-6394a90afc4b2026-06-22WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINE HCLPUBLIX SUPER MARKETS INC4d652305-67f3-33f3-e063-6294a90a367e2026-06-22WarningsExact identifier
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HCLWALMART INC. (see also Equate)967be504-85b1-4e9b-9b08-2b27a43fa0aa2026-06-18WarningsExact identifier
unii: 64O047KTOA
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
Equate Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb73950f4-af6f-4dc7-bce2-9ec43c45eee52026-06-12WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
MedlineCETIRIZINE HCLMedline Industries, LPa75cd557-e19b-fdd4-e053-2a95a90a80972026-06-04WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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