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 3 of 39 · 777 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.af18ca44-615e-48ef-b678-7a9ae02e0f2a2026-08-03WarningsExact identifier
unii: 64O047KTOA
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECardinal Health 107, LLC0b0190c7-acfd-4140-bcaf-9fe835ebaf492026-07-30WarningsExact identifier
unii: 64O047KTOA
CHILDRENS ALL DAY ALLERGYCETIRIZINE HCLAmazon.com Services LLCf9b17231-1787-4726-8e19-cf3430dd811c2026-07-29WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp Incb9ac489a-80ed-4077-b68e-d03df1b892a62026-07-28WarningsExact identifier
unii: 64O047KTOA
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
childrens allergy reliefCETIRIZINE HCLRite Aid Corporation978d8779-3c00-4b21-9cc3-f6a962194dfe2026-07-24WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
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
rxcui: 1014673
unii: 64O047KTOA
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
allergy reliefCETIRIZINE HYDROCHLORIDEH E B8649fc1e-ad56-4660-bbbb-8f1ed795697b2026-07-20WarningsExact identifier
unii: 64O047KTOA
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEKROGER COMPANYb92d959d-dd35-b2a3-e053-2995a90af3ff2026-07-15WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.67207357-5f8a-4424-9901-d2717a43cf1b2026-07-14WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Zyrtec AllergyCETIRIZINE HYDROCHLORIDESelect Consumer Group568960cf-2c8f-f1b0-e063-6294a90aebc72026-07-13WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)CETIRIZINE HYDROCHLORIDEMARKSANS PHARMA LIMITED652b0c65-a3f2-4454-9cf2-51a3389282cc2026-07-10WarningsExact identifier
unii: 64O047KTOA
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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