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 5 of 39 · 768 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEOHM LABORATORIES INC.97802669-b4bd-4807-b3c1-6c6f5a2b0c672026-06-03WarningsExact identifier
unii: 64O047KTOA
Zyrtec AllergyCETIRIZINE HYDROCHLORIDESavings Distributors LLC5490c38a-91d7-9ee1-e063-6394a90a1ea52026-06-01WarningsExact identifier
unii: 64O047KTOA
HEB Allergy ReliefCETIRIZINE HYDROCHLORIDEH E B9abdae64-4c3d-47f3-8224-fc81f7bfe5572026-05-31WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.ac22558b-5c82-4ab9-95b8-53eedea462822026-05-28WarningsExact identifier
unii: 64O047KTOA
allergy relief-DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERite Aid Corporationfdf98201-661c-4b1e-97f6-265807d90f762026-05-27WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLCc1ae7bb1-e154-4745-b01e-bc91d50d35c82026-05-25WarningsExact identifier
unii: 64O047KTOA
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Allergy ReliefCETIRIZINE HYDROCHLORIDEGrocery Outlet, Inc441d049c-8844-955e-e063-6294a90a666d2026-05-21WarningsExact identifier
unii: 64O047KTOA
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Cetrizine HydrochlorideCETIRIZINE HYDROCHLORIDEAPOZEAL PHARMACEUTICALS INC9c0549cf-4c93-45d9-9eac-3948fa45554e2026-05-18WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCa57a0dbe-0926-4b25-a5d7-b8d499d671582026-05-18WarningsExact identifier
unii: 64O047KTOA
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
Cetirizine HClCETIRIZINE HCLAMERISOURCE BERGEN518ed897-7365-0520-e063-6394a90a06d62026-05-11WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINE HCLTOP CARE (Topco Associates LLC)3363bd32-cac6-e10c-e063-6294a90a26382026-05-11WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESportpharm LLC357523b6-618b-4bff-a80d-c62e72a0804e2026-05-08WarningsExact identifier
unii: 64O047KTOA
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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