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 8 of 39 · 768 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Allergy ReliefCETIRIZINE HCLBryant Ranch Prepack7e4a2d02-c2b3-4a1f-8373-a0b0dec5ddea2026-03-10WarningsExact identifier
unii: 64O047KTOA
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAdvagen Pharma Ltd.,0956baea-f0ad-4aac-9464-831840db92302026-03-06Adverse reactionsExact identifier
rxcui: 1014673
unii: 64O047KTOA
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
QUZYTTIRCETIRIZINE HYDROCHLORIDETerSera Therapeutics LLCf33e859d-ebc9-4d4f-a57d-204c48760d202026-03-04Warnings, Adverse reactionsExact identifier
unii: 64O047KTOA
Good Sense Childrens All Day AllergyCETIRIZINE HCLA-S Medication Solutions8c99c767-6b46-4819-89df-c02f478a45be2026-03-04WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSProficient Rx LP55b1738c-fa72-4cd1-a8e8-be41b12b593d2026-03-01WarningsExact identifier
unii: 64O047KTOA
allergy relief D12CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Companyaa515879-9851-4915-bd41-51d81e585dd72026-02-28WarningsExact identifier
unii: 64O047KTOA
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLCffbca2a4-8df0-4c85-adf9-9414cd706fb22026-02-26WarningsExact identifier
unii: 64O047KTOA
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: XF417D3PSL
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL
All Day Allergy ReliefCETIRIZINE HCLP & L Development, LLCc5dab2f3-8f95-4b85-995b-23b21c762ae82026-02-23WarningsExact identifier
unii: 64O047KTOA
All Day AllergyCETIRIZINE HCLWALMART INC. (see also Equate)c8016d34-aa72-4857-b5ed-5476948b386a2026-02-20WarningsExact identifier
unii: 64O047KTOA
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
ALLERGY RELIEF D12CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5b6cd5ba-bdca-434e-b024-0089aeeec6a12026-02-17WarningsExact identifier
unii: 64O047KTOA
childrens cetirizine hydrochlorideCETIRIZINE HCLMajor Pharmaceuticalsdb297aa4-4384-48f2-b2bd-c842efc8a8442026-02-13WarningsExact identifier
rxcui: 1014673
unii: 64O047KTOA
BERKLEY AND JENSEN ALL DAY ALLERGYCETIRIZINE HYDROCHLORIDEBJWCb38c0068-5b06-4976-b68d-617bcc14f0512026-02-11WarningsExact identifier
unii: 64O047KTOA
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESportpharm LLCdd50d2e9-3de7-4c44-96ed-39ef04dae7022026-02-06WarningsExact identifier
unii: 64O047KTOA

Reported adverse events (FAERS/openFDA)#

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