FDA.reportPublic FDA data

Childrens Zyrtec Allergy

Product NDC
50580-721
Requested package NDC
50580-721-05
11-digit product format
505800721
Labeler code
50580
Product ID
50580-721_48bb7dd3-c2b8-ecfb-e063-6294a90af77d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA022155
Marketing category
NDA
Marketing start
2009-01-20
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022155-001CHILDREN'S ZYRTEC HIVESCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD, RS2007-11-16
N022155-002CHILDREN'S ZYRTEC ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD, RS2007-11-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-16a50c72e98297…
2026-08-01 22:54:322026-06N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLCee8695ac-1293-4e43-ac7c-a64e21a0ca0a2026-01-19WarningsExact identifier
application applno (NDA): 022155
application number: NDA022155
ndc (package): 50580-721-05
ndc (product): 50580-721
ndc11 (package): 50580072105
Childrens ZyrtecCETIRIZINE HYDROCHLORIDEKenvue Brands LLC9d8e78ea-af98-4f7c-8db5-044b49582f802025-10-10WarningsExact identifier
application applno (NDA): 022155
application number: NDA022155
ZYRTEC HIVESCETIRIZINE HYDROCHLORIDEKenvue Brands LLC31400cb2-fe85-ef74-e063-6294a90a11fb2025-06-16WarningsExact identifier
application applno (NDA): 022155
application number: NDA022155

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Zyrtec Allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64O047KTOAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014673Internal RxNorm lookup
1020021Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee8695ac-1293-4e43-ac7c-a64e21a0ca0aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-721-05Childrens Zyrtec Allergy118 mL in 1 BOTTLE, PLASTICSYRUP11810
50580-721-05Childrens Zyrtec Allergy1 in 1 CARTONSYRUP110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-721-04ML - Milliliter50580-721f9512a1d-f76a-4184-baea-882afa73608112015-10-02
50580-721-05ML - Milliliter50580-72117d2c830-f0df-412d-9d9a-81798d1a957a12017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOACHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
CetirizineACTIVE MOIETYYO7261ME24CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-721CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [KENVUE BRANDS LLC]8Current NDC, Legacy NDC, 2 package rows20250515_ee8695ac-1293-4e43-ac7c-a64e21a0ca0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNee8695ac-1293-4e43-ac7c-a64e21a0ca0a10
1020021ZyrTEC 5 MG in 5 mL Oral SolutionPSNee8695ac-1293-4e43-ac7c-a64e21a0ca0a10
1020021cetirizine hydrochloride 1 MG/ML Oral Solution [Zyrtec]SBDee8695ac-1293-4e43-ac7c-a64e21a0ca0a10
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDee8695ac-1293-4e43-ac7c-a64e21a0ca0a10
1014673cetirizine HCl 1 MG/ML Oral SyrupSYee8695ac-1293-4e43-ac7c-a64e21a0ca0a10
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYee8695ac-1293-4e43-ac7c-a64e21a0ca0a10
1020021Children's Zyrtec 5 MG per 5 ML Medicated SpoonSYee8695ac-1293-4e43-ac7c-a64e21a0ca0a10
1020021Zyrtec 1 MG/ML Oral SolutionSYee8695ac-1293-4e43-ac7c-a64e21a0ca0a10
1020021Zyrtec Children's 5 MG per 5 ML SyrupSYee8695ac-1293-4e43-ac7c-a64e21a0ca0a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50580-721-05505800721051 BOTTLE, PLASTIC in 1 CARTON (50580-721-05) / 118 mL in 1 BOTTLE, PLASTIC2015-07-130000-00-00NoNoCurrent