Childrens Zyrtec

Product NDC
50090-6845
11-digit product format
500906845
Labeler code
50090
Product ID
50090-6845_d1013fc5-5b6e-4db9-98c5-6d8a205a1c8f
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021621
Marketing category
NDA
Marketing start
2021-06-21
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
2.5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Zyrtec
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui2558501, 2558503

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6845-0Childrens Zyrtec4 in 1 CARTONTABLET, CHEWABLE43
50090-6845-0Childrens Zyrtec6 in 1 BLISTER PACKTABLET, CHEWABLE63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6845-0EA - Each50090-6845947863c1-5f45-482c-8657-f46799893a5312024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6845CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20250410_0adb3617-3528-4d64-a9ad-b4545ec9d7b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2558501cetirizine hydrochloride 2.5 MG Chewable TabletPSN0adb3617-3528-4d64-a9ad-b4545ec9d7b93
2558503ZyrTEC 2.5 MG Chewable TabletPSN0adb3617-3528-4d64-a9ad-b4545ec9d7b93
2558503cetirizine hydrochloride 2.5 MG Chewable Tablet [Zyrtec]SBD0adb3617-3528-4d64-a9ad-b4545ec9d7b93
2558501cetirizine hydrochloride 2.5 MG Chewable TabletSCD0adb3617-3528-4d64-a9ad-b4545ec9d7b93
2558503Zyrtec 2.5 MG Chewable TabletSY0adb3617-3528-4d64-a9ad-b4545ec9d7b93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6845-0500906845004 BLISTER PACK in 1 CARTON (50090-6845-0) / 6 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2023-11-29NoNoHistorical