Zyrtec Allergy

Product NDC
50580-752
11-digit product format
505800752
Labeler code
50580
Product ID
50580-752_40a49b40-f7f1-74c3-e063-6294a90a55ed
Type
HUMAN OTC DRUG
Nonproprietary name
cetirizine hydrochloride
Dosage form
KIT
Labeler
Kenvue Brands LLC
Application
NDA019835
Marketing category
NDA
Marketing start
2020-06-15
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1014678, 1020026

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
50580-726-50Zyrtec Allergy1 in 1 PACKAGETABLET, FILM COATED10 mg8
50580-726-50Zyrtec Allergy50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5010 mg8
50580-726-70Zyrtec Allergy1 in 1 PACKAGETABLET, FILM COATED10 mg8
50580-726-70Zyrtec Allergy70 in 1 BOTTLE, PLASTICTABLET, FILM COATED7010 mg8
50580-752-01Zyrtec Allergy1 in 1 PACKAGEKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-752ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 5 package rows20241114_6685a843-9dbe-4f9e-b75b-fe0e258f4155.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN6685a843-9dbe-4f9e-b75b-fe0e258f41558
1020026ZyrTEC 10 MG Oral TabletPSN6685a843-9dbe-4f9e-b75b-fe0e258f41558
1020026cetirizine hydrochloride 10 MG Oral Tablet [Zyrtec]SBD6685a843-9dbe-4f9e-b75b-fe0e258f41558
1014678cetirizine hydrochloride 10 MG Oral TabletSCD6685a843-9dbe-4f9e-b75b-fe0e258f41558
1014678cetirizine HCl 10 MG Oral TabletSY6685a843-9dbe-4f9e-b75b-fe0e258f41558
1020026Zyrtec (cetirizine dihydrochloride 10 MG) Oral TabletSY6685a843-9dbe-4f9e-b75b-fe0e258f41558
1020026Zyrtec 10 MG Oral TabletSY6685a843-9dbe-4f9e-b75b-fe0e258f41558

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-726-50505800726501 in 1 PACKAGEHistorical
50580-726-70505800726701 in 1 PACKAGEHistorical
50580-752-01505800752011 KIT in 1 PACKAGE (50580-752-01) * 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1 kit2020-06-150000-00-00NoNoCurrent