FDA.reportPublic FDA data

Childrens Zyrtec

Product NDC
50580-791
11-digit product format
505800791
Labeler code
50580
Product ID
50580-791_500a1503-02c8-cc05-e063-6394a90a24fb
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA021621
Marketing category
NDA
Marketing start
2021-06-21
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014674, 1020022

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
50580-791-01Childrens Zyrtec4 in 1 CARTONTABLET, CHEWABLE414
50580-791-01Childrens Zyrtec6 in 1 BLISTER PACKTABLET, CHEWABLE614
50580-791-02Childrens Zyrtec8 in 1 CARTONTABLET, CHEWABLE814
50580-791-02Childrens Zyrtec6 in 1 BLISTER PACKTABLET, CHEWABLE614
50580-791-03Childrens Zyrtec1 in 1 CARTONTABLET, CHEWABLE114
50580-791-03Childrens Zyrtec6 in 1 BLISTER PACKTABLET, CHEWABLE614
50580-791-72Childrens Zyrtec3 in 1 CARTONTABLET, CHEWABLE314
50580-791-72Childrens Zyrtec24 in 1 BLISTER PACKTABLET, CHEWABLE2414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-791-01EA - Each50580-7912df7db41-61d7-4756-be60-253c6254843b12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-791CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]12Current NDC, Legacy NDC, 8 package rows20250410_0fe77356-d945-46a0-882e-b3bbab784556.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014674cetirizine HCl 10 MG Chewable TabletPSN0fe77356-d945-46a0-882e-b3bbab78455614
1020022ZyrTEC 10 MG Chewable TabletPSN0fe77356-d945-46a0-882e-b3bbab78455614
1020022cetirizine hydrochloride 10 MG Chewable Tablet [Zyrtec]SBD0fe77356-d945-46a0-882e-b3bbab78455614
1014674cetirizine hydrochloride 10 MG Chewable TabletSCD0fe77356-d945-46a0-882e-b3bbab78455614
1020022Zyrtec 10 MG Chewable TabletSY0fe77356-d945-46a0-882e-b3bbab78455614
1014674cetirizine HCl 10 MG Chewable TabletPSN5c19a07e-09f4-46ed-939c-d21fe3e811f63
1020022ZyrTEC 10 MG Chewable TabletPSN5c19a07e-09f4-46ed-939c-d21fe3e811f63
1020022cetirizine hydrochloride 10 MG Chewable Tablet [Zyrtec]SBD5c19a07e-09f4-46ed-939c-d21fe3e811f63
1014674cetirizine hydrochloride 10 MG Chewable TabletSCD5c19a07e-09f4-46ed-939c-d21fe3e811f63
1020022Zyrtec 10 MG Chewable TabletSY5c19a07e-09f4-46ed-939c-d21fe3e811f63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-791-01505800791014 BLISTER PACK in 1 CARTON (50580-791-01) / 6 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2021-06-210000-00-00NoNoCurrent
50580-791-02505800791028 BLISTER PACK in 1 CARTON (50580-791-02) / 6 TABLET, CHEWABLE in 1 BLISTER PACK8 blister pack2023-01-010000-00-00NoNoCurrent
50580-791-03505800791031 BLISTER PACK in 1 CARTON (50580-791-03) / 6 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2022-09-010000-00-00NoNoCurrent
50580-791-72505800791723 BLISTER PACK in 1 CARTON (50580-791-72) / 24 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2024-01-15NoNoHistorical