Childrens Zyrtec

Product NDC: 50580-790
Requested package NDC: 50580-790-01
11-digit product format: 505800790
Labeler code: 50580
Product ID: 50580-790_322eb217-089d-e92d-e063-6394a90a6566
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: 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

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021621-003	CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16
N021621-004	CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16
N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16
N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16
N021621-007	CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30

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.

Product history page 1 of 5 · 199 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
64O047KTOA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2558501	Internal RxNorm lookup
2558503	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
013ce40e-37c9-4b84-b530-ed895f60ce0e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-790-01	Childrens Zyrtec	6 in 1 BLISTER PACK	TABLET, CHEWABLE	6	8
50580-790-01	Childrens Zyrtec	2 in 1 CARTON	TABLET, CHEWABLE	2	8
50580-790-02	Childrens Zyrtec	4 in 1 CARTON	TABLET, CHEWABLE	4	8
50580-790-02	Childrens Zyrtec	6 in 1 BLISTER PACK	TABLET, CHEWABLE	6	8
50580-790-03	Childrens Zyrtec	6 in 1 BLISTER PACK	TABLET, CHEWABLE	6	8
50580-790-03	Childrens Zyrtec	1 in 1 CARTON	TABLET, CHEWABLE	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-790-01	EA - Each	50580-790	41760e2d-23a3-42a6-96a2-6acc34c14383	1	2022-08-04
50580-790-02	EA - Each	50580-790	9fff8865-570d-4cee-ba2a-f9eb9b772784	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-790	CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]	8	Current NDC, Legacy NDC, 6 package rows	20250410_013ce40e-37c9-4b84-b530-ed895f60ce0e.zip

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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zyrtec	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	dc613bd5-70fd-1d9b-e053-2995a90a41cd	2026-04-27	Warnings	Exact identifier application applno (NDA): 021621 application number: NDA021621
Childrens Zyrtec	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	0fe77356-d945-46a0-882e-b3bbab784556	2026-04-22	Warnings	Exact identifier application applno (NDA): 021621 application number: NDA021621
Childrens Zyrtec	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	0adb3617-3528-4d64-a9ad-b4545ec9d7b9	2025-04-08	Warnings	Exact identifier application applno (NDA): 021621 application number: NDA021621
Childrens Zyrtec	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	013ce40e-37c9-4b84-b530-ed895f60ce0e	2025-04-07	Warnings	Exact identifier application applno (NDA): 021621 application number: NDA021621 ndc (package): 50580-790-01 ndc (product): 50580-790 ndc11 (package): 50580079001
CHILDRENS ZYRTEC	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	5c19a07e-09f4-46ed-939c-d21fe3e811f6	2025-03-03	Warnings	Exact identifier application applno (NDA): 021621 application number: NDA021621

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
64O047KTOA	CETIRIZINE HYDROCHLORIDE	83881-52-1	CETIRIZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2558501	cetirizine hydrochloride 2.5 MG Chewable Tablet	PSN	013ce40e-37c9-4b84-b530-ed895f60ce0e	8
2558503	ZyrTEC 2.5 MG Chewable Tablet	PSN	013ce40e-37c9-4b84-b530-ed895f60ce0e	8
2558503	cetirizine hydrochloride 2.5 MG Chewable Tablet [Zyrtec]	SBD	013ce40e-37c9-4b84-b530-ed895f60ce0e	8
2558501	cetirizine hydrochloride 2.5 MG Chewable Tablet	SCD	013ce40e-37c9-4b84-b530-ed895f60ce0e	8
2558503	Zyrtec 2.5 MG Chewable Tablet	SY	013ce40e-37c9-4b84-b530-ed895f60ce0e	8
2558501	cetirizine hydrochloride 2.5 MG Chewable Tablet	PSN	0adb3617-3528-4d64-a9ad-b4545ec9d7b9	3
2558503	ZyrTEC 2.5 MG Chewable Tablet	PSN	0adb3617-3528-4d64-a9ad-b4545ec9d7b9	3
2558503	cetirizine hydrochloride 2.5 MG Chewable Tablet [Zyrtec]	SBD	0adb3617-3528-4d64-a9ad-b4545ec9d7b9	3
2558501	cetirizine hydrochloride 2.5 MG Chewable Tablet	SCD	0adb3617-3528-4d64-a9ad-b4545ec9d7b9	3
2558503	Zyrtec 2.5 MG Chewable Tablet	SY	0adb3617-3528-4d64-a9ad-b4545ec9d7b9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-790-01	50580079001	2 BLISTER PACK in 1 CARTON (50580-790-01) / 6 TABLET, CHEWABLE in 1 BLISTER PACK	2 blister pack	2021-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Zyrtec Chewable Tablets 2.5mg	A-S Medication Solutions	2025-04-08	HUMAN OTC DRUG LABEL	3
Children's Zyrtec Chewable Tablets 2.5mg	Kenvue Brands LLC	2025-04-07	HUMAN OTC DRUG LABEL	8