Application 022155

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S ZYRTEC HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	Yes	Yes
002	CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022155-001	CHILDREN'S ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD, RS	2007-11-16
N022155-002	CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD, RS	2007-11-16

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`74a2ff9319b5…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	2026-01-19	Warnings	Exact identifier application applno (NDA): 022155 application number: NDA022155 ndc (product): 50580-721
Childrens Zyrtec	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	9d8e78ea-af98-4f7c-8db5-044b49582f80	2025-10-10	Warnings	Exact identifier application applno (NDA): 022155 application number: NDA022155 ndc (product): 50580-730
ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	31400cb2-fe85-ef74-e063-6294a90a11fb	2025-06-16	Warnings	Exact identifier application applno (NDA): 022155 application number: NDA022155

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16853-1261	ALLEROFF	Cetirizine Hydrochloride	Corporacion Infarmasa	NDA	Current
50580-721	Childrens Zyrtec Allergy	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-721	Childrens Zyrtec Allergy	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-730	Childrens Zyrtec	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-730	Childrens Zyrtec	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-730	Childrens Zyrtec	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-730	Childrens Zyrtec	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84608	SUPPL	2025-12-31
84605	SUPPL	2025-12-31
80887	SUPPL	2025-01-21
80214	SUPPL	2025-01-21
80446	SUPPL	2024-11-29
80445	SUPPL	2024-11-29
55943	SUPPL	2018-10-15
55925	SUPPL	2018-10-15
38315	SUPPL	2016-04-20
6980	SUPPL	2016-04-18
6979	SUPPL	2014-05-20
17027	SUPPL	2014-05-19
29332	SUPPL	2012-05-24
6978	SUPPL	2009-03-17
6977	SUPPL	2009-03-05
6976	SUPPL	2008-08-19
6975	SUPPL	2008-08-19
42432	ORIG	2008-05-21
6974	ORIG	2007-11-26