Application 019835

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	No
004	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	Yes	Yes
005	ZYRTEC HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	No
006	ZYRTEC HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019835-003	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	2007-11-16
N019835-004	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RLD, RS	2007-11-16
N019835-005	ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	2007-11-16
N019835-006	ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RLD	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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`d8e5a09893c0…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Select Consumer Group	568960cf-2c8f-f1b0-e063-6294a90aebc7	2026-07-13	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Savings Distributors LLC	5490c38a-91d7-9ee1-e063-6394a90a1ea5	2026-06-01	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	b165db38-b302-4220-8627-77cb07bb078c	2025-10-10	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835 ndc (product): 50580-726
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	6685a843-9dbe-4f9e-b75b-fe0e258f4155	2025-10-08	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835 ndc (product): 50580-752
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	2c1ecee3-c2c1-25a2-e063-6294a90aad54	2025-07-21	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Morning Star OTC	3efa421d-ea70-4b1f-95d0-7c63b6c39580	2025-06-19	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
ZYRTEC Hives	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	31136e3a-94fa-0860-e063-6394a90a008d	2025-06-16	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	RedPharm Drug Inc	f4c1f9fd-2d32-71d3-e053-2a95a90a3ba4	2025-01-23	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec 1s Blister	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	3a595eb8-2409-4598-8704-ab59b57bd062	2024-12-31	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835 ndc (product): 50269-014
Zyrtec 2s Blister	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	af0ba7b0-b511-9f81-e053-2a95a90ade2c	2024-12-31	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835 ndc (product): 50269-019
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc	a4146629-57f0-42e0-b905-df364a8a99f5	2024-12-31	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy, Lil Drug Store	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED	Lil' Drug Store Products, Inc.	1b6c945f-591f-8869-e063-6294a90ad397	2024-06-21	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Navajo Manufacturing Company Incorporated	9c4693cb-f066-0666-e053-2a95a90a96d3	2023-03-16	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835 ndc (product): 67751-192

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16853-1305	ALLEROFF	Cetirizine Hydrochloride	Corporacion Infarmasa	NDA	Current
16853-1307	ALLEROFF	Cetirizine Hydrochloride	Corporacion Infarmasa	NDA	Current
46084-012	APTRIZINE	CETIRIZINE HYDROCHLORIDE	A P J Laboratories Limited	ANDA	Current
50269-014	Zyrtec 1s Blister	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	NDA	Current
50269-014	Zyrtec 1s Blister	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	NDA	Current
50269-019	Zyrtec 2s Blister	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	NDA	Current
50269-019	Zyrtec 2s Blister	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	NDA	Current
50580-726	Zyrtec Allergy	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-726	Zyrtec Allergy	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-726	Zyrtec Allergy	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-726	Zyrtec Allergy	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-726	Zyrtec Allergy	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-726	Zyrtec Allergy	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-726	Zyrtec Allergy	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-726	Zyrtec Allergy	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-726	Zyrtec Allergy	Cetirizine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-752	Zyrtec Allergy	cetirizine hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-752	Zyrtec Allergy	cetirizine hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-752	Zyrtec Allergy	cetirizine hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-752	Zyrtec Allergy	cetirizine hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
52904-961	Zyrtec Allergy	cetirizine hydrochloride	Select Corporation	NDA	Current
63629-2798	Zyrtec	Cetirizine Hydrochloride	Bryant Ranch Prepack	NDA	Current
67751-192	Zyrtec Allergy	Cetirizine Hydrochloride	Navajo Manufacturing Company Incorporated	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82210	SUPPL	2025-05-21
82096	SUPPL	2025-05-01
81746	SUPPL	2025-03-27
81741	SUPPL	2025-03-27
80444	SUPPL	2024-11-29
80443	SUPPL	2024-11-29
78020	SUPPL	2024-04-01
78019	SUPPL	2024-04-01
76867	SUPPL	2023-12-15
76724	SUPPL	2023-12-05
74200	SUPPL	2023-05-09
74199	SUPPL	2023-05-09
59628	SUPPL	2019-08-08
59627	SUPPL	2019-08-08
11750	SUPPL	2012-12-12
1670	SUPPL	2012-09-11
1669	SUPPL	2012-03-15
1668	SUPPL	2012-01-30
19276	SUPPL	2010-03-04
41055	SUPPL	2009-01-12
20386	SUPPL	2009-01-12
1667	SUPPL	2008-11-28
41056	SUPPL	2008-05-21
1666	SUPPL	2007-11-26
1665	SUPPL	2006-04-07
34000	SUPPL	2004-04-05
1664	SUPPL	2004-03-24
33999	SUPPL	2002-10-21
1663	SUPPL	2002-10-21
41054	SUPPL	1998-05-15
1662	SUPPL	1998-05-15
57426	ORIG	1995-12-08