Application 090182

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	No	No
002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML	No	No

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

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
A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2008-04-22
A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2008-04-22

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2008-04-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2008-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2008-04-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2008-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2008-04-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2008-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2008-04-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2008-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2008-04-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2008-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2008-04-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2008-04-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090182-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2008-04-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090182-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2008-04-22	`782e0a99824c…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate Childrens Allergy Relief	CETIRIZINE HYDROCHLORIDE	Wal-Mart Stores Inc	b73950f4-af6f-4dc7-bce2-9ec43c45eee5	2026-06-12	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182 ndc (product): 49035-276
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	30cbaa91-2216-efd2-e063-6294a90aaaed	2026-06-07	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182
HEB Allergy Relief	CETIRIZINE HYDROCHLORIDE	H E B	9abdae64-4c3d-47f3-8224-fc81f7bfe557	2026-05-31	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182 ndc (product): 37808-102
Childrens Cetirizine Hydrochloride Sugar Free Grape	CETIRIZINE HYDROCHLORIDE	VERITYRX, LLC	42a1168e-e2cd-a1e5-e063-6294a90ab3b6	2025-11-02	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182
childrens allergy	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	ae216d0b-8ccc-4cc4-82f4-4d0f3a256822	2025-07-15	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182 ndc (product): 56062-102
Premier Value Childrens Cetirizine	CETIRIZINE HYDROCHLORIDE	Pharmacy Value Alliance LLC	a4931f0b-86f2-42c5-b2df-b359bb46f44a	2025-07-11	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182 ndc (product): 68016-165
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	601c2846-30e7-40f1-96b4-64fbed719c0b	2025-07-10	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free Grape	CETIRIZINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	54d72d7a-1f5b-4b36-bf76-ab7aef6243ab	2025-07-02	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182 ndc (product): 51672-2102
SIMPLY RIGHT childrens cetirizine	CETIRIZINE HYDROCHLORIDE	Sam's West Inc	48b47541-cf0c-48a7-9a65-2158fd1284f1	2024-06-24	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182 ndc (product): 68196-102
Childrens Cetirizine Hydrochloride Sugar Free Grape	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	016b66fd-dde9-4f13-afaf-a8aafbdeed1a	2024-01-23	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free Grape	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	582db483-394e-4c00-8522-4041a11696e4	2022-10-01	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182 ndc (product): 71205-705
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Chain Drug Consortium, LLC (Premier Value)	b47b0c8b-59d5-4e17-95be-a992c6861ee7	2019-01-23	Warnings	Exact identifier application applno (ANDA): 090182 application number: ANDA090182 ndc (product): 68016-023

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-2088	Wal-Zyr	Cetirizine Hydrochloride	Walgreen Company	ANDA	Current
0363-2102	Wal-Zyr	Cetirizine Hydrochloride	Walgreen Company	ANDA	Current
0363-2102	Wal-Zyr	Cetirizine Hydrochloride	Walgreen Company	ANDA	Current
11673-102	Target Childrens All Day Allergy Relief	Cetirizine Hydrochloride	Target Corporation	ANDA	Current
11673-208	Childrens All Day Allergy Relief	Cetirizine Hydrochloride	Target Corporation	ANDA	Current
11822-0279	Rite Aid	Cetirizine Hydrochloride	Rite Aid Corporation	ANDA	Current
11822-2102	Rite Aid	Cetirizine Hydrochloride	Rite Aid Corporation	ANDA	Current
11822-2102	Rite Aid	Cetirizine Hydrochloride	Rite Aid Corporation	ANDA	Current
11822-2102	Rite Aid	Cetirizine Hydrochloride	Rite Aid Corporation	ANDA	Current
30142-102	Childrens	Cetirizine Hydrochloride	Kroger Company	ANDA	Current
37808-102	HEB	Cetirizine Hydrochloride	H E B	ANDA	Current
37808-208	H-E-B	Cetirizine Hydrochloride	H E B	ANDA	Current
41250-102	Childrens	Cetirizine Hydrochloride	Meijer Distribution Inc	ANDA	Current
49035-088	Childrens Allergy Relief	Cetirizine Hydrochloride	Wal-Mart Stores Inc	ANDA	Current
49035-276	Equate	Cetirizine Hydrochloride	Wal-Mart Stores Inc	ANDA	Current
49035-276	Equate	Cetirizine Hydrochloride	Wal-Mart Stores Inc	ANDA	Current
49348-326	sunmark	Cetirizine Hydrochloride	McKesson	ANDA	Current
49348-972	Childrens	Cetirizine Hydrochloride	McKesson	ANDA	Current
51672-2088	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2088	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2102	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2102	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2102	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
52183-088	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Blacksmith Brands Inc.	ANDA	Current
55319-104	Childrens All Day Allergy	Cetirizine Hydrochloride	FAMILY WELLNESS	ANDA	Current
55319-104	Childrens All Day Allergy	Cetirizine Hydrochloride	FAMILY WELLNESS	ANDA	Current
56062-102	childrens allergy	Cetirizine Hydrochloride	Publix Super Markets Inc	ANDA	Current
56062-102	childrens allergy	Cetirizine Hydrochloride	Publix Super Markets Inc	ANDA	Current
59779-276	CVS Pharmacy	Cetirizine Hydrochloride	CVS Pharmacy	ANDA	Current
61715-157	Childrens Allergy Relief	Cetirizine Hydrochloride	Preferred Plus (Kinray)	ANDA	Current
62011-0051	Health Mart Pharmacy Childrens Cetirizine Hydrochloride	Cetirizine hydrochloride	Health Mart	ANDA	Current
62011-0180	HealthMart	Cetirizine Hydrochloride	McKesson	ANDA	Current
63868-093	Quality Choice Childrens Allergy Relief	Cetirizine Hydrochloride	Chain Drug Marketing Association Inc.	ANDA	Current
63868-133	Quality Choice	Cetirizine Hydrochloride	Chain Drug Marketing Association	ANDA	Current
63941-088	Best Choice	Cetirizine Hydrochloride	Valu Merchandisers Company	ANDA	Current
63941-102	Best Choice	Cetirizine Hydrochloride	Valu Merchandisers Company	ANDA	Current
68016-023	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	Chain Drug Consortium, LLC (Premier Value)	ANDA	Current
68016-165	Premier Value	Cetirizine Hydrochloride	Pharmacy Value Alliance LLC	ANDA	Current
68071-4433	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68196-102	SIMPLY RIGHT	Cetirizine Hydrochloride	Sam's West Inc	ANDA	Current
68196-102	SIMPLY RIGHT	Cetirizine Hydrochloride	Sam's West Inc	ANDA	Current
68196-102	SIMPLY RIGHT	Cetirizine Hydrochloride	Sam's West Inc	ANDA	Current
68196-102	SIMPLY RIGHT	Cetirizine Hydrochloride	Sam's West Inc	ANDA	Current
68788-8992	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8992	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8992	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9734	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-705	Childrens Cetirizine Hydrochloride	Cetirizine Hydrochloride	Proficient Rx LP	ANDA	Current