Application 204226

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2013-09-09

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2013-09-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`f41ea6bd6efb…`

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 3 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DG Health Childrens All Day Allergy	CETIRIZINE HCL	Dolgencorp, LLC	9cdccfec-4373-452b-a574-f40b2a97f370	2022-02-03	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226 ndc (product): 55910-714
Basic Care Childrens All Day Allergy	CETIRIZINE HCL	Amazon.com Services LLC	6cf67d32-5e61-42f4-9123-ab8debdfec4f	2021-08-23	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Leader Childrens All Day Allergy	CETIRIZINE HCL	Cardinal Health 110, LLC. dba Leader	b11080bf-5916-497d-966a-eb13191a6b87	2021-06-17	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226 ndc (product): 70000-0214
childrens all day allergy	CETIRIZINE HCL	Kroger Company	2d95549e-2dce-4f88-adfb-aaae0cc130b6	2020-08-17	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226 ndc (product): 30142-189
Topcare Childrens All Day Allergy	CETIRIZINE HCL	Topco Associates LLC	d29e50bc-75fe-437e-98a5-e0446919fcd6	2019-11-21	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226 ndc (product): 36800-189

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 2 · 94 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0189	Good Sense Childrens All Day Allergy	Cetirizine HCl	L. Perrigo Company	ANDA	Current
0113-0189	Good Sense Childrens All Day Allergy	Cetirizine HCl	L. Perrigo Company	ANDA	Current
0113-0503	Good Sense Childrens All Day Allergy	Cetirizine HCl	L. Perrigo Company	ANDA	Current
0113-7189	basic care childrens all day allergy	Cetirizine HCl	L. Perrigo Company	ANDA	Current
0113-7189	basic care childrens all day allergy	Cetirizine HCl	L. Perrigo Company	ANDA	Current
0113-7475	basic care childrens all day allergy	Cetirizine HCl	L. Perrigo Company	ANDA	Current
0113-7475	basic care childrens all day allergy	Cetirizine HCl	L. Perrigo Company	ANDA	Current
0363-0475	childrens wal zyr	Cetirizine HCl	Walgreen Company	ANDA	Current
0363-0475	childrens wal zyr	Cetirizine HCl	Walgreen Company	ANDA	Current
0363-0545	Wal Zyr	Cetirizine HCl	Walgreen Company	ANDA	Current
0363-0545	Wal Zyr	Cetirizine HCl	Walgreen Company	ANDA	Current
0363-0953	Childrens Dye Free Wal Zyr	Cetirizine HCl	Walgreen Company	ANDA	Current
0363-0953	Childrens Dye Free Wal Zyr	Cetirizine HCl	Walgreen Company	ANDA	Current
0363-1475	childrens dye free wal zyr	Cetirizine HCl	Walgreen Company	ANDA	Current
0363-3311	childrens allergy relief	Cetirizine Hydrochloride	Walgreen Company	ANDA	Current
0363-3393	childrens allergy relief	Cetirizine Hydrochloride	Walgreen Company	ANDA	Current
0904-6765	childrens cetirizine hydrochloride	Cetirizine HCl	Major Pharmaceuticals	ANDA	Current
0904-6765	childrens cetirizine hydrochloride	Cetirizine HCl	Major Pharmaceuticals	ANDA	Current
11673-303	up and up childrens allergy relief	Cetirizine HCl	Target Corporation	ANDA	Current
11673-303	up and up childrens allergy relief	Cetirizine HCl	Target Corporation	ANDA	Current
11673-303	up and up childrens allergy relief	Cetirizine HCl	Target Corporation	ANDA	Current
11673-475	Up and Up Childrens Allergy Relief	Cetirizine HCl	Target Corporation	ANDA	Current
11822-0475	childrens allergy relief	Cetirizine HCl	Rite Aid Corporation	ANDA	Current
11822-0475	childrens allergy relief	Cetirizine HCl	Rite Aid Corporation	ANDA	Current
11822-0475	childrens allergy relief	Cetirizine HCl	Rite Aid Corporation	ANDA	Current
11822-1189	childrens allergy relief	Cetirizine HCl	Rite Aid Corporation	ANDA	Current
21130-189	Signature Care Childrens Allergy Relief	Cetirizine HCl	Safeway	ANDA	Current
21130-475	Signature Care Childrens Allergy Relief	Cetirizine HCl	Safeway	ANDA	Current
30142-189	childrens all day allergy	Cetirizine HCl	Kroger Company	ANDA	Current
30142-189	childrens all day allergy	Cetirizine HCl	Kroger Company	ANDA	Current
30142-475	Childrens All Day Allergy	Cetirizine HCl	Kroger Company	ANDA	Current
30142-475	Childrens All Day Allergy	Cetirizine HCl	Kroger Company	ANDA	Current
36800-189	Topcare Childrens All Day Allergy	Cetirizine HCl	Topco Associates LLC	ANDA	Current
36800-189	Topcare Childrens All Day Allergy	Cetirizine HCl	Topco Associates LLC	ANDA	Current
36800-475	TopCare Childrens All Day Allergy	Cetirizine HCl	Topco Associates LLC	ANDA	Current
36800-475	TopCare Childrens All Day Allergy	Cetirizine HCl	Topco Associates LLC	ANDA	Current
37012-475	Childrens Allergy Relief	Cetirizine HCl	Shopko Stores Operating Co., LLC	ANDA	Current
41163-475	Equaline childrens all day allergy	Cetirizine HCl	Supervalu Inc	ANDA	Current
41190-475	ShopRite Childrens Allergy	Cetirizine HCl	Wakefern Food Corporation	ANDA	Current
41250-189	Childrens 24 Hour Allergy	Cetirizine HCl	Meijer Distribution Inc	ANDA	Current
41250-189	Childrens 24 Hour Allergy	Cetirizine HCl	Meijer Distribution Inc	ANDA	Current
41250-189	Childrens 24 Hour Allergy	Cetirizine HCl	Meijer Distribution Inc	ANDA	Current
41250-475	Childrens 24 Hour Allergy	Cetirizine HCl	Meijer Distribution Inc	ANDA	Current
41250-475	Childrens 24 Hour Allergy	Cetirizine HCl	Meijer Distribution Inc	ANDA	Current
41250-475	Childrens 24 Hour Allergy	Cetirizine HCl	Meijer Distribution Inc	ANDA	Current
41250-475	Childrens 24 Hour Allergy	Cetirizine HCl	Meijer Distribution Inc	ANDA	Current
41250-475	Childrens 24 Hour Allergy	Cetirizine HCl	Meijer Distribution Inc	ANDA	Current
41520-301	careone childrens allergy relief	Cetirizine HCl	American Sales Company	ANDA	Current
41520-301	careone childrens allergy relief	Cetirizine HCl	American Sales Company	ANDA	Current
41520-902	careone childrens allergy relief	Cetirizine HCl	American Sales Company	ANDA	Current
42507-203	Childrens All Day Allergy	Cetirizine HCl	HyVee Inc	ANDA	Current
42507-475	childrens all day allergy	Cetirizine HCl	HyVee Inc	ANDA	Current
46122-203	Good Neighbor Pharmacy Childrens All Day Allergy	Cetirizine HCl	Amerisource Bergen	ANDA	Current
49738-031	Smart Sense Allergy Relief	Cetirizine HCl	Kmart Corporation	ANDA	Current
49738-189	Smart Sense Childrens Allergy	Cetirizine HCl	Kmart Corporation	ANDA	Current
49738-475	smart sense allergy relief	Cetirizine HCl	Kmart Corporation	ANDA	Current
55312-475	Allergy	Cetirizine HCl	Western Family Foods Inc	ANDA	Current
55316-475	Healthy Accents Childrens Allergy	Cetirizine HCl	DZA Brands LLC	ANDA	Current
55319-475	Family Wellness childrens All Day Allergy	Cetirizine HCl	Family Dollar Services Inc	ANDA	Current
55319-901	family wellness childrens allergy	Cetirizine Hydrochloride	Family Dollar Services Inc	ANDA	Current
55910-475	rexall all day allergy relief	Cetirizine HCl	Dolgencorp, LLC	ANDA	Current
55910-714	DG Health Childrens All Day Allergy	Cetirizine HCl	Dolgencorp, LLC	ANDA	Current
55910-714	DG Health Childrens All Day Allergy	Cetirizine HCl	Dolgencorp, LLC	ANDA	Current
55910-714	DG Health Childrens All Day Allergy	Cetirizine HCl	Dolgencorp, LLC	ANDA	Current
56062-475	childrens allergy	Cetirizine HCl	Publix Super Markets Inc	ANDA	Current
59779-509	Childrens Allergy Relief	Cetirizine HCl	CVS Pharmacy	ANDA	Current
59779-837	allergy relief	Cetirizine HCl	CVS Pharmacy	ANDA	Current
59779-837	allergy relief	Cetirizine HCl	CVS Pharmacy	ANDA	Current
62011-0322	Health Mart childrens all day allergy	Cetirizine HCl	Mckesson	ANDA	Current
62011-0322	Health Mart childrens all day allergy	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
62011-0322	Health Mart childrens all day allergy	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
62011-0323	Health Mart Childrens all day allergy	Cetirizine HCl	Mckesson	ANDA	Current
62011-0323	Health Mart Childrens all day allergy	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
62011-0323	Health Mart Childrens all day allergy	Cetirizine HCl	Strategic Sourcing Services LLC	ANDA	Current
63981-475	Kirkland Signature Childrens Aller Tec	Cetirizine HCl	Costco Wholesale Company	ANDA	Current
64024-475	Welby Childrens Allergy Relief	Cetirizine Hydrochloride	Aldi Inc	ANDA	Current
68094-004	Dye Free Childrens Cetirizine Hydrocholride	Cetirizine Hydrochloride	Precision Dose, Inc.	ANDA	Current
68788-8188	childrens cetirizine hydrochloride	Cetirizine HCl	Preferred Pharmaceuticals Inc.	ANDA	Current
69256-475	Harris Teeter Childrens All Day Allergy	Cetirizine HCl	Harris Teeter, LLC	ANDA	Current
70000-0214	Leader Childrens All Day Allergy	Cetirizine HCl	Cardinal Health	ANDA	Current