Childrens 24 Hour Allergy

Product NDC: 41250-475
11-digit product format: 412500475
Labeler code: 41250
Product ID: 41250-475_6b615779-697e-49e5-92f0-96be91b549b8
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: Meijer Distribution Inc
Application: ANDA204226
Marketing category: ANDA
Marketing start: 2015-12-02
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 5 mg/5mL
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 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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens 24 Hour Allergy
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	5 mg/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1014673	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
6a5549b3-e0a9-40e1-b80d-b81b2f1932c9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41250-475-00	Childrens 24 Hour Allergy	1 in 1 CARTON	SOLUTION	1	10
41250-475-00	Childrens 24 Hour Allergy	120 mL in 1 BOTTLE	SOLUTION	120	10
41250-475-26	Childrens 24 Hour Allergy	118 mL in 1 BOTTLE	SOLUTION	118	10
41250-475-26	Childrens 24 Hour Allergy	1 in 1 CARTON	SOLUTION	1	10
41250-475-34	Childrens 24 Hour Allergy	1 in 1 CARTON	SOLUTION	1	10
41250-475-34	Childrens 24 Hour Allergy	236 mL in 1 BOTTLE	SOLUTION	236	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41250-475-26	ML - Milliliter	41250-475	029e886c-324d-4cef-b98d-52075dce0b86	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-475	CHILDRENS 24 HOUR ALLERGY (CETIRIZINE HCL) SOLUTION [MEIJER DISTRIBUTION INC]	9	Current NDC, Legacy NDC, 6 package rows	20250430_6a5549b3-e0a9-40e1-b80d-b81b2f1932c9.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 2 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Childrens all day allergy	CETIRIZINE HCL	Cardinal Health 110, LLC. dba Leader	6e69ba49-a487-445b-b5f3-5e468d86ac44	2025-04-30	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Equaline childrens all day allergy	CETIRIZINE HCL	United Natural Foods, Inc. dba UNFI	edd4240d-f719-4336-88fe-0960cd8006e0	2025-04-30	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
TopCare Childrens All Day Allergy	CETIRIZINE HCL	Topco Associates LLC	48555c1f-8c2a-4ab2-9af3-d2488ca509e4	2025-04-29	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens allergy relief	CETIRIZINE HYDROCHLORIDE	Walgreen Company	5cdd59a0-4d23-4f51-9aca-d66a639f8472	2025-04-29	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Childrens All Day Allergy	CETIRIZINE HCL	Kroger Company	9526b509-40fb-4bab-b7b5-13ab600b728a	2025-04-29	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
basic care childrens all day allergy	CETIRIZINE HCL	Amazon.com Services LLC	e32a86d9-e992-4212-b503-dcda524672a2	2025-04-29	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens allergy relief	CETIRIZINE HYDROCHLORIDE	Walgreen Company	2a62f905-663f-4aae-991f-a368b5120f6f	2025-04-24	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Good Sense Childrens All Day Allergy	CETIRIZINE HCL	L. Perrigo Company	19120ef7-e9ca-435d-beab-6278b5756d6b	2025-03-14	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Dye Free Childrens Cetirizine Hydrocholride	CETIRIZINE HCL	Precision Dose, Inc.	6a7c4dff-66c6-4d0c-af10-d908c65a43be	2025-02-12	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Good Sense Childrens All Day Allergy	CETIRIZINE HCL	Preferred Pharmaceuticals Inc.	0be90b3d-be71-4d38-bbf7-bf89a647ca8e	2025-01-20	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Good Neighbor Pharmacy Childrens All Day Allergy	CETIRIZINE HCL	Amerisource Bergen	c6951587-fe03-4bc8-8f0c-0687d49f7159	2025-01-03	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Members Mark Childrens Cetirizine	CETIRIZINE HYDROCHLORIDE	Sam's West Inc	9c6e7a8b-f8ad-4f6b-abb1-5cde86b75c7d	2024-09-25	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens allergy relief	CETIRIZINE HYDROCHLORIDE	Safeway	5d3e4c52-b697-4b91-af28-124f74d937e5	2024-08-02	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
up and up childrens allergy	CETIRIZINE HYDROCHLORIDE	Target Corporation	4b1ee9b1-d22e-4fb2-8dcd-912374da12d7	2024-06-06	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
up and up childrens allergy	CETIRIZINE HYDROCHLORIDE	Target Corporation	1f37c327-cd4c-4bc1-ae70-713569694e2e	2024-06-04	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens allergy relief	CETIRIZINE HYDROCHLORIDE	Safeway	cfc3daa5-7248-4105-95ee-4e19199655ce	2024-04-30	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
foster and thrive childrens allergy relief	CETIRIZINE HCL	Strategic Sourcing Services LLC	dc201cee-dbc3-4f28-babe-8e48ab79f4ab	2023-09-20	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Kirkland Signature Childrens Aller Tec	CETIRIZINE HCL	Costco Wholesale Company	eb14a311-7918-4c4b-ae05-7606cfb8a4af	2023-05-04	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens cetirizine hydrochloride	CETIRIZINE HCL	Proficient Rx LP	8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e	2022-11-01	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Welby Childrens Allergy Relief	CETIRIZINE HYDROCHLORIDE	Aldi Inc	a8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a	2022-10-13	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226

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
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	6a5549b3-e0a9-40e1-b80d-b81b2f1932c9	10
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	6a5549b3-e0a9-40e1-b80d-b81b2f1932c9	10
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	6a5549b3-e0a9-40e1-b80d-b81b2f1932c9	10
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	6a5549b3-e0a9-40e1-b80d-b81b2f1932c9	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-475-00	41250047500	1 BOTTLE in 1 CARTON (41250-475-00) / 120 mL in 1 BOTTLE	1 bottle	2025-06-10		No	No	Current
41250-475-26	41250047526	1 BOTTLE in 1 CARTON (41250-475-26) / 118 mL in 1 BOTTLE	1 bottle	2015-12-02	0000-00-00	No	No	Current
41250-475-34	41250047534	1 BOTTLE in 1 CARTON (41250-475-34) / 236 mL in 1 BOTTLE	1 bottle	2015-12-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Children’s 24 Hour Allergy Drug Facts	Meijer Distribution Inc	2025-06-25	HUMAN OTC DRUG LABEL	10