careone childrens allergy relief

Product NDC: 41520-902
11-digit product format: 415200902
Labeler code: 41520
Product ID: 41520-902_10d54909-6779-4ef2-b41e-50c4a34d3494
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: American Sales Company
Application: ANDA204226
Marketing category: ANDA
Marketing start: 2016-06-23
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41520-902	41520-902-34	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41520-902	41520-902-34	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41520-902	41520-902-34	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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: careone childrens allergy relief
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
0582736b-e129-4048-967c-6270c776f9db	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41520-902-26	careone childrens allergy relief	1 in 1 CARTON	SOLUTION	1	4
41520-902-26	careone childrens allergy relief	118 mL in 1 BOTTLE	SOLUTION	118	4
41520-902-34	careone childrens allergy relief	1 in 1 CARTON	SOLUTION	1	4
41520-902-34	careone childrens allergy relief	240 mL in 1 BOTTLE	SOLUTION	240	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-902	CAREONE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [AMERICAN SALES COMPANY]	3	Current NDC, Legacy NDC, 4 package rows	20181218_0582736b-e129-4048-967c-6270c776f9db.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 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
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
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
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

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	0582736b-e129-4048-967c-6270c776f9db	4
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	0582736b-e129-4048-967c-6270c776f9db	4
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	0582736b-e129-4048-967c-6270c776f9db	4
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	0582736b-e129-4048-967c-6270c776f9db	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-902-26	41520090226	1 BOTTLE in 1 CARTON (41520-902-26) / 118 mL in 1 BOTTLE	1 bottle	2016-06-23	0000-00-00	No	No	Current
41520-902-34	41520090234	1 BOTTLE in 1 CARTON (41520-902-34) > 240 mL in 1 BOTTLE	1 bottle	2016-06-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Children’s Allergy Relief Drug Facts	American Sales Company	2025-06-12	HUMAN OTC DRUG LABEL	4