Dye Free Childrens Cetirizine Hydrocholride

Product NDC: 68094-004
11-digit product format: 680940004
Labeler code: 68094
Product ID: 68094-004_16b6f804-4056-45a4-8764-8ca4256b3b43
Type: HUMAN OTC DRUG
Nonproprietary name: cetirizine hcl
Dosage form: SOLUTION
Route: ORAL
Labeler: Precision Dose, Inc.
Application: ANDA204226
Marketing category: ANDA
Marketing start: 2016-10-26
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 1.

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 · 41 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	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…`
2022-09-29 23:25 UTC	2022-09	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204226-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2013-09-09	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dye Free Childrens Cetirizine Hydrocholride
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
6a7c4dff-66c6-4d0c-af10-d908c65a43be	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
68094-004-59	Dye Free Childrens Cetirizine Hydrocholride	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	3
68094-004-62	Dye Free Childrens Cetirizine Hydrocholride	3 in 1 CASE	SOLUTION	3	3
68094-004-62	Dye Free Childrens Cetirizine Hydrocholride	10 in 1 TRAY	SOLUTION	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-004-59	ML - Milliliter	68094-004	8e34b6b0-7978-4b06-ac60-a9f2264fb5a7	1	2016-12-07
68094-004-62	ML - Milliliter	68094-004	7d4d1ee8-9f5e-4229-9669-99813953d170	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68094-004	DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE (CETIRIZINE HCL) SOLUTION [PRECISION DOSE, INC.]	3	Current NDC, Legacy NDC, 3 package rows	20250215_6a7c4dff-66c6-4d0c-af10-d908c65a43be.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 1 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHILDRENS ALL DAY ALLERGY	CETIRIZINE HCL	Amazon.com Services LLC	f9b17231-1787-4726-8e19-cf3430dd811c	2026-07-29	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens allergy relief	CETIRIZINE HCL	Rite Aid Corporation	978d8779-3c00-4b21-9cc3-f6a962194dfe	2026-07-24	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens allergy relief	CETIRIZINE HCL	Rite Aid Corporation	09474431-cf46-45da-8b20-9551ddea28a7	2026-07-24	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens dye free allergy relief	CETIRIZINE HCL	Kroger Company	2ecf7dac-97fd-49b3-87ce-9b473834bd7e	2026-05-01	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens cetirizine hydrochloride	CETIRIZINE HCL	ATLANTIC BIOLOGICALS CORP.	cb47e536-8eed-4a32-b9c2-e8535fb93886	2026-05-01	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens dye free allergy relief	CETIRIZINE HCL	Kroger Company	c6660c5c-1504-4a92-95e8-cc3a018e813b	2026-04-30	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Good Sense Childrens All Day Allergy	CETIRIZINE HCL	L. Perrigo Company	e56edd0e-4873-41bc-a727-05c02ec943ed	2026-04-20	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
careone childrens allergy relief	CETIRIZINE HCL	American Sales Company	a4e43301-3e03-4364-b303-645de1697572	2026-04-07	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens cetirizine hydrochloride	CETIRIZINE HCL	Preferred Pharmaceuticals Inc.	9e168299-5ba1-451a-8c85-3fbe34c36cb0	2026-03-25	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Good Sense Childrens All Day Allergy	CETIRIZINE HCL	Preferred Pharmaceuticals Inc.	8cf4615b-47f8-4b92-b0cd-16c380ad2320	2026-03-17	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Good Sense Childrens All Day Allergy	CETIRIZINE HCL	A-S Medication Solutions	8c99c767-6b46-4819-89df-c02f478a45be	2026-03-04	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens cetirizine hydrochloride	CETIRIZINE HCL	Major Pharmaceuticals	db297aa4-4384-48f2-b2bd-c842efc8a844	2026-02-13	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Childrens All Day Allergy	CETIRIZINE HCL	HyVee Inc	178743fd-5336-4aae-9a0a-5ff17aeb3762	2026-01-27	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
childrens all day allergy	CETIRIZINE HCL	HyVee Inc	2643640e-d144-41ae-919f-37be23e547aa	2026-01-27	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Childrens 24 Hour Allergy	CETIRIZINE HCL	Meijer Distribution Inc	4fba7f23-8123-4704-97a9-2c5d1e7e289a	2025-07-30	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
Childrens 24 Hour Allergy	CETIRIZINE HCL	Meijer Distribution Inc	6a5549b3-e0a9-40e1-b80d-b81b2f1932c9	2025-06-25	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
careone childrens allergy relief	CETIRIZINE HCL	American Sales Company	0582736b-e129-4048-967c-6270c776f9db	2025-06-12	Warnings	Exact identifier application applno (ANDA): 204226 application number: ANDA204226
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

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	6a7c4dff-66c6-4d0c-af10-d908c65a43be	3
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	6a7c4dff-66c6-4d0c-af10-d908c65a43be	3
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	6a7c4dff-66c6-4d0c-af10-d908c65a43be	3
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	6a7c4dff-66c6-4d0c-af10-d908c65a43be	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68094-004-59	68094000459	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
68094-004-62	68094000462	3 TRAY in 1 CASE (68094-004-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-004-59)	3 tray	2016-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dye Free Children's Cetirizine Hydrochloride Oral Solution	Precision Dose, Inc.	2025-02-12	HUMAN OTC DRUG LABEL	3