Childrens All Day Allergy

Product NDC: 55319-104
11-digit product format: 553190104
Labeler code: 55319
Product ID: 55319-104_41351eab-bda3-4147-aa04-89321a32ed4b
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SUSPENSION
Route: ORAL
Labeler: FAMILY WELLNESS
Application: ANDA090182
Marketing category: ANDA
Marketing start: 2008-04-22
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55319-104		I	Inactivated by FDA	2026-08-03
excluded package	package	55319-104	55319-104-07	I	Inactivated by FDA	2026-08-03
excluded package	package	55319-104	55319-104-08	I	Inactivated by FDA	2026-08-03

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55319-104-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55319-104-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55319-104-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55319-104-08	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55319-104-07	2025-07-29	C162847	48780-1	3b156c62-2fdf-fb37-e063-e6dba90a4e07	Children's All Day Allergy Sugar Free Grape
55319-104-08	2025-07-29	C162847	48780-1	3b156c62-2fdf-fb37-e063-e6dba90a4e07	Children's All Day Allergy Sugar Free Grape

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55319-104-07	Childrens All Day Allergy Sugar Free Grape	118 mL in 1 BOTTLE	SUSPENSION	118	3
55319-104-07	Childrens All Day Allergy Sugar Free Grape	1 in 1 CARTON	SUSPENSION	1	3
55319-104-08	Childrens All Day Allergy Sugar Free Grape	1 in 1 CARTON	SUSPENSION	1	3
55319-104-08	Childrens All Day Allergy Sugar Free Grape	120 mL in 1 BOTTLE	SUSPENSION	120	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-104	CHILDRENS ALL DAY ALLERGY SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SUSPENSION [FAMILY WELLNESS]	3	Legacy NDC, 4 package rows	20241211_f932da65-6cfa-41d9-b522-ecd7c0217e1d.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 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
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
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
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
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
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
64O047KTOA	CETIRIZINE HYDROCHLORIDE	83881-52-1	CETIRIZINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-104-07	55319010407	1 BOTTLE in 1 CARTON (55319-104-07) > 118 mL in 1 BOTTLE	1 bottle	2019-10-03	0000-00-00	No	No	Current
55319-104-08	55319010408	1 BOTTLE in 1 CARTON (55319-104-08) > 120 mL in 1 BOTTLE	1 bottle	2018-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's All Day Allergy Sugar Free Grape	FAMILY WELLNESS \| Taro Pharmaceuticals Inc	2024-12-09	HUMAN OTC DRUG LABEL	3