Childrens Cetirizine Hydrochloride Hives Relief

Product NDC: 65862-443
11-digit product format: 658620443
Labeler code: 65862
Product ID: 65862-443_2474de7e-aff1-473e-9adf-8ec07b5a3dc1
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA090750
Marketing category: ANDA
Marketing start: 2010-02-02
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65862-443		D	Discontinued by firm	2026-08-17
excluded package	package	65862-443	65862-443-12	D	Discontinued by firm	2026-08-17
excluded package	package	65862-443	65862-443-24	D	Discontinued by firm	2026-08-17
excluded package	package	65862-443	65862-443-48	D	Discontinued by firm	2026-08-17

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 · 48 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	65862-443-48	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65862-443-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65862-443-24	`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	65862-443-48	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65862-443-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65862-443-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-443-48	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-443-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-443-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-443-48	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-443-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-443-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-443-48	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-443-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-443-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-443-48	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-443-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-443-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-443-48	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-443-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-443-24	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-443-48	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-443-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-443-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65862-443-48	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65862-443-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65862-443-24	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65862-443-48	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65862-443-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65862-443-24	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65862-443-48	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65862-443-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65862-443-24	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65862-443-48	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65862-443-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65862-443-24	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2010-02-02
A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2010-02-02

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`bb7c543d1eb4…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]	2
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]	2
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]	2
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROBINDO PHARMA LIMITED]	2

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy Relief	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	52dc28ac-4059-4b6c-8bbc-22aa479a549a	2026-03-09	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750
Childrens Cetirizine Hydrochloride Allergy	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	4de4f544-79cd-4a89-aafb-f2e2688b3c81	2026-03-09	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750
Childrens Cetirizine Hydrochloride Hives Relief	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	bd489217-bf7c-429b-a58c-426104f7e779	2025-12-16	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750
Childrens Cetirizine Hydrochloride Hives Relief	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	e000848a-8bbe-4149-bdcb-d7b4b0bd4d0d	2025-12-09	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Fred's, Inc.	55e799b2-e325-4286-aa9a-b88e99ab1146	2020-12-13	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	C.D.M.A., Inc.	b4feed95-86ca-411c-99b5-773e485e752f	2020-12-13	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Childrens Cetirizine Hydrochloride Hives Relief - Aurobindo Pharma Limited	Aurobindo Pharma Limited	2019-10-30	Human OTC Drug Label	3