Cetirizine Hydrochloride

Product NDC: 65162-003
11-digit product format: 651620003
Labeler code: 65162
Product ID: 65162-003_f9d002fa-9c05-4275-a783-053bf1993ca0
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine
Dosage form: SOLUTION
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA090765
Marketing category: ANDA
Marketing start: 2009-10-07
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2009-10-07
A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2009-10-07

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	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2009-10-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2009-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2009-10-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2009-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2009-10-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2009-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2009-10-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2009-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2009-10-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2009-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2009-10-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2009-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090765-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2009-10-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090765-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2009-10-07	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cetirizine Hydrochloride
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
7d16ccca-6aa3-4575-9fa7-f57301801a81	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-003-86	Cetirizine Hydrochloride	118 mL in 1 BOTTLE	SOLUTION	118		11
65162-003-86	Cetirizine Hydrochloride	1 in 1 CARTON	SOLUTION	1		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-003	CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS LLC]	11	Current NDC, Legacy NDC, 2 package rows	20241025_7d16ccca-6aa3-4575-9fa7-f57301801a81.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	e01f0db4-1b49-4b6e-b2fc-61834897bdd3	2024-10-23	Warnings	Exact identifier application applno (ANDA): 090765 application number: ANDA090765
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	7d16ccca-6aa3-4575-9fa7-f57301801a81	2024-10-23	Warnings	Exact identifier application applno (ANDA): 090765 application number: ANDA090765 ndc (product): 65162-003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
64O047KTOA	CETIRIZINE HYDROCHLORIDE	83881-52-1	CETIRIZINE HYDROCHLORIDE
YO7261ME24	CETIRIZINE	83881-51-0	Cetirizine

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	7d16ccca-6aa3-4575-9fa7-f57301801a81	11
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	7d16ccca-6aa3-4575-9fa7-f57301801a81	11
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	7d16ccca-6aa3-4575-9fa7-f57301801a81	11
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	7d16ccca-6aa3-4575-9fa7-f57301801a81	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-003-86	65162000386	1 BOTTLE in 1 CARTON (65162-003-86) / 118 mL in 1 BOTTLE	1 bottle	2009-10-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Oral Solution Antihistamine/ Hives Relief 1 mg/mL	Amneal Pharmaceuticals LLC	2024-10-23	HUMAN OTC DRUG LABEL	11