Cetirizine Hydrochloride

Product NDC: 76162-009
11-digit product format: 761620009
Labeler code: 76162
Product ID: 76162-009_7baa79c5-be46-4b09-8cae-c306edb7f97a
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: TOPCO ASSOCIATES LLC
Application: ANDA213557
Marketing category: ANDA
Marketing start: 2024-06-06
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
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 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
A213557-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2020-09-11

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.

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	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213557-001	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-11	`a50c72e98297…`

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: Cetirizine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	10 mg/1

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
1011482	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
f4ba3e0c-e6b3-2596-e053-2a95a90ab850	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	Strength	SPL version
76162-009-76	Cetirizine Hydrochloride	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6		2
76162-009-76	Cetirizine Hydrochloride	4 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	4		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76162-009	CETIRIZINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [TOPCO ASSOCIATES LLC]	2	Current NDC, 2 package rows	20240612_f4ba3e0c-e6b3-2596-e053-2a95a90ab850.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	17e93c22-1ff7-4af9-bd5a-448836aec65f	2026-08-25	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	cd895177-3c25-4a1b-81a0-b85f4877787a	2026-08-25	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy, Inc.	b45c95f2-91c9-55b5-e053-2995a90a75b7	2026-05-04	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy, Inc.	b955c7ed-29da-959f-e053-2a95a90a03d4	2026-05-04	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557
CHILDRENS CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	WALMART INC.	473ad691-2499-a706-e063-6394a90a9781	2026-01-30	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	WALGREEN CO.	9e728bf2-0cb9-ecf5-e053-2a95a90a408a	2026-01-08	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	f4ba3e0c-e6b3-2596-e053-2a95a90ab850	2024-06-11	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557 ndc (product): 76162-009
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	WALGREEN CO.	a9fd9b8f-509b-1ffa-e053-2a95a90a6d0f	2024-04-15	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	KROGER COMPANY	b8b2af96-af48-5f63-e053-2995a90a7d7c	2021-05-06	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	c111f6f3-e190-447f-b4a4-e277af641483	2021-05-06	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	d9ebebb5-736a-4019-8c1a-030148de9d02	2021-05-06	Warnings	Exact identifier application applno (ANDA): 213557 application number: ANDA213557

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
1011482	cetirizine HCl 10 MG Disintegrating Oral Tablet	PSN	f4ba3e0c-e6b3-2596-e053-2a95a90ab850	2
1011482	cetirizine hydrochloride 10 MG Disintegrating Oral Tablet	SCD	f4ba3e0c-e6b3-2596-e053-2a95a90ab850	2
1011482	cetirizine HCl 10 MG Disintegrating Oral Tablet	SY	f4ba3e0c-e6b3-2596-e053-2a95a90ab850	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76162-009-76	76162000976	4 BLISTER PACK in 1 CARTON (76162-009-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	4 blister pack	2024-06-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CETIRIZINE - TOPCO ASSOCIATES LLC \| Aurohealth LLC \| APL HEALTHCARE LIMITED	TOPCO ASSOCIATES LLC \| Aurohealth LLC \| APL HEALTHCARE LIMITED	2024-06-11	Human OTC Drug Label	2