Cetirizine Hydrochloride

Product NDC: 53329-652
11-digit product format: 533290652
Labeler code: 53329
Product ID: 53329-652_efd12ec8-8f3d-c1e3-e053-2995a90a685a
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Medline Industries, LP
Application: ANDA077498
Marketing category: ANDA
Marketing start: 2007-12-27
Marketing end: 0000-00-00
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53329-652		D	Discontinued by firm		2026-10-05
excluded package	package	53329-652	53329-652-38	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27
A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27

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 5 · 172 observed 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	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-652	CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, LP]	7	Legacy NDC	20221217_6823d475-84c6-4d9f-838d-925ccfb96c97.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sportpharm LLC	357523b6-618b-4bff-a80d-c62e72a0804e	2026-05-08	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a7da81e1-8865-45c9-83c7-32fb8032ca2e	2026-03-19	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc	eb917099-fecf-6b55-e053-2995a90aaafa	2025-09-23	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	d0d8b376-9001-8776-e053-2a95a90ae651	2024-08-12	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	15eaa0d1-d18d-72b1-e063-6394a90a8a94	2024-04-12	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	d14feb90-3ca2-4d5b-825c-25fc2252ca38	2022-06-01	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Ohm Laboratories Inc.	161c4122-2c89-46e6-a6ae-db088087330d	2021-05-21	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	a0a063a1-e067-480e-afab-7f01165025f4	2019-08-19	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Chain Drug Consortium, LLC	9d7d2342-a594-4851-810b-b7bce1bd07dc	2018-08-24	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Valu Merchandisers Company	4a8d2887-8ac3-4d54-9e67-4a271d416426	2018-08-23	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Quality Choice Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Chain Drug Marketing Association Inc.	2e8cc4e3-8386-42de-801f-fef37f612849	2018-08-22	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Marc Glassman, Inc.	f30900e6-425f-43e0-81b6-1fa3bd321f0b	2018-06-20	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	LIDL US, LLC	a210d6b7-0829-4120-bb6d-fee0c2e57b26	2018-01-09	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	FAMILY DOLLAR SERVICES, INC	b326dacc-6123-47a7-9fde-6909db1d780b	2018-01-08	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498

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
53329-652-38	53329065238	90 TABLET in 1 BOTTLE (53329-652-38)	90 tablet	2007-12-27	0000-00-00	No	No	Current