Cetirizine Hydrochloride (Allergy)

Product NDC: 58602-823
Requested package NDC: 58602-823-19
11-digit product format: 586020823
Labeler code: 58602
Product ID: 58602-823_674393cc-4e62-4340-a72b-87d3cb81613c
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA090760
Marketing category: ANDA
Marketing start: 2015-08-05
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: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58602-823	58602-823-19	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-08-05
A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-08-05
A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-08-05
A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-08-05

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	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`5bbf6a4d5a75…`

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 (Allergy)
Listing expiration: 2027-12-31

Active Ingredients#

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

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	SPL version
58602-823-09	Cetirizine Hydrochloride (Allergy)	30 in 1 BOTTLE	TABLET	30	4
58602-823-09	Cetirizine Hydrochloride (Allergy)	1 in 1 CARTON	TABLET	1	4
58602-823-19	Cetirizine Hydrochloride (Allergy)	1 in 1 CARTON	TABLET	1	4
58602-823-19	Cetirizine Hydrochloride (Allergy)	90 in 1 BOTTLE	TABLET	90	4
58602-823-39	Cetirizine Hydrochloride (Allergy)	365 in 1 BOTTLE	TABLET	365	4
58602-823-39	Cetirizine Hydrochloride (Allergy)	1 in 1 CARTON	TABLET	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-823	CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]	4	Current NDC, Legacy NDC, 6 package rows	20240120_7d214cba-951d-464e-b37e-e83098944fe6.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Better Living Brands, LLC	f7e16d96-4f23-cbca-e053-6394a90aef4e	2026-08-24	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25	2026-08-03	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Hives Relief)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a	2026-08-03	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	KROGER COMPANY	b92d959d-dd35-b2a3-e053-2995a90af3ff	2026-07-15	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	c1ae7bb1-e154-4745-b01e-bc91d50d35c8	2026-05-25	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	73122009-531b-4929-bf57-494a6fc65b73	2026-03-25	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	ae02b16b-77dc-4bd6-8c07-e734fb448492	2026-01-29	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	158d3bcc-6a7f-4ee7-b181-be3fd6f94f8d	2026-01-29	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	BluePoint Laboratories	a86fbe45-08db-bddf-e053-2a95a90aa792	2025-10-30	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE ALLERGY	LEADER/ CARDINAL HEALTH 110, INC.	0cab7aa8-ded3-46f1-b801-2663cc9b0173	2025-10-03	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	INNOVUS PHARMACEUTICALS, INC.	89db2c96-62f6-4e75-8f0d-321b44094c60	2025-04-28	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	42c9636f-07af-44a3-8d84-c11e1b57783a	2024-07-02	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	NorthStar Rx LLC	c9d1e26f-c95a-4991-95fa-9ed6ed484fe2	2024-06-26	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
AMAZON BASIC CARE ALL DAY ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	113e66f1-b922-8533-e063-6294a90ab30e	2024-05-10	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy, Inc.	e340cd4b-5413-42c6-a956-eb15c3807aeb	2024-03-29	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	d69083c4-b028-453c-8235-560b40ad358b	2024-03-01	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	7d214cba-951d-464e-b37e-e83098944fe6	2024-01-11	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760 ndc (package): 58602-823-19 ndc (product): 58602-823 ndc11 (package): 58602082319
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	WALGREEN CO.	c0165b0e-d5e9-a028-e053-2a95a90ab431	2023-05-25	Warnings	Exact identifier application applno (ANDA): 090760 application number: ANDA090760

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
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	7d214cba-951d-464e-b37e-e83098944fe6	4
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	7d214cba-951d-464e-b37e-e83098944fe6	4
1014678	cetirizine HCl 10 MG Oral Tablet	SY	7d214cba-951d-464e-b37e-e83098944fe6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-823-19	58602082319	1 BOTTLE in 1 CARTON (58602-823-19) > 90 TABLET in 1 BOTTLE	1 bottle	2015-08-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Tablets USP 10 mg	Aurohealth LLC \| APL HEALTHCARE LIMITED \| Aurobindo Pharma Limited	2026-09-25	Human OTC Drug Label	5