Cetirizine Hydrochloride (Allergy)

Product NDC: 68788-8204
Requested package NDC: 68788-8204-1
11-digit product format: 687888204
Labeler code: 68788
Product ID: 68788-8204_ec89e868-59e4-4bbd-8c95-5cf56f7df9ce
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA090760
Marketing category: ANDA
Marketing start: 2022-04-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`c2088c7a36db…`
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…`

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

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
1014678	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
73122009-531b-4929-bf57-494a6fc65b73	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	SPL version
68788-8204-0	Cetirizine Hydrochloride (Allergy)	100 in 1 BOTTLE	TABLET	100	4
68788-8204-1	Cetirizine Hydrochloride (Allergy)	14 in 1 BOTTLE	TABLET	14	4
68788-8204-3	Cetirizine Hydrochloride (Allergy)	30 in 1 BOTTLE	TABLET	30	4
68788-8204-5	Cetirizine Hydrochloride (Allergy)	15 in 1 BOTTLE	TABLET	15	4
68788-8204-6	Cetirizine Hydrochloride (Allergy)	60 in 1 BOTTLE	TABLET	60	4
68788-8204-9	Cetirizine Hydrochloride (Allergy)	90 in 1 BOTTLE	TABLET	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8204-0	EA - Each	68788-8204	50eeece5-1af1-4965-b4f4-6c26673e0ed5	1	2023-06-06
68788-8204-1	EA - Each	68788-8204	533cd032-fec4-4ca4-be12-f67c225e9d51	1	2023-06-06
68788-8204-3	EA - Each	68788-8204	5fdad5bc-978c-48c4-878d-17d6441577f2	1	2023-06-06
68788-8204-5	EA - Each	68788-8204	bbe538f2-665d-4adf-bc0c-918569c4f11b	1	2023-06-06
68788-8204-6	EA - Each	68788-8204	d9760758-83c3-4059-a2d8-f83db7896c44	1	2023-06-06
68788-8204-9	EA - Each	68788-8204	fdbe6f78-5b39-45ad-98b1-e9e6256b380d	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8204	CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [PREFERRED PHARMACEUTICALS INC.]	2	Current NDC, 6 package rows	20240912_73122009-531b-4929-bf57-494a6fc65b73.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 · 15 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 ndc (package): 68788-8204-1 ndc (product): 68788-8204 ndc11 (package): 68788820401
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	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	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	73122009-531b-4929-bf57-494a6fc65b73	4
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	73122009-531b-4929-bf57-494a6fc65b73	4
1014678	cetirizine HCl 10 MG Oral Tablet	SY	73122009-531b-4929-bf57-494a6fc65b73	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8204-1	68788820401	14 TABLET in 1 BOTTLE (68788-8204-1)	14 tablet	2022-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride (Allergy) - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2026-03-25	HUMAN OTC DRUG LABEL	4