Cetirizine

Product NDC: 0904-7510
11-digit product format: 009047510
Labeler code: 0904
Product ID: 0904-7510_c5217eeb-1332-45da-8a5a-c9bf3d092327
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA078336
Marketing category: ANDA
Marketing start: 2025-04-07
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
A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27
A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A078336-004	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 · 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	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`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
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
71db132d-dca4-47ef-8560-c68ad2258933	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
0904-7510-61	Cetirizine	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		3
0904-7510-61	Cetirizine	100 in 1 CARTON	TABLET, FILM COATED	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7510-61	EA - Each	0904-7510	5ffe6eaf-5493-42bd-a06a-671ed0920e54	1	2025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7510	CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1	Current NDC, 2 package rows	20250410_71db132d-dca4-47ef-8560-c68ad2258933.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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
signature care allergy relief	CETIRIZINE HYDROCHLORIDE	Safeway	24099cbf-61ee-4ec8-a4ec-95a66ceaa0c0	2025-12-04	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
GOODNOW ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Gobrands, Inc	86ade508-8841-47d8-addb-418ecd6dc8de	2025-11-07	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	VERITYRX, LLC	43f40b92-f0e0-8808-e063-6394a90a656b	2025-10-30	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	88c3d23e-a0d8-4464-9414-666d74f11f66	2025-10-28	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
allergy relief	CETIRIZINE HYDROCHLORIDE	Safeway	c5e74b2c-7871-4f28-a77d-0d674b9b8c5e	2025-09-23	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Equaline all day allergy	CETIRIZINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	491fae66-83b6-4beb-945b-39b9e4e021c5	2025-09-18	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Good Sense all day allergy	CETIRIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc	0827643a-29b8-487a-a158-28976d672d4d	2025-09-12	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
CareOne Allergy Relief	CETIRIZINE HYDROCHLORIDE	American Sales Company	533abfc1-226e-4a68-bfcc-ec046a4d5751	2025-08-25	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
good neighbor pharmacy all day allergy	CETIRIZINE HYDROCHLORIDE	Amerisource Bergen	c568e388-60ab-47be-b362-7832b83d06ad	2025-07-21	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
leader all day allergy	CETIRIZINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	ce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf	2025-07-21	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
24 hour allergy	CETIRIZINE HYDROCHLORIDE	Meijer Distribution Inc	2b03c026-3e8a-4283-981f-965bc084c03d	2025-07-10	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
kirkland signature aller tec allergy	CETIRIZINE HYDROCHLORIDE	Costco Wholesale Company	d4a688aa-02d4-4af6-9a91-ed31679cfaf8	2025-06-10	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	ae93976d-de9b-43a6-b299-ce1f1ae8d6f8	2025-05-21	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	91fe3ab8-c155-4482-9f06-f029d3563aad	2025-03-06	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	25db4ca0-0c25-f3b6-e063-6394a90a8851	2024-11-01	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Members Mark Allergy Relief	CETIRIZINE HYDROCHLORIDE	Sam's West Inc	379756fd-f92d-4773-94fd-2682fcbdfba2	2024-05-10	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	af7513ae-5107-477c-a7da-0ded9d53a55c	2024-03-27	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Good Sense all day allergy	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	2f562a13-8909-4107-b135-10333707bab3	2024-01-24	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Good Sense all day allergy	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	c1a208c8-2554-4e8e-b506-aeb8e417d444	2024-01-24	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
betr remedies all day allergy relief	CETIRIZINE HYDROCHLORIDE	Live Betr LLC	4a017852-db01-4085-8947-d92a19ec4e5c	2023-05-10	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336

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	37c6d1e4-dd88-42a2-a828-539b68aa5dad	3
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	71db132d-dca4-47ef-8560-c68ad2258933	3
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	37c6d1e4-dd88-42a2-a828-539b68aa5dad	3
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	71db132d-dca4-47ef-8560-c68ad2258933	3
1014678	cetirizine HCl 10 MG Oral Tablet	SY	37c6d1e4-dd88-42a2-a828-539b68aa5dad	3
1014678	cetirizine HCl 10 MG Oral Tablet	SY	71db132d-dca4-47ef-8560-c68ad2258933	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7510-61	00904751061	100 BLISTER PACK in 1 CARTON (0904-7510-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2025-04-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals Cetirizine Drug Facts	Major Pharmaceuticals	2026-05-04	HUMAN OTC DRUG LABEL	3
Cetirizine Drug Facts	Cardinal Health 107, LLC	2026-04-16	HUMAN OTC DRUG LABEL	3