Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)

Product NDC: 25000-160
11-digit product format: 250000160
Labeler code: 25000
Product ID: 25000-160_cbb30ec0-aba7-4035-8f4a-a3e82b064857
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: MARKSANS PHARMA LIMITED
Application: ANDA078933
Marketing category: ANDA
Marketing start: 2025-04-10
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 1.

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
A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-06-15
A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-15
A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-06-15
A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-15

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1014676	Internal RxNorm lookup
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
652b0c65-a3f2-4454-9cf2-51a3389282cc	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
25000-160-03	Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)	1 in 1 CARTON	TABLET	1	13
25000-160-03	Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)	30 in 1 BOTTLE	TABLET	30	13
25000-160-14	Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)	1000 in 1 BOTTLE	TABLET	1000	13
25000-160-81	Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)	14 in 1 BLISTER PACK	TABLET	14	13
25000-160-81	Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)	1 in 1 CARTON	TABLET	1	13

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)	CETIRIZINE HYDROCHLORIDE	MARKSANS PHARMA LIMITED	652b0c65-a3f2-4454-9cf2-51a3389282cc	2026-07-10	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933 ndc (product): 25000-160
Cetirizine Hydrochloride Tablets,10 mg	CETIRIZINE HYDROCHLORIDE	Northwind Health Company, LLC	f756d3b1-d2e4-3705-e053-6294a90aa380	2026-01-01	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
ALLERGY	CETIRIZINE HYDROCHLORIDE	Kroger Company	bc020340-ef39-e49a-e053-2a95a90af810	2025-09-11	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Allergy Relief	CETIRIZINE HYDROCHLORIDE	BETTER LIVING BRANDS, LLC	eb60ae7d-87db-7413-e053-2a95a90afd76	2025-06-28	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Cetirizine Hydrochloride Tablets,10 mg	CETIRIZINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	d78223ba-80d5-47f8-e053-2a95a90aebdb	2024-03-06	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
All Day Allergy Relief	CETIRIZINE HYDROCHLORIDE	DOLGENCORP, INC.	0643ea78-9709-8526-e063-6394a90a227b	2023-12-15	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Allergy Relief	CETIRIZINE HYDROCHLORIDE	WALGREENS	f3c66f47-016a-799a-e053-2995a90ad424	2023-10-21	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	dfbddafb-9455-5805-e053-2a95a90ad0d9	2022-05-24	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933

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	652b0c65-a3f2-4454-9cf2-51a3389282cc	13
1014676	cetirizine HCl 5 MG Oral Tablet	PSN	652b0c65-a3f2-4454-9cf2-51a3389282cc	13
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	652b0c65-a3f2-4454-9cf2-51a3389282cc	13
1014676	cetirizine hydrochloride 5 MG Oral Tablet	SCD	652b0c65-a3f2-4454-9cf2-51a3389282cc	13
1014678	cetirizine HCl 10 MG Oral Tablet	SY	652b0c65-a3f2-4454-9cf2-51a3389282cc	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
25000-160-03	25000016003	1 BOTTLE in 1 CARTON (25000-160-03) / 30 TABLET in 1 BOTTLE	1 bottle	2025-04-10	No	No	Current
25000-160-14	25000016014	1000 TABLET in 1 BOTTLE (25000-160-14)	1000 tablet	2025-04-10	No	No	Current
25000-160-81	25000016081	1 BLISTER PACK in 1 CARTON (25000-160-81) / 14 TABLET in 1 BLISTER PACK	1 blister pack	2025-04-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allergy Relief Cetirizine Hydrochloride Tablets USP, 5 mg and 10 mg	MARKSANS PHARMA LIMITED	2026-07-10	Human OTC Drug Label	14