Cetirizine Hydrochloride

Product NDC: 71205-164
11-digit product format: 712050164
Labeler code: 71205
Product ID: 71205-164_0df97f57-2593-49af-83ca-138de55289c8
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077829
Marketing category: ANDA
Marketing start: 2009-10-01
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2009-08-26
A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RS	2009-08-26
A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2009-08-26
A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2009-08-26

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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cetirizine Hydrochloride
Listing expiration: 2026-12-31

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
0b116de8-55c5-44dc-b0b6-f5a919e39a65	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
71205-164-15	Cetirizine Hydrochloride	15 in 1 BOTTLE	TABLET	15	2
71205-164-30	Cetirizine Hydrochloride	30 in 1 BOTTLE	TABLET	30	2
71205-164-60	Cetirizine Hydrochloride	60 in 1 BOTTLE	TABLET	60	2
71205-164-90	Cetirizine Hydrochloride	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-164-30	EA - Each	71205-164	cde64369-ae8c-4c65-ae84-e8a0f2766487	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-164	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	2	Current NDC, Legacy NDC, 4 package rows	20191016_0b116de8-55c5-44dc-b0b6-f5a919e39a65.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4913192a-7364-3f19-e054-00144ff8d46c	2026-08-20	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	f2f42f36-6b09-4140-e053-2a95a90af813	2026-06-29	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Goodmeds All Day Allergy Relief Cetirizine HCl	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	cd13a70e-b9e2-41be-97ea-f022442b6460	2026-04-08	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	Pioneer Life Sciences, LLC	5249b83c-30d4-4b5b-aeb1-f52418ba079f	2026-04-06	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Indoor and Outdoor Allergy Relief	CETIRIZINE HCL	Famora Inc.	2a94d25c-aacf-4f5c-b406-815f0e1d0611	2026-03-18	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sportpharm LLC	dd50d2e9-3de7-4c44-96ed-39ef04dae702	2026-02-06	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Strategic Sourcing Services LLC	54509525-ad99-4165-a571-47ece058e292	2026-01-29	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Prodose, Inc	e0e5f482-0282-410c-8c40-0a33ca4ea23a	2026-01-26	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	Pioneer Life Sciences, LLC	205b42e0-9d02-4755-9ee6-5883147abeb3	2025-12-23	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	Pioneer Life Sciences, LLC	b275feae-56a1-4a60-a564-8d7b18c06aa2	2025-12-23	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	NUVICARE LLC	c728edf3-e6b5-4860-b966-39cf3ee4ff77	2025-12-19	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
RIGHT REMEDIES ALL-DAY Allergy Relief	CETIRIZINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	8227edbe-88d5-4d79-9175-891dd9566357	2025-11-20	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	5481ccb3-b311-4b25-b923-4fe8522ea92b	2025-11-05	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
ValuMeds All Day Allergy Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	3071238a-6b35-4da8-8305-eced56c513ce	2025-10-23	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
CVS Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy	3d711302-dc4e-0a69-e063-6394a90ade10	2025-09-18	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cabinet Allergy Relief Refill Cetirizine HCI	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	0eaf9d27-e221-4cdd-97bc-478c775e3d67	2025-07-03	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Allergy Relief	CETIRIZINE HCL	NUVICARE LLC	09dfdce2-7184-4247-983c-a5667e4a9da1	2025-06-09	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
ALLERGY RELIEF	CETIRIZINE HCL	Pioneer Life Sciences, LLC	110adf3c-84ce-48a1-8a22-89ee3eec22d9	2025-06-01	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cabinet All Day Allergy Relief	CETIRIZINE HYDROCHLORIDE	Cabinet Health P.B.C.	889316bc-5f98-426a-9750-2fdb0c427408	2025-04-07	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Umasuto, LLC	9af4ab23-d6d3-43f9-a026-76fd9771963f	2025-03-06	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829

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	0b116de8-55c5-44dc-b0b6-f5a919e39a65	2
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	0b116de8-55c5-44dc-b0b6-f5a919e39a65	2
1014678	cetirizine HCl 10 MG Oral Tablet	SY	0b116de8-55c5-44dc-b0b6-f5a919e39a65	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-164-15	71205016415	15 TABLET in 1 BOTTLE (71205-164-15)	15 tablet	2018-12-01	0000-00-00	No	No	Current
71205-164-30	71205016430	30 TABLET in 1 BOTTLE (71205-164-30)	30 tablet	2018-12-01	0000-00-00	No	No	Current
71205-164-60	71205016460	60 TABLET in 1 BOTTLE (71205-164-60)	60 tablet	2018-12-01	0000-00-00	No	No	Current
71205-164-90	71205016490	90 TABLET in 1 BOTTLE (71205-164-90)	90 tablet	2018-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy	Proficient Rx LP	2019-10-01	HUMAN OTC DRUG LABEL	2