cetirizine hydrochloride

Product NDC: 71205-207
11-digit product format: 712050207
Labeler code: 71205
Product ID: 71205-207_517ed467-a0d0-43ab-99ce-e6a4808800c4
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA078336
Marketing category: ANDA
Marketing start: 2007-12-27
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
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 · 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	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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`

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
198ca875-bb8a-49d5-8809-7121ba119381	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
71205-207-06	cetirizine hydrochloride	6 in 1 BOTTLE	TABLET	6	8
71205-207-10	cetirizine hydrochloride	10 in 1 BOTTLE	TABLET	10	8
71205-207-15	cetirizine hydrochloride	15 in 1 BOTTLE	TABLET	15	8
71205-207-30	cetirizine hydrochloride	30 in 1 BOTTLE	TABLET	30	8
71205-207-60	cetirizine hydrochloride	60 in 1 BOTTLE	TABLET	60	8
71205-207-90	cetirizine hydrochloride	90 in 1 BOTTLE	TABLET	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-207-06	EA - Each	71205-207	48e3d9bc-69ef-4216-9457-349048e46614	1	2019-11-12
71205-207-10	EA - Each	71205-207	6a23f314-7e7b-4967-ab35-4f4153fd9dcb	1	2019-10-07
71205-207-15	EA - Each	71205-207	7df610f0-7245-4b67-a2bc-cfb155cc687b	1	2019-11-12
71205-207-30	EA - Each	71205-207	b99fdaf2-f2f0-4f23-99bd-d6f1f65c8ded	1	2019-04-11
71205-207-90	EA - Each	71205-207	61bff00e-2867-4f39-959c-753382b8828e	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-207	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	8	Current NDC, Legacy NDC, 6 package rows	20220409_198ca875-bb8a-49d5-8809-7121ba119381.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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health all day allergy	CETIRIZINE HYDROCHLORIDE	Dolgencorp Inc	b9ac489a-80ed-4077-b68e-d03df1b892a6	2026-07-28	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
allergy relief	CETIRIZINE HYDROCHLORIDE	H E B	8649fc1e-ad56-4660-bbbb-8f1ed795697b	2026-07-20	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Major Pharmaceuticals	71db132d-dca4-47ef-8560-c68ad2258933	2026-05-04	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
All Day Allergy	CETIRIZINE HYDROCHLORIDE	HyVee Inc	8889af37-8345-4358-994d-7d8b847f4874	2026-04-22	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Cardinal Health 107, LLC	37c6d1e4-dd88-42a2-a828-539b68aa5dad	2026-04-16	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Allergy Relief Indoor and Outdoor Allergies	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy	98f3f2c6-da18-4055-81f1-962261360f9b	2026-03-31	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	7e158fd6-268d-4ffc-a410-d054090d54c5	2026-03-19	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
BERKLEY AND JENSEN ALL DAY ALLERGY	CETIRIZINE HYDROCHLORIDE	BJWC	b38c0068-5b06-4976-b68d-617bcc14f051	2026-02-11	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Major Pharmaceuticals	a5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a3	2026-01-29	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a462f9c0-45ef-49b1-b0d8-a02a75a4b731	2026-01-27	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Exchange select all day allergy	CETIRIZINE HYDROCHLORIDE	Army & Air Force Exchange Service	e7220494-3640-4b33-b577-ed3ca7c483e8	2026-01-15	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Good Sense all day allergy	CETIRIZINE HYDROCHLORIDE	L. Perrigo Company	2a7a27ab-1b4c-40d1-98bf-e4297aa25682	2026-01-08	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Northwind Health Company, LLC	f2b4d221-30ae-5a43-e053-2995a90a238a	2026-01-01	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
TopCare All Day Allergy	CETIRIZINE HYDROCHLORIDE	Topco Associates LLC	f2919aad-9ed4-40b8-b233-4aec06df33ea	2025-12-23	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Up and Up Allergy Relief	CETIRIZINE HYDROCHLORIDE	Target Corporation	ce93ca5b-2a65-4873-9686-926c44076c6c	2025-12-19	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	ff782956-03b7-4ae6-b78f-fb7fe78b262d	2025-12-05	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4a45672b-67d3-4739-86ec-0a6696dd83d4	2025-12-04	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
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

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	198ca875-bb8a-49d5-8809-7121ba119381	8
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	198ca875-bb8a-49d5-8809-7121ba119381	8
1014678	cetirizine HCl 10 MG Oral Tablet	SY	198ca875-bb8a-49d5-8809-7121ba119381	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-207-06	71205020706	6 TABLET in 1 BOTTLE (71205-207-06)	6 tablet	2019-09-01	0000-00-00	No	No	Current
71205-207-10	71205020710	10 TABLET in 1 BOTTLE (71205-207-10)	10 tablet	2019-08-01	0000-00-00	No	No	Current
71205-207-15	71205020715	15 TABLET in 1 BOTTLE (71205-207-15)	15 tablet	2019-10-01	0000-00-00	No	No	Current
71205-207-30	71205020730	30 TABLET in 1 BOTTLE (71205-207-30)	30 tablet	2019-01-01	0000-00-00	No	No	Current
71205-207-60	71205020760	60 TABLET in 1 BOTTLE (71205-207-60)	60 tablet	2019-01-01	0000-00-00	No	No	Current
71205-207-90	71205020790	90 TABLET in 1 BOTTLE (71205-207-90)	90 tablet	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Cetirizine Hydrochloride Tablets 10 mg Drug Facts	Proficient Rx LP	2022-04-01	HUMAN OTC DRUG LABEL	8