Cetirizine hydrochloride

Product NDC: 37835-611
11-digit product format: 378350611
Labeler code: 37835
Product ID: 37835-611_36d0b7f3-2156-873a-e063-6294a90ac015
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bi-Mar
Application: ANDA209274
Marketing category: ANDA
Marketing start: 2025-05-01
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL			2017-12-22

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 2 · 41 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	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209274-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2017-12-22	`cb3db0bc1861…`

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
cbb270c3-34a4-4af8-9da0-2e545787cb55	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
37835-611-14	Cetirizine hydrochloride	14 in 1 BOTTLE	TABLET	14	1
37835-611-35	Cetirizine hydrochloride	35 in 1 BOTTLE	TABLET	35	1
37835-611-90	Cetirizine hydrochloride	90 in 1 BOTTLE	TABLET	90	1

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 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine hydrochloride - HIVES	CETIRIZINE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	562b5e6c-6103-df3d-e063-6394a90a897d	2026-07-14	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Granules India Ltd	6efd5a60-e281-43f9-a52c-a95f46fbcbfc	2026-07-14	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Medline	CETIRIZINE HCL	Medline Industries, LP	a75cd557-e19b-fdd4-e053-2a95a90a8097	2026-06-04	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	AAA PHARMACEUTICAL, INC.	ac22558b-5c82-4ab9-95b8-53eedea46282	2026-05-28	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	Grocery Outlet, Inc	441d049c-8844-955e-e063-6294a90a666d	2026-05-21	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	TWIN MED, LLC	14317ee7-1061-4c2b-9427-3433e27f13f5	2026-04-01	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL	Bryant Ranch Prepack	7e4a2d02-c2b3-4a1f-8373-a0b0dec5ddea	2026-03-10	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
All Day Allergy Relief	CETIRIZINE HCL	P & L Development, LLC	c5dab2f3-8f95-4b85-995b-23b21c762ae8	2026-02-23	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
All Day Allergy Relief	CETIRIZINE HCL	Strategic Sourcing Services LLC	2965303e-bedc-41fb-af97-827c30575091	2026-01-05	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Granules USA, Inc.	c8d711cd-7214-c7d5-e053-2995a90a6b67	2025-12-22	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES,LLC.	9f04520e-161d-3f7b-e053-2a95a90a678d	2025-12-19	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine HCL	CETIRIZINE HCL	Meijer	181c63dd-6ab8-909a-e063-6394a90af141	2025-12-19	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine	CETIIRIZINE	CVS PHARMACY, INC	fd8f495a-9940-363b-e053-6294a90a1097	2025-12-19	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	SAFEWAY	ed0eecfb-85bf-63bf-e053-2995a90a0e03	2025-12-18	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	dc66bf53-820f-40a3-b5ef-c653dd375544	2025-12-11	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	d55dfce1-acef-3342-e053-2a95a90a4b83	2025-12-04	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
CAREALL Allergy Relief	CETIRIZINE HCL	New World Imports	d3411eec-05b1-49b3-86e8-bc47ac0ef6b7	2025-12-01	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Allergy Relief	CETIRIZINE HCL	Family Dollar (FAMILY WELLNESS)	b90b5ef2-5aa2-45ca-94b9-c9d9e5877e23	2025-09-25	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Wal-Zyr	CETIRIZINE HCL	Walgreens	f0d3f681-92c4-45d4-9533-656c9e5e2366	2025-07-02	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Advanced Rx LLC	737492bf-96bd-4f7c-aa42-4910746f44bb	2025-05-13	Warnings	Exact identifier application applno (ANDA): 209274 application number: ANDA209274

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	cbb270c3-34a4-4af8-9da0-2e545787cb55	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	cbb270c3-34a4-4af8-9da0-2e545787cb55	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	cbb270c3-34a4-4af8-9da0-2e545787cb55	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
37835-611-14	37835061114	14 TABLET in 1 BOTTLE (37835-611-14)	14 tablet	2025-05-01	No	No	Current
37835-611-35	37835061135	35 TABLET in 1 BOTTLE (37835-611-35)	35 tablet	2025-05-01	No	No	Current
37835-611-90	37835061190	90 TABLET in 1 BOTTLE (37835-611-90)	90 tablet	2025-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine hydrochloride - Bi-Mar \| Granules India Ltd	Bi-Mar \| Granules India Ltd	2025-05-01	HUMAN OTC DRUG LABEL	1