Cetirizine Hydrochloride

Product NDC: 65162-145
11-digit product format: 651620145
Labeler code: 65162
Product ID: 65162-145_2231625e-ba4f-4106-81ed-12137d0464a6
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA078780
Marketing category: ANDA
Marketing start: 2010-01-21
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 5 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65162-145-50	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65162-145-03	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65162-145-50	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65162-145-03	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65162-145-50	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65162-145-03	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65162-145-50	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65162-145-03	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65162-145-50	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65162-145-03	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	65162-145-50	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	65162-145-03	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65162-145-50	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65162-145-03	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	Approval date
A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-01-21
A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-01-21
A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-01-21
A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-01-21

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`d8e5a09893c0…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	5 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
1014676	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
aad39214-5bf1-427b-a00e-410224c51c95	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
65162-145-03	2023-08-17	CETIRIZINE HYDROCHLORIDE TABLETS
65162-145-50	2023-08-17	CETIRIZINE HYDROCHLORIDE TABLETS
65162-145-03	2020-01-31	CETIRIZINE HYDROCHLORIDE TABLETS
65162-145-50	2020-01-31	CETIRIZINE HYDROCHLORIDE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-145-03	Cetirizine HydrochlorideHives Relief	1 in 1 CARTON	TABLET	1	7
65162-145-03	Cetirizine HydrochlorideHives Relief	30 in 1 BOTTLE	TABLET	30	7
65162-145-50	Cetirizine HydrochlorideHives Relief	500 in 1 BOTTLE	TABLET	500	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS]	5
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS]	5
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-145	CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS LLC]	7	Current NDC, Legacy NDC, 3 package rows	20241025_aad39214-5bf1-427b-a00e-410224c51c95.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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
All Day Allergy Relief	CETIRIZINE HCL	P & L Development, LLC	a042d98d-35ad-4d40-8b27-79dafd028096	2025-08-18	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780
Allergy Relief All Day	CETIRIZINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	27548729-7e2e-44cd-9a1d-70744f8b1df6	2025-07-01	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780
Cetirizine Hydrochloride Hives Relief	CETIRIZINE	Amneal Pharmaceuticals LLC	aad39214-5bf1-427b-a00e-410224c51c95	2024-10-23	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780 ndc (product): 65162-145
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	214936a2-adc4-422a-a8fe-4c3ce9e01f36	2024-07-31	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	273172b2-9aaf-46fb-a1ce-2961650eacd3	2024-07-31	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
64O047KTOA	CETIRIZINE HYDROCHLORIDE	83881-52-1	CETIRIZINE HYDROCHLORIDE
YO7261ME24	CETIRIZINE	83881-51-0	Cetirizine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1014676	cetirizine HCl 5 MG Oral Tablet	PSN	aad39214-5bf1-427b-a00e-410224c51c95	7
1014676	cetirizine hydrochloride 5 MG Oral Tablet	SCD	aad39214-5bf1-427b-a00e-410224c51c95	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
65162-145-03	65162014503	1 BOTTLE in 1 CARTON (65162-145-03) / 30 TABLET in 1 BOTTLE	1 bottle	2010-01-21	No	No	Current
65162-145-50	65162014550	500 TABLET in 1 BOTTLE (65162-145-50)	500 tablet	2010-01-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CETIRIZINE HYDROCHLORIDE TABLETS	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2024-10-23	HUMAN OTC DRUG LABEL	7