Cetirizine HCl

Product NDC: 80136-856
Requested package NDC: 80136-856-23
11-digit product format: 801360856
Labeler code: 80136
Product ID: 80136-856_0647ef67-e7f9-a73e-e063-6294a90abe76
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: Northeast Pharma
Application: NDA022429
Marketing category: NDA
Marketing start: 2023-09-26
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	RLD / RS	Approval date
N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	RLD	2009-07-23
N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23
N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	RLD	2009-07-23
N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cetirizine HCl
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
1014675	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
0647ef4c-8912-9f44-e063-6294a90ae3a6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80136-856-23	Cetirizine HCl	25 in 1 BOTTLE, PLASTIC	CAPSULE	25		1
80136-856-23	Cetirizine HCl	1 in 1 CARTON	CAPSULE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80136-856	CETIRIZINE HCL CAPSULE [NORTHEAST PHARMA]	1	Current NDC, 2 package rows	20230928_0647ef4c-8912-9f44-e063-6294a90ae3a6.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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE HCL	Whole Foods Market, INC.	453b20b5-72a7-ac09-e063-6394a90afc4b	2026-06-22	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	PUBLIX SUPER MARKETS INC	4d652305-67f3-33f3-e063-6294a90a367e	2026-06-22	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	AMERISOURCE BERGEN	518ed897-7365-0520-e063-6394a90a06d6	2026-05-11	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	TOP CARE (Topco Associates LLC)	3363bd32-cac6-e10c-e063-6294a90a2638	2026-05-11	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Meijer Distribution Inc	3143de16-2006-ec2e-e063-6294a90a1f67	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	WALGREEN COMPANY	4a181a38-ac94-8d00-e063-6394a90a6bf6	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Bionpharma Inc.	4fe8f764-a8e2-a432-e063-6294a90a33b0	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	TARGET Corporation	363845a9-c379-16a7-e063-6394a90a011a	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	KROGER COMPANY	33f181f8-6e0d-b89b-e063-6394a90aeae7	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Bionpharma Inc.	2c2c4828-0479-4ff3-b2b0-dde5fa74efaf	2025-12-16	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	TARGET Corporation	e39a1a4f-c786-479a-9c11-aaf591810fe7	2025-12-16	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	KROGER COMPANY	63ddeea4-d701-42b2-bcb7-81c0e43eb013	2025-11-24	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Meijer Distribution Inc	235bf16e-4c23-95f8-e063-6394a90a62d5	2024-11-25	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	DOLGENCORP INC	235c2640-8d6a-249d-e063-6394a90a132a	2024-11-25	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	TOP CARE (Topco Associates LLC)	2033e2c3-81af-b1cf-e063-6394a90adbc5	2024-11-22	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	PUBLIX SUPER MARKETS INC	1ab5c526-b5fd-fca0-e063-6294a90ac54a	2024-10-03	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
24 HOUR ALLERGY	CETIRIZINE HCL	Walgreens	f3168f2c-27a7-4dd7-9770-e91443a580f1	2024-04-01	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Northeast Pharma	0647ef4c-8912-9f44-e063-6294a90ae3a6	2023-09-26	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429 ndc (package): 80136-856-23 ndc (product): 80136-856 ndc11 (package): 80136085623
All Day Allergy Relief	CETIRIZINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC.	ec81dc4c-74c0-4719-be5d-686d545f4003	2022-12-29	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Allergy Relief	CETIRIZINE HCL	DISCOUNT DRUG MART, INC.	89c77f0d-a325-4f8f-9142-98c0d41de8b1	2022-12-29	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429

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
1014675	cetirizine HCl 10 MG 24HR Oral Capsule	PSN	0647ef4c-8912-9f44-e063-6294a90ae3a6	1
1014675	cetirizine hydrochloride 10 MG Oral Capsule	SCD	0647ef4c-8912-9f44-e063-6294a90ae3a6	1
1014675	cetirizine HCl 10 MG 24 HR Oral Capsule	SY	0647ef4c-8912-9f44-e063-6294a90ae3a6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80136-856-23	80136085623	1 BOTTLE, PLASTIC in 1 CARTON (80136-856-23) / 25 CAPSULE in 1 BOTTLE, PLASTIC	2023-09-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine HCl Capsules, 10 mg	Northeast Pharma \| Bionpharma Inc. \| Patheon Softgels Inc.	2023-09-26	HUMAN OTC DRUG LABEL	1