Cetirizine HCl

Product NDC: 69452-479
Requested package NDC: 69452-479-88
11-digit product format: 694520479
Labeler code: 69452
Product ID: 69452-479_4fe8f1cd-8262-e908-e063-6394a90a1173
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: Bionpharma Inc.
Application: NDA022429
Marketing category: NDA
Marketing start: 2026-05-25
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: 2027-12-31
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 69452-479-88 ndc (product): 69452-479 ndc11 (package): 69452047988
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
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

Additional Listing Data#

Finished product: Yes
Brand name base: Cetirizine HCl
Listing expiration: 2027-12-31

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
4fe8f764-a8e2-a432-e063-6294a90a33b0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
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
69452-479-88	Cetirizine HCl	65 in 1 BOTTLE, PLASTIC	CAPSULE	65		1
69452-479-88	Cetirizine HCl	1 in 1 CARTON	CAPSULE	1		1

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	4fe8f764-a8e2-a432-e063-6294a90a33b0	1
1014675	cetirizine hydrochloride 10 MG Oral Capsule	SCD	4fe8f764-a8e2-a432-e063-6294a90a33b0	1
1014675	cetirizine HCl 10 MG 24 HR Oral Capsule	SY	4fe8f764-a8e2-a432-e063-6294a90a33b0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69452-479-88	69452047988	1 BOTTLE, PLASTIC in 1 CARTON (69452-479-88) / 65 CAPSULE in 1 BOTTLE, PLASTIC	2026-05-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine HCl Capsules, 10 mg dye free-a+health	Bionpharma Inc. \| Patheon Softgels Inc.	2026-04-20	HUMAN OTC DRUG LABEL	1