Cetirizine HCl

Product NDC: 46122-613
Requested package NDC: 46122-613-63
11-digit product format: 461220613
Labeler code: 46122
Product ID: 46122-613_df610219-ee3e-1e7e-e053-2995a90a94a3
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: AMERISOURCE BERGEN
Application: NDA022429
Marketing category: NDA
Marketing start: 2019-06-18
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 44.

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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
75f2649d-005e-4f16-a7c3-ae966f3a7a00	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	Strength	SPL version
46122-613-63	Cetirizine HCl	1 in 1 CARTON	CAPSULE	1		2
46122-613-63	Cetirizine HCl	25 in 1 BOTTLE, PLASTIC	CAPSULE	25		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-613-63	EA - Each	46122-613	981f5d62-a407-465c-a7c5-1e0508e20710	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-613	CETIRIZINE HCL CAPSULE [AMERISOURCE BERGEN]	2	Current NDC, Legacy NDC, 2 package rows	20220520_75f2649d-005e-4f16-a7c3-ae966f3a7a00.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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Cetirizine HCl	CETIRIZINE HCL	AMERISOURCE BERGEN	75f2649d-005e-4f16-a7c3-ae966f3a7a00	2022-05-19	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429 ndc (package): 46122-613-63 ndc (product): 46122-613 ndc11 (package): 46122061363
all day allergy	CETIRIZINE HCL	SUPERVALU INC	ca0da001-0d38-43e9-8ab1-c7c217f88bce	2018-12-31	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	75f2649d-005e-4f16-a7c3-ae966f3a7a00	2
1014675	cetirizine hydrochloride 10 MG Oral Capsule	SCD	75f2649d-005e-4f16-a7c3-ae966f3a7a00	2
1014675	cetirizine HCl 10 MG 24 HR Oral Capsule	SY	75f2649d-005e-4f16-a7c3-ae966f3a7a00	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46122-613-63	46122061363	1 BOTTLE, PLASTIC in 1 CARTON (46122-613-63) / 25 CAPSULE in 1 BOTTLE, PLASTIC	2019-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	AMERISOURCE BERGEN \| Bionpharma Inc. \| Patheon Softgels Inc.	2022-05-19	HUMAN OTC DRUG LABEL	2