Cetirizine Hydrochloride

Product NDC: 51660-066
11-digit product format: 516600066
Labeler code: 51660
Product ID: 51660-066_1ae46a4b-8176-44fc-bc57-ed9e62c02746
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: OHM LABORATORIES INC.
Application: ANDA090142
Marketing category: ANDA
Marketing start: 2022-07-21
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	Approval date
A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2011-08-30
A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2011-08-30
A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2011-08-30
A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2011-08-30

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cetirizine Hydrochloride
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
1014674	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
97802669-b4bd-4807-b3c1-6c6f5a2b0c67	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51660-066-30	Cetirizine Hydrochloride	30 in 1 BOTTLE	TABLET, CHEWABLE	30		1
51660-066-30	Cetirizine Hydrochloride	1 in 1 CARTON	TABLET, CHEWABLE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51660-066	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [OHM LABORATORIES INC.]	1	Current NDC, Legacy NDC, 2 package rows	20220731_97802669-b4bd-4807-b3c1-6c6f5a2b0c67.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	OHM LABORATORIES INC.	97802669-b4bd-4807-b3c1-6c6f5a2b0c67	2026-06-03	Warnings	Exact identifier application applno (ANDA): 090142 application number: ANDA090142 ndc (product): 51660-066

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51660-066-30	51660006630	1 BOTTLE in 1 CARTON (51660-066-30) / 30 TABLET, CHEWABLE in 1 BOTTLE	1 bottle	2022-07-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride	OHM LABORATORIES INC. \| Taro Pharmaceutical Industries Ltd.	2026-06-03	HUMAN OTC DRUG LABEL	2