Cetirizine Hydrochloride

Product NDC: 47335-344
11-digit product format: 473350344
Labeler code: 47335
Product ID: 47335-344_650b77fc-76c9-4ab9-a671-d72f6def4c42
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA090142
Marketing category: ANDA
Marketing start: 2011-09-09
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	47335-344		D	Discontinued by firm	2026-08-03
excluded product	product	47335-344		D	Discontinued by firm	2026-08-03
excluded package	package	47335-344	47335-344-83	D	Discontinued by firm	2026-08-03
excluded package	package	47335-344	47335-344-88	D	Discontinued by firm	2026-08-03
excluded package	package	47335-344	47335-344-15	D	Discontinued by firm	2026-08-03
excluded package	package	47335-344	47335-344-16	D	Discontinued by firm	2026-08-03

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	47335-344-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	47335-344-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	47335-344-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	47335-344-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	47335-344-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	47335-344-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	47335-344-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	47335-344-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	47335-344-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	47335-344-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	47335-344-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	47335-344-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	47335-344-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	47335-344-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	47335-344-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	47335-344-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	47335-344-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	47335-344-15	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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
47335-344-83	Cetirizine Hydrochloride	30 in 1 BOTTLE	TABLET, CHEWABLE	30		12
47335-344-88	Cetirizine Hydrochloride	100 in 1 BOTTLE	TABLET, CHEWABLE	100		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-344-83	EA - Each	47335-344	2f6a2325-3993-475b-ac3a-8bd9cdfb34b7	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	5
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-344	CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20240920_a4758152-97dd-4a27-b4d9-11178654b93e.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

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
1014674	cetirizine HCl 10 MG Chewable Tablet	PSN	a4758152-97dd-4a27-b4d9-11178654b93e	12
1014643	cetirizine HCl 5 MG Chewable Tablet	PSN	a4758152-97dd-4a27-b4d9-11178654b93e	12
1014674	cetirizine hydrochloride 10 MG Chewable Tablet	SCD	a4758152-97dd-4a27-b4d9-11178654b93e	12
1014643	cetirizine hydrochloride 5 MG Chewable Tablet	SCD	a4758152-97dd-4a27-b4d9-11178654b93e	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-344-15	47335034415	30 TABLET, CHEWABLE in 1 BOTTLE (47335-344-15)	2011-09-26	0000-00-00	No	No	Current
47335-344-16	47335034416	100 TABLET, CHEWABLE in 1 BOTTLE (47335-344-16)	2011-09-26	0000-00-00	No	No	Current
47335-344-83	47335034483	30 TABLET, CHEWABLE in 1 BOTTLE (47335-344-83)	2011-09-09	0000-00-00	No	No	Current
47335-344-88	47335034488	100 TABLET, CHEWABLE in 1 BOTTLE (47335-344-88)	2011-09-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Chewable Tablets	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited \| Taro Pharmaceutical Industries Ltd	2026-04-21	Human OTC Drug Label	12
Cetirizine Hydrochloride Chewable Tablets	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2018-10-26	Human OTC Drug Label	2