ALLEROFF

Product NDC: 16853-1305
11-digit product format: 168531305
Labeler code: 16853
Product ID: 16853-1305_98661a3c-c95c-4ab1-b62f-87dde7f88296
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Corporacion Infarmasa
Application: NDA019835
Marketing category: NDA
Marketing start: 2010-01-01
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16853-1305		I	Inactivated by FDA	2026-08-17
excluded package	package	16853-1305	16853-1305-2	I	Inactivated by FDA	2026-08-17
excluded package	package	16853-1305	16853-1305-3	I	Inactivated by FDA	2026-08-17

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 2 · 66 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	16853-1305-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16853-1305-2	`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	16853-1305-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16853-1305-2	`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	16853-1305-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16853-1305-2	`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	16853-1305-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16853-1305-2	`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	16853-1305-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16853-1305-2	`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	16853-1305-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16853-1305-2	`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	16853-1305-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16853-1305-2	`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	16853-1305-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16853-1305-2	`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	16853-1305-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16853-1305-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16853-1305-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16853-1305-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16853-1305-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16853-1305-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16853-1305-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16853-1305-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16853-1305-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16853-1305-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16853-1305-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16853-1305-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16853-1305-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16853-1305-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16853-1305-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16853-1305-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16853-1305-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16853-1305-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16853-1305-3	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16853-1305-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	16853-1305-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	16853-1305-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16853-1305-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16853-1305-2	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019835-003	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	2007-11-16
N019835-004	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RLD, RS	2007-11-16
N019835-005	ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	2007-11-16
N019835-006	ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RLD	2007-11-16

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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`d8e5a09893c0…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16853-1305-2	2019-10-21	C162847	48780-1	956f9ecf-cea6-621f-e053-dbdaa90a74ad	Drug Facts
16853-1305-3	2019-10-21	C162847	48780-1	956f9ecf-cea6-621f-e053-dbdaa90a74ad	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16853-1305-1	ALLEROFF	000000000010 in 1 BLISTER PACK	TABLET	000000000010	2
16853-1305-2	ALLEROFF	00000000000001 in 1 BOX	TABLET	00000000000001	2
16853-1305-3	ALLEROFF	0000000002 in 1 BLISTER PACK	TABLET	0000000002	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]	2
Cetirizine	ACTIVE MOIETY	YO7261ME24	ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16853-1305	ALLEROFF (CETIRIZINE HYDROCHLORIDE) TABLET [CORPORACION INFARMASA]	2	Legacy NDC, 3 package rows	20100603_2e431020-bf57-46a7-bbfd-487b87d00ffb.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Select Consumer Group	568960cf-2c8f-f1b0-e063-6294a90aebc7	2026-07-13	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Savings Distributors LLC	5490c38a-91d7-9ee1-e063-6394a90a1ea5	2026-06-01	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	b165db38-b302-4220-8627-77cb07bb078c	2025-10-10	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	6685a843-9dbe-4f9e-b75b-fe0e258f4155	2025-10-08	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	2c1ecee3-c2c1-25a2-e063-6294a90aad54	2025-07-21	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Morning Star OTC	3efa421d-ea70-4b1f-95d0-7c63b6c39580	2025-06-19	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
ZYRTEC Hives	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	31136e3a-94fa-0860-e063-6394a90a008d	2025-06-16	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	RedPharm Drug Inc	f4c1f9fd-2d32-71d3-e053-2a95a90a3ba4	2025-01-23	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec 1s Blister	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	3a595eb8-2409-4598-8704-ab59b57bd062	2024-12-31	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec 2s Blister	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	af0ba7b0-b511-9f81-e053-2a95a90ade2c	2024-12-31	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc	a4146629-57f0-42e0-b905-df364a8a99f5	2024-12-31	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy, Lil Drug Store	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED	Lil' Drug Store Products, Inc.	1b6c945f-591f-8869-e063-6294a90ad397	2024-06-21	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Navajo Manufacturing Company Incorporated	9c4693cb-f066-0666-e053-2a95a90a96d3	2023-03-16	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835

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
1020025	Alleroff 10 MG Oral Tablet	PSN	2e431020-bf57-46a7-bbfd-487b87d00ffb	2
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	2e431020-bf57-46a7-bbfd-487b87d00ffb	2
1020025	cetirizine hydrochloride 10 MG Oral Tablet [Alleroff]	SBD	2e431020-bf57-46a7-bbfd-487b87d00ffb	2
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	2e431020-bf57-46a7-bbfd-487b87d00ffb	2
1020025	Alleroff (cetirizine dihydrochloride 10 MG) Oral Tablet	SY	2e431020-bf57-46a7-bbfd-487b87d00ffb	2
1020025	Alleroff 10 MG Oral Tablet	SY	2e431020-bf57-46a7-bbfd-487b87d00ffb	2
1014678	cetirizine HCl 10 MG Oral Tablet	SY	2e431020-bf57-46a7-bbfd-487b87d00ffb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
16853-1305-1	16853130501	000000000010 in 1 BLISTER PACK	Historical
16853-1305-2	16853130502	00000000000001 in 1 BOX	Historical
16853-1305-3	16853130503	0000000002 in 1 BLISTER PACK	Historical