ALLEROFF

Product NDC: 16853-1261
11-digit product format: 168531261
Labeler code: 16853
Product ID: 16853-1261_110b051e-8123-4443-b9c3-9e3181a528b2
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: Corporacion Infarmasa
Application: NDA022155
Marketing category: NDA
Marketing start: 2010-01-15
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 1 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	16853-1261		I	Inactivated by FDA	2026-10-05
excluded package	package	16853-1261	16853-1261-1	I	Inactivated by FDA	2026-10-05
excluded package	package	16853-1261	16853-1261-2	I	Inactivated by FDA	2026-10-05

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	16853-1261-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16853-1261-1	`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	16853-1261-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16853-1261-1	`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	16853-1261-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16853-1261-1	`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	16853-1261-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16853-1261-1	`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	16853-1261-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16853-1261-1	`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	16853-1261-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16853-1261-1	`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	16853-1261-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16853-1261-1	`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	16853-1261-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16853-1261-1	`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	16853-1261-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16853-1261-1	`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	16853-1261-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16853-1261-1	`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	16853-1261-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16853-1261-1	`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	16853-1261-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16853-1261-1	`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	16853-1261-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16853-1261-1	`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	16853-1261-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16853-1261-1	`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	16853-1261-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16853-1261-1	`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	16853-1261-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16853-1261-1	`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	16853-1261-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16853-1261-1	`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	16853-1261-2	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16853-1261-1	`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	16853-1261-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	16853-1261-1	`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	16853-1261-2	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16853-1261-1	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022155-001	CHILDREN'S ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD, RS	2007-11-16
N022155-002	CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD, RS	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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

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
16853-1261-1	2019-10-21	C162847	48780-1	956f9ecf-d0dd-621f-e053-dbdaa90a74ad	Drug Facts
16853-1261-2	2019-10-21	C162847	48780-1	956f9ecf-d0dd-621f-e053-dbdaa90a74ad	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16853-1261-1	ALLEROFF	1 in 1 CARTON	SYRUP	1		4
16853-1261-2	ALLEROFF	2 in 1 PACKAGE, COMBINATION	SYRUP	2		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4
Cetirizine	ACTIVE MOIETY	YO7261ME24	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16853-1261	ALLEROFF (CETIRIZINE HYDROCHLORIDE) SYRUP [CORPORACION INFARMASA]	4	Legacy NDC, 2 package rows	20100607_b82fbeb9-021a-484b-9896-5a5b945c5827.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	2026-01-19	Warnings	Exact identifier application applno (NDA): 022155 application number: NDA022155
Childrens Zyrtec	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	9d8e78ea-af98-4f7c-8db5-044b49582f80	2025-10-10	Warnings	Exact identifier application applno (NDA): 022155 application number: NDA022155
ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	31400cb2-fe85-ef74-e063-6294a90a11fb	2025-06-16	Warnings	Exact identifier application applno (NDA): 022155 application number: NDA022155

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
1020019	alleroff 5 MG in 5 mL Oral Solution	PSN	b82fbeb9-021a-484b-9896-5a5b945c5827	4
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	b82fbeb9-021a-484b-9896-5a5b945c5827	4
1020019	cetirizine hydrochloride 1 MG/ML Oral Solution [Alleroff]	SBD	b82fbeb9-021a-484b-9896-5a5b945c5827	4
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	b82fbeb9-021a-484b-9896-5a5b945c5827	4
1020019	Alleroff (cetirizine dihydrochloride 1 MG/ML) Oral Solution	SY	b82fbeb9-021a-484b-9896-5a5b945c5827	4
1020019	Alleroff 1 MG/ML Oral Solution	SY	b82fbeb9-021a-484b-9896-5a5b945c5827	4
1020019	Alleroff 5 MG per 5 ML Oral Solution	SY	b82fbeb9-021a-484b-9896-5a5b945c5827	4
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	b82fbeb9-021a-484b-9896-5a5b945c5827	4
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	b82fbeb9-021a-484b-9896-5a5b945c5827	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
16853-1261-1	16853126101	1 in 1 CARTON	Historical
16853-1261-2	16853126102	2 in 1 PACKAGE, COMBINATION	Historical