Cetirizine Hydrochloride

Product NDC: 63187-436
11-digit product format: 631870436
Labeler code: 63187
Product ID: 63187-436_94b97b2e-11b6-42ad-96f5-3d4030347dd7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA078488
Marketing category: ANDA
Marketing start: 2013-12-03
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63187-436		D	Discontinued by firm		2026-10-05
excluded package	package	63187-436	63187-436-04	D	Discontinued by firm		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 1 · 4 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	63187-436-04	`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	63187-436-04	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078488-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2008-10-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078488-001	AA

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2008-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078488-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-10-06	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078488-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078488-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078488-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078488-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078488-001	AA	1	`6a471c1ec25d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078488-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078488-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078488-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078488-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078488-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078488-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078488-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078488-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078488-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078488-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078488-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078488-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078488-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078488-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078488-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078488-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078488-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078488-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078488-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078488-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078488-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078488-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078488-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078488-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078488-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078488-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078488-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078488-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078488-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078488-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078488-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078488-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078488-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078488-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078488-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1
Cetirizine	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1
acetic acid	INACTIVE INGREDIENT	Q40Q9N063P	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1
banana	INACTIVE INGREDIENT	4AJZ4765R9	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1
grape	INACTIVE INGREDIENT	6X543N684K	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1
sodium acetate	INACTIVE INGREDIENT	4550K0SC9B	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-436	CETIRIZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]	3	Legacy NDC	20200219_26d8bc1c-59bc-425a-bdb0-5f97e6dcdbe0.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	Bionpharma Inc.	41d7af88-87b4-370e-e063-6294a90a8af6	2025-10-24	Adverse reactions	Exact identifier application applno (ANDA): 078488 application number: ANDA078488

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
63187-436-04	63187043604	120 mL in 1 BOTTLE, GLASS (63187-436-04)	120 ml	2019-01-01	0000-00-00	No	No	Current