Cetirizine Hydrochloride

Product NDC: 0121-0874
11-digit product format: 001210874
Labeler code: 0121
Product ID: 0121-0874_31dc1106-c6ed-4dcd-81e3-206cbd47017b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA078412
Marketing category: ANDA
Marketing start: 2024-02-12
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: 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078412-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2008-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078412-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2008-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2008-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078412-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2008-06-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078412-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078412-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078412-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078412-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078412-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078412-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078412-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078412-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078412-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078412-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078412-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078412-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078412-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078412-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078412-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078412-001	AA	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078412-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cetirizine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	1 mg/mL

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
1014673	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
71448ab0-e23e-4cf7-940e-7d67e7362fb4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0121-0874-04	Cetirizine Hydrochloride	120 mL in 1 BOTTLE	SOLUTION	120		5
0121-0874-16	Cetirizine Hydrochloride	480 mL in 1 BOTTLE	SOLUTION	480		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0874-04	ML - Milliliter	0121-0874	ee8dd89b-3c9d-4922-8833-172a8a1b5a44	1	2024-07-12
0121-0874-16	ML - Milliliter	0121-0874	5349a130-cfae-4e58-9817-4f9d36366305	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0874	CETIRIZINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	3	Current NDC, 2 package rows	20240621_71448ab0-e23e-4cf7-940e-7d67e7362fb4.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	PAI Holdings, LLC dba PAI Pharma	71448ab0-e23e-4cf7-940e-7d67e7362fb4	2024-06-19	Adverse reactions	Exact identifier application applno (ANDA): 078412 application number: ANDA078412 ndc (product): 0121-0874

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
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	71448ab0-e23e-4cf7-940e-7d67e7362fb4	5
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	71448ab0-e23e-4cf7-940e-7d67e7362fb4	5
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	71448ab0-e23e-4cf7-940e-7d67e7362fb4	5
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	71448ab0-e23e-4cf7-940e-7d67e7362fb4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0121-0874-04	00121087404	120 mL in 1 BOTTLE (0121-0874-04)	120 ml	2024-06-21	No	No	Current
0121-0874-16	00121087416	480 mL in 1 BOTTLE (0121-0874-16)	480 ml	2024-02-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP For Oral Use Rx Only	PAI Holdings, LLC dba PAI Pharma	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	5