Cetirizine Hydrochloride Oral Solution

Product NDC: 62135-057
11-digit product format: 621350057
Labeler code: 62135
Product ID: 62135-057_06fce480-76eb-a204-e063-6394a90a3bbc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cetirizine Hydrochloride Oral Solution
Dosage form: SOLUTION
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA078876
Marketing category: ANDA
Marketing start: 2012-05-11
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 5 mg/5mL
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 42.

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
A078876-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2012-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078876-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078876-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078876-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078876-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078876-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078876-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078876-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078876-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078876-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078876-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078876-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078876-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078876-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078876-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078876-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078876-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078876-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078876-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078876-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078876-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078876-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078876-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078876-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078876-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078876-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078876-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078876-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078876-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078876-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078876-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078876-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078876-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078876-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078876-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078876-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078876-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078876-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078876-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078876-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078876-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078876-001	AA	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	5 mg/5mL

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
41dc7107-a2d2-4519-ac6f-cbed9f07e9bf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
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
62135-057-41	Cetirizine Hydrochloride Oral Solution	120 mL in 1 BOTTLE	SOLUTION	120		2
62135-057-47	Cetirizine Hydrochloride Oral Solution	473 mL in 1 BOTTLE	SOLUTION	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-057-41	ML - Milliliter	62135-057	e031eb44-cf69-4a5f-9839-dd66d3cff02c	1	2022-09-12
62135-057-47	ML - Milliliter	62135-057	513d5160-11f6-464b-941e-6fba2efce9ae	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-057	CETIRIZINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [CHARTWELL RX, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20231006_41dc7107-a2d2-4519-ac6f-cbed9f07e9bf.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
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aventura Pharmaceuticals, LLC	aeb73ab9-3b05-4062-a7fd-352cf2094a56	2025-10-02	Adverse reactions	Exact identifier application applno (ANDA): 078876 application number: ANDA078876
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	a9b21d71-106e-4bd5-aaab-9254c8a44e0d	2025-02-12	Adverse reactions	Exact identifier application applno (ANDA): 078876 application number: ANDA078876
Cetirizine Hydrochloride Oral Solution	CETIRIZINE HYDROCHLORIDE ORAL SOLUTION	Chartwell RX, LLC	41dc7107-a2d2-4519-ac6f-cbed9f07e9bf	2023-10-05	Adverse reactions	Exact identifier application applno (ANDA): 078876 application number: ANDA078876 ndc (product): 62135-057

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	41dc7107-a2d2-4519-ac6f-cbed9f07e9bf	2
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	41dc7107-a2d2-4519-ac6f-cbed9f07e9bf	2
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	41dc7107-a2d2-4519-ac6f-cbed9f07e9bf	2
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	41dc7107-a2d2-4519-ac6f-cbed9f07e9bf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62135-057-41	62135005741	120 mL in 1 BOTTLE (62135-057-41)	120 ml	2022-06-08	0000-00-00	No	No	Current
62135-057-47	62135005747	473 mL in 1 BOTTLE (62135-057-47)	473 ml	2022-06-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Oral Solution, USP For Oral Use Rx only	Chartwell RX, LLC	2023-10-05	HUMAN PRESCRIPTION DRUG LABEL	2