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 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
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 · 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078876-001	AA	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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