CETIRIZINE HYDROCHLORIDE

Product NDC: 61037-480
11-digit product format: 610370480
Labeler code: 61037
Product ID: 61037-480_3ba3f1a6-e1ea-f193-e063-6394a90ad645
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: BAJAJ MEDICAL, LLC
Application: ANDA091327
Marketing category: ANDA
Marketing start: 2025-05-08
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2011-10-17
A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2011-10-17

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-10-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-10-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-10-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-10-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-10-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-10-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-10-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-10-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-10-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-10-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-10-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-10-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091327-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-10-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091327-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-10-17	`782e0a99824c…`

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
36b6d0e4-8da5-9df5-e063-6294a90af326	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	SPL version
61037-480-02	CETIRIZINE HYDROCHLORIDE	120 mL in 1 BOTTLE, PLASTIC	SOLUTION	120	3
61037-480-03	CETIRIZINE HYDROCHLORIDE	480 mL in 1 BOTTLE, PLASTIC	SOLUTION	480	3
61037-480-04	CETIRIZINE HYDROCHLORIDE	240 mL in 1 BOTTLE, PLASTIC	SOLUTION	240	3
61037-480-06	CETIRIZINE HYDROCHLORIDE	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	3
61037-480-12	CETIRIZINE HYDROCHLORIDE	5 mL in 1 BOX, UNIT-DOSE	SOLUTION	5	3
61037-480-22	CETIRIZINE HYDROCHLORIDE	120 mL in 1 BOTTLE, PLASTIC	SOLUTION	120	3
61037-480-23	CETIRIZINE HYDROCHLORIDE	480 mL in 1 BOTTLE, PLASTIC	SOLUTION	480	3
61037-480-24	CETIRIZINE HYDROCHLORIDE	240 mL in 1 BOTTLE, PLASTIC	SOLUTION	240	3
61037-480-26	CETIRIZINE HYDROCHLORIDE	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	3
61037-480-32	CETIRIZINE HYDROCHLORIDE	5 mL in 1 BOX, UNIT-DOSE	SOLUTION	5	3

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	06cdcbe0-6c7c-4b91-8158-08ef2e0876dc	2025-10-08	Warnings	Exact identifier application applno (ANDA): 091327 application number: ANDA091327
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	c6f08e78-10fc-48d0-a3e1-e227081548eb	2025-10-07	Warnings	Exact identifier application applno (ANDA): 091327 application number: ANDA091327
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	BAJAJ MEDICAL, LLC	36b6d0e4-8da5-9df5-e063-6294a90af326	2025-08-05	Warnings	Exact identifier application applno (ANDA): 091327 application number: ANDA091327 ndc (product): 61037-480
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	BAJAJ MEDICAL, LLC	36b24a3c-6284-5a6d-e063-6394a90a7743	2025-08-05	Warnings	Exact identifier application applno (ANDA): 091327 application number: ANDA091327 ndc (product): 61037-480

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	36b24a3c-6284-5a6d-e063-6394a90a7743	3
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	36b6d0e4-8da5-9df5-e063-6294a90af326	3
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	36b24a3c-6284-5a6d-e063-6394a90a7743	3
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	36b6d0e4-8da5-9df5-e063-6294a90af326	3
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	36b24a3c-6284-5a6d-e063-6394a90a7743	3
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	36b6d0e4-8da5-9df5-e063-6294a90af326	3
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	36b24a3c-6284-5a6d-e063-6394a90a7743	3
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	36b6d0e4-8da5-9df5-e063-6294a90af326	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61037-480-02	61037048002	120 mL in 1 BOTTLE, PLASTIC (61037-480-02)	120 ml	2025-05-08	No	No	Current
61037-480-03	61037048003	480 mL in 1 BOTTLE, PLASTIC (61037-480-03)	480 ml	2025-05-08	No	No	Current
61037-480-04	61037048004	240 mL in 1 BOTTLE, PLASTIC (61037-480-04)	240 ml	2025-05-08	No	No	Current
61037-480-06	61037048006	5 mL in 1 CUP, UNIT-DOSE (61037-480-06)	5 ml	2025-05-08	No	No	Current
61037-480-12	61037048012	5 mL in 1 BOX, UNIT-DOSE (61037-480-12)	5 ml	2025-05-08	No	No	Current
61037-480-22	61037048022	120 mL in 1 BOTTLE, PLASTIC (61037-480-22)	120 ml	2025-05-08	No	No	Current
61037-480-23	61037048023	480 mL in 1 BOTTLE, PLASTIC (61037-480-23)	480 ml	2025-05-08	No	No	Current
61037-480-24	61037048024	240 mL in 1 BOTTLE, PLASTIC (61037-480-24)	240 ml	2025-05-08	No	No	Current
61037-480-26	61037048026	5 mL in 1 CUP, UNIT-DOSE (61037-480-26)	5 ml	2025-05-08	No	No	Current
61037-480-32	61037048032	5 mL in 1 BOX, UNIT-DOSE (61037-480-32)	5 ml	2025-05-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALLERGY Children’s Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL 2 yrs. & older	BAJAJ MEDICAL, LLC	2025-08-05	HUMAN OTC DRUG LABEL	3
HIVES Children’s Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL 6 yrs. & older	BAJAJ MEDICAL, LLC	2025-08-05	HUMAN OTC DRUG LABEL	3