Childrens Cetirizine Hydrochloride Allergy

Product NDC: 58602-028
11-digit product format: 586020028
Labeler code: 58602
Product ID: 58602-028_e407f522-6f4f-4049-a2df-23cb18c1eb1f
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA090750
Marketing category: ANDA
Marketing start: 2015-06-24
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: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2010-02-02
A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2010-02-02

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2010-02-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2010-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090750-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2010-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090750-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2010-02-02	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Cetirizine Hydrochloride Allergy
Listing expiration: 2027-12-31

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
4de4f544-79cd-4a89-aafb-f2e2688b3c81	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
58602-028-20	Childrens Cetirizine Hydrochloride Allergy	1 in 1 CARTON	SOLUTION	1	6
58602-028-20	Childrens Cetirizine Hydrochloride Allergy	240 mL in 1 BOTTLE	SOLUTION	240	6
58602-028-24	Childrens Cetirizine Hydrochloride Allergy	120 mL in 1 BOTTLE	SOLUTION	120	6
58602-028-24	Childrens Cetirizine Hydrochloride Allergy	1 in 1 CARTON	SOLUTION	1	6
58602-028-26	Childrens Cetirizine Hydrochloride Allergy	480 mL in 1 BOTTLE	SOLUTION	480	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-028	CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]	4	Current NDC, Legacy NDC, 5 package rows	20221104_4de4f544-79cd-4a89-aafb-f2e2688b3c81.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy Relief	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	52dc28ac-4059-4b6c-8bbc-22aa479a549a	2026-03-09	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750
Childrens Cetirizine Hydrochloride Allergy	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	4de4f544-79cd-4a89-aafb-f2e2688b3c81	2026-03-09	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750 ndc (product): 58602-028
Childrens Cetirizine Hydrochloride Hives Relief	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	bd489217-bf7c-429b-a58c-426104f7e779	2025-12-16	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750
Childrens Cetirizine Hydrochloride Hives Relief	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	e000848a-8bbe-4149-bdcb-d7b4b0bd4d0d	2025-12-09	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Fred's, Inc.	55e799b2-e325-4286-aa9a-b88e99ab1146	2020-12-13	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	C.D.M.A., Inc.	b4feed95-86ca-411c-99b5-773e485e752f	2020-12-13	Warnings	Exact identifier application applno (ANDA): 090750 application number: ANDA090750

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	4de4f544-79cd-4a89-aafb-f2e2688b3c81	6
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	4de4f544-79cd-4a89-aafb-f2e2688b3c81	6
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	4de4f544-79cd-4a89-aafb-f2e2688b3c81	6
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	4de4f544-79cd-4a89-aafb-f2e2688b3c81	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-028-20	58602002820	1 BOTTLE in 1 CARTON (58602-028-20) / 240 mL in 1 BOTTLE	1 bottle	2015-06-24	0000-00-00	No	No	Current
58602-028-24	58602002824	1 BOTTLE in 1 CARTON (58602-028-24) / 120 mL in 1 BOTTLE	1 bottle	2015-06-24	0000-00-00	No	No	Current
58602-028-26	58602002826	480 mL in 1 BOTTLE (58602-028-26)	480 ml	2015-06-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride - Aurohealth LLC \| Aurobindo Pharma Limited	Aurohealth LLC \| Aurobindo Pharma Limited	2026-03-09	Human OTC Drug Label	6