Cetirizine Hydrochloride (Allergy)

Product NDC: 58602-806
11-digit product format: 586020806
Labeler code: 58602
Product ID: 58602-806_a74bd49f-8718-4483-9019-b761138669c9
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA209107
Marketing category: ANDA
Marketing start: 2018-07-20
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
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 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
A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2018-07-20
A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2018-07-20

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	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209107-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2018-07-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209107-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	2018-07-20	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	10 mg/1

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
1014675	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
ffbca2a4-8df0-4c85-adf9-9414cd706fb2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58602-806-04	Cetirizine Hydrochloride (Allergy)	12 in 1 BOTTLE	CAPSULE	12	4
58602-806-04	Cetirizine Hydrochloride (Allergy)	1 in 1 CARTON	CAPSULE	1	4
58602-806-12	Cetirizine Hydrochloride (Allergy)	40 in 1 BOTTLE	CAPSULE	40	4
58602-806-12	Cetirizine Hydrochloride (Allergy)	1 in 1 CARTON	CAPSULE	1	4
58602-806-16	Cetirizine Hydrochloride (Allergy)	65 in 1 CARTON	CAPSULE	65	4
58602-806-16	Cetirizine Hydrochloride (Allergy)	65 in 1 BOTTLE	CAPSULE	65	4
58602-806-53	Cetirizine Hydrochloride (Allergy)	25 in 1 BOTTLE	CAPSULE	25	4
58602-806-53	Cetirizine Hydrochloride (Allergy)	1 in 1 CARTON	CAPSULE	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-806	CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) CAPSULE [AUROHEALTH LLC]	3	Current NDC, Legacy NDC, 8 package rows	20200915_ffbca2a4-8df0-4c85-adf9-9414cd706fb2.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	ffbca2a4-8df0-4c85-adf9-9414cd706fb2	2026-02-26	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107 ndc (product): 58602-806
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	WALGREEN CO.	3d2eac7f-db44-4771-8c7e-a38e68a7f24b	2025-04-05	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Better Living Brands, LLC	f7deb8ca-4a26-aece-e053-6294a90aa685	2023-11-22	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	1bbefda2-d3c5-4d31-b3ec-7da077e41157	2022-08-16	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	RITE AID CORPORATION	de169567-5cde-5c4a-e053-2a95a90a1215	2022-07-21	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	0b6e8c63-a76c-4184-a9cc-9691378c3ee5	2021-03-11	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107
Cetirizine Hydrochloride (Hives Relief)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	f0f486e1-2eeb-4eaa-b557-908bcbf973a8	2020-09-14	Warnings	Exact identifier application applno (ANDA): 209107 application number: ANDA209107

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
1014675	cetirizine HCl 10 MG 24HR Oral Capsule	PSN	ffbca2a4-8df0-4c85-adf9-9414cd706fb2	4
1014675	cetirizine hydrochloride 10 MG Oral Capsule	SCD	ffbca2a4-8df0-4c85-adf9-9414cd706fb2	4
1014675	cetirizine HCl 10 MG 24 HR Oral Capsule	SY	ffbca2a4-8df0-4c85-adf9-9414cd706fb2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-806-04	58602080604	1 BOTTLE in 1 CARTON (58602-806-04) / 12 CAPSULE in 1 BOTTLE	1 bottle	2018-07-20	0000-00-00	No	No	Current
58602-806-12	58602080612	1 BOTTLE in 1 CARTON (58602-806-12) / 40 CAPSULE in 1 BOTTLE	1 bottle	2018-07-20	0000-00-00	No	No	Current
58602-806-16	58602080616	65 BOTTLE in 1 CARTON (58602-806-16) / 65 CAPSULE in 1 BOTTLE	65 bottle	2018-07-20	0000-00-00	No	No	Current
58602-806-53	58602080653	1 BOTTLE in 1 CARTON (58602-806-53) / 25 CAPSULE in 1 BOTTLE	1 bottle	2018-07-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CETIRIZINE - Aurohealth LLC \| APL HEALTHCARE LIMITED \| Aurobindo Pharma Limited	Aurohealth LLC \| APL HEALTHCARE LIMITED \| Aurobindo Pharma Limited	2026-02-26	Human OTC Drug Label	4