Cetirizine Hydrochloride (Allergy)

Product NDC: 0363-0068
Requested package NDC: 0363-0068-53
11-digit product format: 003630068
Labeler code: 0363
Product ID: 0363-0068_5d00aeb2-1ed9-4d51-a939-e137af4608f2
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: WALGREEN CO.
Application: ANDA209107
Marketing category: ANDA
Marketing start: 2020-06-08
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: 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
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…`

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 · 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
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 ndc (package): 0363-0068-53 ndc (product): 0363-0068 ndc11 (package): 00363006853
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

Additional Listing Data#

Finished product: Yes
Brand name base: Cetirizine Hydrochloride (Allergy)
Listing expiration: 2026-12-31

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
3d2eac7f-db44-4771-8c7e-a38e68a7f24b	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
0363-0068-12	Cetirizine Hydrochloride (Allergy)	1 in 1 CARTON	CAPSULE	1	5
0363-0068-12	Cetirizine Hydrochloride (Allergy)	40 in 1 BOTTLE	CAPSULE	40	5
0363-0068-53	Cetirizine Hydrochloride (Allergy)	1 in 1 CARTON	CAPSULE	1	5
0363-0068-53	Cetirizine Hydrochloride (Allergy)	25 in 1 BOTTLE	CAPSULE	25	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0068	CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) CAPSULE [WALGREEN CO.]	5	Current NDC, Legacy NDC, 4 package rows	20250410_3d2eac7f-db44-4771-8c7e-a38e68a7f24b.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
1014675	cetirizine HCl 10 MG 24HR Oral Capsule	PSN	3d2eac7f-db44-4771-8c7e-a38e68a7f24b	5
1014675	cetirizine hydrochloride 10 MG Oral Capsule	SCD	3d2eac7f-db44-4771-8c7e-a38e68a7f24b	5
1014675	cetirizine HCl 10 MG 24 HR Oral Capsule	SY	3d2eac7f-db44-4771-8c7e-a38e68a7f24b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0068-53	00363006853	1 BOTTLE in 1 CARTON (0363-0068-53) / 25 CAPSULE in 1 BOTTLE	1 bottle	2020-06-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride (Allergy) - WALGREEN CO. \| Aurohealth LLC \| APL HEALTHCARE LIMITED \| Aurobindo Pharma Limited	WALGREEN CO. \| Aurohealth LLC \| APL HEALTHCARE LIMITED \| Aurobindo Pharma Limited	2025-04-05	Human OTC Drug Label	5