Allergy Relief

Product NDC: 37808-564
11-digit product format: 378080564
Labeler code: 37808
Product ID: 37808-564_dc1a3b00-493f-49ca-ad0a-7281eb9a726d
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: H E B
Application: ANDA213105
Marketing category: ANDA
Marketing start: 2021-10-15
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2020-09-21

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.

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	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Allergy Relief
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
4bbf0be5-7bcc-46c6-a443-7b37d4679c6f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
37808-564-25	Allergy Relief	25 in 1 BOTTLE	CAPSULE	25	5
37808-564-25	Allergy Relief	1 in 1 BOX	CAPSULE	1	5
37808-564-40	Allergy Relief	1 in 1 BOX	CAPSULE	1	5
37808-564-40	Allergy Relief	40 in 1 BOTTLE, PLASTIC	CAPSULE	40	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-564	ALLERGY RELIEF (CETIRIZINE HCL) CAPSULE [H E B]	5	Current NDC, Legacy NDC, 4 package rows	20240511_4bbf0be5-7bcc-46c6-a443-7b37d4679c6f.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE HCL	WALMART INC. (see also Equate)	967be504-85b1-4e9b-9b08-2b27a43fa0aa	2026-06-18	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
Allergy Relief	CETIRIZINE HCL	CVS PHARMACY, INC	fb850a4c-7ac1-4993-b6ea-5c8d42e17703	2026-05-18	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
All Day Allergy	CETIRIZINE HCL	WALMART INC. (see also Equate)	c8016d34-aa72-4857-b5ed-5476948b386a	2026-02-20	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
Allergy Relief	CETIRIZINE HCL	Safeway, Inc.	1fbb274c-cacc-4ba9-be97-33d83e2773db	2025-12-16	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
ZYRTEC Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	0face45c-af24-3559-e063-6294a90abde5	2025-10-21	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
All Day Allergy Relief	CETIRIZINE HCL	P & L Development, LLC	7dabf6bd-8a96-4e7f-bc19-5a47cec36419	2025-05-16	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
basic care all day allergy	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	e71e259a-494e-4a9a-b0e4-25bd25dd0e07	2025-04-06	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
Allergy Relief	CETIRIZINE HCL	H E B	4bbf0be5-7bcc-46c6-a443-7b37d4679c6f	2024-05-10	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 37808-564
topcare all day allergy	CETIRIZINE HYDROCHLORIDE	Topco Associates LLC	10c512a1-bb96-4d2a-9e41-a422efb57e28	2023-02-09	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
Allergy Relief	CETIRIZINE HCL	Publix Supermarkets, Inc.	cb70ca8b-847f-4122-b86f-bf5d39e2a83b	2022-11-08	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
Allergy Relief	CETIRIZINE HCL	CVS PHARMACY, INC	ed8951a1-bd7e-439d-a427-685d56a9c9ad	2022-11-07	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
careone allergy relief	CETIRIZINE HYDROCHLORIDE	Retail Business Services, LLC	6d94d302-b79a-4143-bb3c-c74da2a6a72e	2022-10-20	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
Allergy Relief	CETIRIZINE HCL	Care One (Retail Business Services, LLC.)	04a6087e-d854-4e70-9d89-3971890a44a3	2022-10-20	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
Good Sense All Day Allergy	CETIRIZINE HYDROCHLORIDE	L. Perrigo Company	5b1203c7-9678-4cee-9d7b-6510da295561	2022-09-08	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
dg health all day allergy	CETIRIZINE HYDROCHLORIDE	Dolgencorp Inc	6baa66e7-93df-43d9-a301-5d9c14274c99	2022-04-01	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
allergy relief	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	268170c9-b6a7-4851-b7d3-33dd1d733e39	2022-03-07	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105

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	4bbf0be5-7bcc-46c6-a443-7b37d4679c6f	5
1014675	cetirizine hydrochloride 10 MG Oral Capsule	SCD	4bbf0be5-7bcc-46c6-a443-7b37d4679c6f	5
1014675	cetirizine HCl 10 MG 24 HR Oral Capsule	SY	4bbf0be5-7bcc-46c6-a443-7b37d4679c6f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-564-25	37808056425	1 BOTTLE in 1 BOX (37808-564-25) / 25 CAPSULE in 1 BOTTLE	1 bottle	2021-10-15	0000-00-00	No	No	Current
37808-564-40	37808056440	1 BOTTLE, PLASTIC in 1 BOX (37808-564-40) / 40 CAPSULE in 1 BOTTLE, PLASTIC		2021-10-15		No	No	Current