Allergy Relief

Product NDC: 49035-841
11-digit product format: 490350841
Labeler code: 49035
Product ID: 49035-841_b808e3da-f23f-4ba1-970e-430bf2e204ba
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application: ANDA207235
Marketing category: ANDA
Marketing start: 2018-03-31
Marketing end: 2027-01-31
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
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
A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2016-08-12

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 2 · 41 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	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207235-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2016-08-12	`cb3db0bc1861…`

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
All Day Allergy Relief	CETIRIZINE HCL	P & L Development, LLC	0fb52421-a327-4747-880f-d2b7608ccd65	2025-11-17	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235
Allergy Relief	CETIRIZINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	d1703629-a641-403f-b547-032a75489d09	2025-07-01	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235 ndc (product): 49035-841
basic care all day allergy	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	c3e987c5-7ca1-4514-aa0a-6668ff2937c5	2022-01-04	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235
CareOne Allergy Relief	CETIRIZINE HYDROCHLORIDE	American Sales Company	833e8904-d37d-4478-af7c-8287f2d079a7	2021-08-16	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235
dg health all day allergy	CETIRIZINE HYDROCHLORIDE	Dolgencorp, LLC	ba7d3995-c992-457c-a628-f036d77cc638	2021-06-01	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235
top care all day allergy	CETIRIZINE HYDROCHLORIDE	Topco Associates LLC	1a217b8a-621a-4b6d-a7ed-37b04f829d66	2020-06-08	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235
24 hour allergy	CETIRIZINE HYDROCHLORIDE	Meijer Distribution Inc	e64db82c-6632-421e-8212-e0879445c4d6	2020-06-04	Warnings	Exact identifier application applno (ANDA): 207235 application number: ANDA207235

Additional Listing Data#

Finished product: Yes
Brand name base: Allergy Relief

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
d1703629-a641-403f-b547-032a75489d09	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	Strength	SPL version
49035-841-25	Allergy Relief	1 in 1 BOX	CAPSULE	1		4
49035-841-25	Allergy Relief	25 in 1 BOTTLE	CAPSULE	25		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-841	ALLERGY RELIEF (CETIRIZINE HCL) CAPSULE [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]	3	Current NDC, Legacy NDC, 2 package rows	20221206_d1703629-a641-403f-b547-032a75489d09.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	d1703629-a641-403f-b547-032a75489d09	4
1014675	cetirizine hydrochloride 10 MG Oral Capsule	SCD	d1703629-a641-403f-b547-032a75489d09	4
1014675	cetirizine HCl 10 MG 24 HR Oral Capsule	SY	d1703629-a641-403f-b547-032a75489d09	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-841-25	49035084125	1 BOTTLE in 1 BOX (49035-841-25) / 25 CAPSULE in 1 BOTTLE	1 bottle	2018-03-31	2027-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Tablets	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	2025-07-01	HUMAN OTC DRUG LABEL	4