equate allergy relief

Product NDC: 49035-458
11-digit product format: 490350458
Labeler code: 49035
Product ID: 49035-458_778691fe-e505-40b6-91e7-b81ae4fa45c9
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Wal-Mart Stores Inc
Application: ANDA078336
Marketing category: ANDA
Marketing start: 2008-01-09
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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27
A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: equate allergy relief
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
1014678	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
b33eb97f-5ac3-4eb7-b23a-cf550ce46287	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
49035-458-48	equate allergy relief	90 in 1 BOTTLE	TABLET, FILM COATED	90	5
49035-458-48	equate allergy relief	2 in 1 CARTON	TABLET, FILM COATED	2	5
49035-458-66	equate allergy relief	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	5
49035-458-66	equate allergy relief	14 in 1 CARTON	TABLET, FILM COATED	14	5
49035-458-75	equate allergy relief	1 in 1 CARTON	TABLET, FILM COATED	1	5
49035-458-75	equate allergy relief	90 in 1 BOTTLE	TABLET, FILM COATED	90	5
49035-458-87	equate allergy relief	300 in 1 BOTTLE	TABLET, FILM COATED	300	5
49035-458-87	equate allergy relief	1 in 1 CARTON	TABLET, FILM COATED	1	5
49035-458-95	equate allergy relief	45 in 1 BOTTLE	TABLET, FILM COATED	45	5
49035-458-95	equate allergy relief	1 in 1 CARTON	TABLET, FILM COATED	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-458-66	EA - Each	49035-458	9ceb36ba-c804-4b1a-acd7-7e325d86f259	1	2017-05-03
49035-458-75	EA - Each	49035-458	d6cb78c3-1be6-4b1c-867a-5306156473e9	1	2013-06-04
49035-458-87	EA - Each	49035-458	e40f98de-b025-4a92-8786-ef30c1d77614	1	2022-12-07
49035-458-95	EA - Each	49035-458	3aa683cb-0498-47e6-b465-75a55cdea090	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WAL-MART STORES INC]	2
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WAL-MART STORES INC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WAL-MART STORES INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WAL-MART STORES INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WAL-MART STORES INC]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WAL-MART STORES INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WAL-MART STORES INC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WAL-MART STORES INC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WAL-MART STORES INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WAL-MART STORES INC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WAL-MART STORES INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-458	EQUATE ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES INC]	5	Current NDC, Legacy NDC, 10 package rows	20240928_b33eb97f-5ac3-4eb7-b23a-cf550ce46287.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 3 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
betr remedies all day allergy relief	CETIRIZINE HYDROCHLORIDE	Live Betr LLC	4a017852-db01-4085-8947-d92a19ec4e5c	2023-05-10	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	198ca875-bb8a-49d5-8809-7121ba119381	2022-04-01	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
rexall all day allergy relief	CETIRIZINE HYDROCHLORIDE	Dolgencorp, LLC	4d79fb74-1895-4efe-8016-c0dd5ed10f7a	2021-06-01	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
basic care all day allergy	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	af8ff570-8f72-4343-b7e1-e977221f5b01	2021-04-09	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336

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
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	b33eb97f-5ac3-4eb7-b23a-cf550ce46287	5
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	b33eb97f-5ac3-4eb7-b23a-cf550ce46287	5
1014678	cetirizine HCl 10 MG Oral Tablet	SY	b33eb97f-5ac3-4eb7-b23a-cf550ce46287	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-458-48	49035045848	2 BOTTLE in 1 CARTON (49035-458-48) / 90 TABLET, FILM COATED in 1 BOTTLE	2 bottle	2012-03-02		No	No	Current
49035-458-51	49035045851	1 BOTTLE in 1 CARTON (49035-458-51) / 365 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2026-07-08		No	No	Current
49035-458-66	49035045866	14 BLISTER PACK in 1 CARTON (49035-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK	14 blister pack	2008-01-09	0000-00-00	No	No	Current
49035-458-75	49035045875	1 BOTTLE in 1 CARTON (49035-458-75) / 90 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2008-07-30	0000-00-00	No	No	Current
49035-458-87	49035045887	1 BOTTLE in 1 CARTON (49035-458-87) / 300 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-08-08	0000-00-00	No	No	Current
49035-458-95	49035045895	1 BOTTLE in 1 CARTON (49035-458-95) / 45 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2008-01-25	0000-00-00	No	No	Current