Equaline all day allergy

Product NDC: 41163-458
11-digit product format: 411630458
Labeler code: 41163
Product ID: 41163-458_6e7bab3d-af1a-4b74-921d-99aca2aa0fd3
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: United Natural Foods, Inc. dba UNFI
Application: ANDA078336
Marketing category: ANDA
Marketing start: 2008-01-23
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	41163-458	41163-458-58	D	Discontinued by firm	2026-08-03
excluded package	package	41163-458	41163-458-76	D	Discontinued by firm	2026-08-03
excluded package	package	41163-458	41163-458-95	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	41163-458-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41163-458-76	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41163-458-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	41163-458-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41163-458-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41163-458-76	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	41163-458-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	41163-458-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	41163-458-76	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	41163-458-95	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	41163-458-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	41163-458-76	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	41163-458-95	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	41163-458-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	41163-458-76	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	41163-458-95	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	41163-458-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	41163-458-76	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	41163-458-95	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	41163-458-58	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	41163-458-76	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	41163-458-95	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	41163-458-58	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	41163-458-76	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	41163-458-95	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	41163-458-58	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	41163-458-76	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	41163-458-95	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	41163-458-58	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	41163-458-76	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	41163-458-95	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	41163-458-58	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	41163-458-76	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	41163-458-95	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	41163-458-58	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	41163-458-76	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Equaline all day 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
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
491fae66-83b6-4beb-945b-39b9e4e021c5	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
41163-458-39	Equaline all day allergy	30 in 1 BOTTLE	TABLET, FILM COATED	30	9
41163-458-39	Equaline all day allergy	1 in 1 CARTON	TABLET, FILM COATED	1	9
41163-458-58	Equaline all day allergy	40 in 1 BOTTLE	TABLET, FILM COATED	40	9
41163-458-58	Equaline all day allergy	1 in 1 CARTON	TABLET, FILM COATED	1	9
41163-458-66	Equaline all day allergy	14 in 1 CARTON	TABLET, FILM COATED	14	9
41163-458-66	Equaline all day allergy	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	9
41163-458-72	Equaline all day allergy	1 in 1 CARTON	TABLET, FILM COATED	1	9
41163-458-72	Equaline all day allergy	60 in 1 BOTTLE	TABLET, FILM COATED	60	9
41163-458-76	Equaline all day allergy	120 in 1 BOTTLE	TABLET, FILM COATED	120	9
41163-458-76	Equaline all day allergy	1 in 1 CARTON	TABLET, FILM COATED	1	9
41163-458-95	Equaline all day allergy	1 in 1 PACKAGE	TABLET, FILM COATED	1	9
41163-458-95	Equaline all day allergy	45 in 1 BOTTLE	TABLET, FILM COATED	45	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41163-458-39	EA - Each	41163-458	efef2ed8-dbaa-45d0-9009-f7bf40a03c4f	1	2012-07-24
41163-458-66	EA - Each	41163-458	1145571e-187d-4c90-a65a-1d62af280cd6	1	2018-01-12
41163-458-72	EA - Each	41163-458	2a6ddf8f-b9c6-4a82-a203-f7c899db91d5	1	2012-07-24
41163-458-76	EA - Each	41163-458	88ebbce2-ff22-49c3-97cd-79bc0a95c089	1	2012-07-24
41163-458-95	EA - Each	41163-458	8ad88392-7fbb-4a48-8327-b6b3c2731a1a	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-458	EQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]	8	Current NDC, Legacy NDC, 12 package rows	20230803_491fae66-83b6-4beb-945b-39b9e4e021c5.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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health all day allergy	CETIRIZINE HYDROCHLORIDE	Dolgencorp Inc	b9ac489a-80ed-4077-b68e-d03df1b892a6	2026-07-28	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
allergy relief	CETIRIZINE HYDROCHLORIDE	H E B	8649fc1e-ad56-4660-bbbb-8f1ed795697b	2026-07-20	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Major Pharmaceuticals	71db132d-dca4-47ef-8560-c68ad2258933	2026-05-04	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
All Day Allergy	CETIRIZINE HYDROCHLORIDE	HyVee Inc	8889af37-8345-4358-994d-7d8b847f4874	2026-04-22	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Cardinal Health 107, LLC	37c6d1e4-dd88-42a2-a828-539b68aa5dad	2026-04-16	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Allergy Relief Indoor and Outdoor Allergies	CETIRIZINE HYDROCHLORIDE	CVS Pharmacy	98f3f2c6-da18-4055-81f1-962261360f9b	2026-03-31	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	7e158fd6-268d-4ffc-a410-d054090d54c5	2026-03-19	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
BERKLEY AND JENSEN ALL DAY ALLERGY	CETIRIZINE HYDROCHLORIDE	BJWC	b38c0068-5b06-4976-b68d-617bcc14f051	2026-02-11	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Major Pharmaceuticals	a5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a3	2026-01-29	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a462f9c0-45ef-49b1-b0d8-a02a75a4b731	2026-01-27	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Exchange select all day allergy	CETIRIZINE HYDROCHLORIDE	Army & Air Force Exchange Service	e7220494-3640-4b33-b577-ed3ca7c483e8	2026-01-15	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Good Sense all day allergy	CETIRIZINE HYDROCHLORIDE	L. Perrigo Company	2a7a27ab-1b4c-40d1-98bf-e4297aa25682	2026-01-08	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Northwind Health Company, LLC	f2b4d221-30ae-5a43-e053-2995a90a238a	2026-01-01	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
TopCare All Day Allergy	CETIRIZINE HYDROCHLORIDE	Topco Associates LLC	f2919aad-9ed4-40b8-b233-4aec06df33ea	2025-12-23	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Up and Up Allergy Relief	CETIRIZINE HYDROCHLORIDE	Target Corporation	ce93ca5b-2a65-4873-9686-926c44076c6c	2025-12-19	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	A-S Medication Solutions	ff782956-03b7-4ae6-b78f-fb7fe78b262d	2025-12-05	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4a45672b-67d3-4739-86ec-0a6696dd83d4	2025-12-04	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
signature care allergy relief	CETIRIZINE HYDROCHLORIDE	Safeway	24099cbf-61ee-4ec8-a4ec-95a66ceaa0c0	2025-12-04	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
GOODNOW ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Gobrands, Inc	86ade508-8841-47d8-addb-418ecd6dc8de	2025-11-07	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
Cetirizine	CETIRIZINE HYDROCHLORIDE	VERITYRX, LLC	43f40b92-f0e0-8808-e063-6394a90a656b	2025-10-30	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	491fae66-83b6-4beb-945b-39b9e4e021c5	9
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	491fae66-83b6-4beb-945b-39b9e4e021c5	9
1014678	cetirizine HCl 10 MG Oral Tablet	SY	491fae66-83b6-4beb-945b-39b9e4e021c5	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-458-39	41163045839	1 BOTTLE in 1 CARTON (41163-458-39) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2008-11-03	0000-00-00	No	No	Current
41163-458-58	41163045858	1 BOTTLE in 1 CARTON (41163-458-58) > 40 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-11-21	0000-00-00	No	No	Current
41163-458-66	41163045866	14 BLISTER PACK in 1 CARTON (41163-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK	14 blister pack	2008-01-23	0000-00-00	No	No	Current
41163-458-72	41163045872	1 BOTTLE in 1 CARTON (41163-458-72) / 60 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2009-09-09	0000-00-00	No	No	Current
41163-458-76	41163045876	1 BOTTLE in 1 CARTON (41163-458-76) > 120 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2009-08-05	0000-00-00	No	No	Current
41163-458-95	41163045895	1 in 1 PACKAGE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SuperValu Inc. All Day Allergy Drug Facts	United Natural Foods, Inc. dba UNFI	2025-09-18	HUMAN OTC DRUG LABEL	9