Allergy Relief

Product NDC: 59779-458
Requested package NDC: 59779-458-58
11-digit product format: 597790458
Labeler code: 59779
Product ID: 59779-458_131dd209-e1fe-4dd4-9523-8c0da50b78f4
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CVS Pharmacy
Application: ANDA078336
Marketing category: ANDA
Marketing start: 2009-01-14
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

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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: Allergy Relief
Brand name suffix: Indoor and Outdoor Allergies
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
98f3f2c6-da18-4055-81f1-962261360f9b	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
59779-458-00	Allergy ReliefIndoor and Outdoor Allergies	1 in 1 CARTON	TABLET, FILM COATED	1	14
59779-458-00	Allergy ReliefIndoor and Outdoor Allergies	60 in 1 BOTTLE	TABLET, FILM COATED	60	14
59779-458-01	Allergy ReliefIndoor and Outdoor Allergies	2 in 1 CARTON	TABLET, FILM COATED	2	14
59779-458-05	Allergy ReliefIndoor and Outdoor Allergies	90 in 1 BOTTLE	TABLET, FILM COATED	90	14
59779-458-06	Allergy ReliefIndoor and Outdoor Allergies	70 in 1 BOTTLE	TABLET, FILM COATED	70	14
59779-458-06	Allergy ReliefIndoor and Outdoor Allergies	1 in 1 CARTON	TABLET, FILM COATED	1	14
59779-458-13	Allergy ReliefIndoor and Outdoor Allergies	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	14
59779-458-13	Allergy ReliefIndoor and Outdoor Allergies	5 in 1 CARTON	TABLET, FILM COATED	5	14
59779-458-39	Allergy ReliefIndoor and Outdoor Allergies	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
59779-458-39	Allergy ReliefIndoor and Outdoor Allergies	1 in 1 CARTON	TABLET, FILM COATED	1	14
59779-458-58	Allergy ReliefIndoor and Outdoor Allergies	1 in 1 CARTON	TABLET, FILM COATED	1	14
59779-458-58	Allergy ReliefIndoor and Outdoor Allergies	40 in 1 BOTTLE	TABLET, FILM COATED	40	14
59779-458-66	Allergy ReliefIndoor and Outdoor Allergies	14 in 1 CARTON	TABLET, FILM COATED	14	14
59779-458-66	Allergy ReliefIndoor and Outdoor Allergies	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	14
59779-458-70	Allergy ReliefIndoor and Outdoor Allergies	2 in 1 CARTON	TABLET, FILM COATED	2	14
59779-458-70	Allergy ReliefIndoor and Outdoor Allergies	120 in 1 BOTTLE	TABLET, FILM COATED	120	14
59779-458-72	Allergy ReliefIndoor and Outdoor Allergies	2 in 1 CARTON	TABLET, FILM COATED	2	14
59779-458-72	Allergy ReliefIndoor and Outdoor Allergies	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
59779-458-75	Allergy ReliefIndoor and Outdoor Allergies	90 in 1 BOTTLE	TABLET, FILM COATED	90	14
59779-458-75	Allergy ReliefIndoor and Outdoor Allergies	1 in 1 CARTON	TABLET, FILM COATED	1	14
59779-458-76	Allergy ReliefIndoor and Outdoor Allergies	1 in 1 CARTON	TABLET, FILM COATED	1	14
59779-458-76	Allergy ReliefIndoor and Outdoor Allergies	120 in 1 BOTTLE	TABLET, FILM COATED	120	14
59779-458-88	Allergy ReliefIndoor and Outdoor Allergies	365 in 1 BOTTLE	TABLET, FILM COATED	365	14
59779-458-88	Allergy ReliefIndoor and Outdoor Allergies	1 in 1 CARTON	TABLET, FILM COATED	1	14
59779-458-95	Allergy ReliefIndoor and Outdoor Allergies	1 in 1 CARTON	TABLET, FILM COATED	1	14
59779-458-95	Allergy ReliefIndoor and Outdoor Allergies	45 in 1 BOTTLE	TABLET, FILM COATED	45	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-458-06	EA - Each	59779-458	25de9fff-facc-4a33-bb36-0e59f1118cae	1	2018-11-06
59779-458-13	EA - Each	59779-458	341cf740-7f51-4ccf-a90f-3839cb396d72	1	2018-11-06
59779-458-39	EA - Each	59779-458	8872285d-8fd8-41ee-89b0-3f81756420cb	1	2018-10-11
59779-458-66	EA - Each	59779-458	2ee9b5da-ac29-4344-bf68-fdc7b0667770	1	2018-11-06
59779-458-70	EA - Each	59779-458	eef30a01-286c-4ccd-b28f-e59565ca5556	1	2018-11-06
59779-458-72	EA - Each	59779-458	9bd043f2-ba27-42bd-9691-cb333cdd4444	1	2022-06-06
59779-458-75	EA - Each	59779-458	c68f1359-ac9d-42b4-bb63-9fdbba56eb3f	1	2018-10-11
59779-458-76	EA - Each	59779-458	5918cdf4-9b70-4108-baae-1d494cbefc60	1	2018-10-11
59779-458-88	EA - Each	59779-458	53c52fdd-9771-4c22-b05e-7e61475e8931	1	2017-03-06
59779-458-95	EA - Each	59779-458	d819536e-bd42-4b1d-91fc-f6a414652f6b	1	2018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	5
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-458	ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY]	11	Current NDC, Legacy NDC, 26 package rows	20230115_98f3f2c6-da18-4055-81f1-962261360f9b.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 ndc (package): 59779-458-58 ndc (product): 59779-458 ndc11 (package): 59779045858
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	98f3f2c6-da18-4055-81f1-962261360f9b	14
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	98f3f2c6-da18-4055-81f1-962261360f9b	14
1014678	cetirizine HCl 10 MG Oral Tablet	SY	98f3f2c6-da18-4055-81f1-962261360f9b	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-458-58	59779045858	1 BOTTLE in 1 CARTON (59779-458-58) / 40 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2014-03-21	0000-00-00	No	No	Current