Cetirizine HCL 10 mg All Day Allergy Relief

Product NDC: 55315-129
Requested package NDC: 55315-129-30
11-digit product format: 553150129
Labeler code: 55315
Product ID: 55315-129_c63e19f3-ecfa-45f5-bd6e-a67ff2c6ecb9
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Freds Inc
Application: ANDA078780
Marketing category: ANDA
Marketing start: 2013-03-01
Marketing end: 2021-12-30
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55315-129	55315-129-30	D	Discontinued by firm		2026-08-17

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 42.

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
A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-01-21
A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-01-21
A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-01-21
A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-01-21

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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078780-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078780-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2010-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078780-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2010-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078780-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-01-21	`d8e5a09893c0…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [FREDS INC]	2
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [FREDS INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [FREDS INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [FREDS INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [FREDS INC]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [FREDS INC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [FREDS INC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [FREDS INC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [FREDS INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [FREDS INC]	2

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 · 5 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	a042d98d-35ad-4d40-8b27-79dafd028096	2025-08-18	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780
Allergy Relief All Day	CETIRIZINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	27548729-7e2e-44cd-9a1d-70744f8b1df6	2025-07-01	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780
Cetirizine Hydrochloride Hives Relief	CETIRIZINE	Amneal Pharmaceuticals LLC	aad39214-5bf1-427b-a00e-410224c51c95	2024-10-23	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	214936a2-adc4-422a-a8fe-4c3ce9e01f36	2024-07-31	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780
Cetirizine Hydrochloride	CETIRIZINE	Amneal Pharmaceuticals LLC	273172b2-9aaf-46fb-a1ce-2961650eacd3	2024-07-31	Warnings	Exact identifier application applno (ANDA): 078780 application number: ANDA078780

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
64O047KTOA	CETIRIZINE HYDROCHLORIDE	83881-52-1	CETIRIZINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55315-129-30	55315012930	2 BLISTER PACK in 1 CARTON (55315-129-30) > 15 TABLET in 1 BLISTER PACK	2 blister pack	2013-03-01	2021-12-30	No	No	Current