Zero Allergy

Product NDC: 58593-827
Requested package NDC: 58593-827-14
11-digit product format: 585930827
Labeler code: 58593
Product ID: 58593-827_fe73cafa-ccf5-4659-9fc3-485825958f51
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Efficient Laboratories Inc
Application: ANDA077498
Marketing category: ANDA
Marketing start: 2013-04-01
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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	58593-827	58593-827-14	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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27
A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A077498-004	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	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-03-08	Drug Facts
2022-01-28	Drug Facts
2020-02-19	Drug Facts
2020-01-31	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES INC]	2
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES INC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES INC]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES INC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES INC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES 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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sportpharm LLC	357523b6-618b-4bff-a80d-c62e72a0804e	2026-05-08	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a7da81e1-8865-45c9-83c7-32fb8032ca2e	2026-03-19	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc	eb917099-fecf-6b55-e053-2995a90aaafa	2025-09-23	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	d0d8b376-9001-8776-e053-2a95a90ae651	2024-08-12	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	15eaa0d1-d18d-72b1-e063-6394a90a8a94	2024-04-12	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	d14feb90-3ca2-4d5b-825c-25fc2252ca38	2022-06-01	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Ohm Laboratories Inc.	161c4122-2c89-46e6-a6ae-db088087330d	2021-05-21	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	a0a063a1-e067-480e-afab-7f01165025f4	2019-08-19	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Chain Drug Consortium, LLC	9d7d2342-a594-4851-810b-b7bce1bd07dc	2018-08-24	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Valu Merchandisers Company	4a8d2887-8ac3-4d54-9e67-4a271d416426	2018-08-23	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Quality Choice Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Chain Drug Marketing Association Inc.	2e8cc4e3-8386-42de-801f-fef37f612849	2018-08-22	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Marc Glassman, Inc.	f30900e6-425f-43e0-81b6-1fa3bd321f0b	2018-06-20	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	LIDL US, LLC	a210d6b7-0829-4120-bb6d-fee0c2e57b26	2018-01-09	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	FAMILY DOLLAR SERVICES, INC	b326dacc-6123-47a7-9fde-6909db1d780b	2018-01-08	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498

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
58593-827-14	58593082714	14 TABLET in 1 BLISTER PACK (58593-827-14)	14 tablet	2013-04-01	0000-00-00	No	No	Current