CETIRIZINE HYDROCHLORIDE

Product NDC: 66116-417
11-digit product format: 661160417
Labeler code: 66116
Product ID: 66116-417_010ea8e3-4955-4332-8cca-f45977ab56c6
Type: HUMAN OTC DRUG
Nonproprietary name: CETIRIZINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: MedVantx, Inc.
Application: ANDA078862
Marketing category: ANDA
Marketing start: 2009-10-19
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66116-417		I	Inactivated by FDA		2026-08-03
excluded package	package	66116-417	66116-417-30	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66116-417-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66116-417-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66116-417-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66116-417-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66116-417-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66116-417-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66116-417-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66116-417-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66116-417-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66116-417-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66116-417-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66116-417-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66116-417-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66116-417-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66116-417-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66116-417-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	66116-417-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	66116-417-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66116-417-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66116-417-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	66116-417-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	66116-417-30	`110d247fa046…`	`a55b01930146…`

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
A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-02-19
A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-02-19
A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-02-19
A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-02-19

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	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`d06236e962d9…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66116-417-30	2019-11-27	C162847	48780-1	9855d018-d79c-cd31-e053-dbdaa90ab51a	010ea8e3-4955-4332-8cca-f45977ab56c6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66116-417-30	CETIRIZINE HYDROCHLORIDE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66116-417	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]	1	Legacy NDC, 1 package rows	20130823_010ea8e3-4955-4332-8cca-f45977ab56c6.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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE TABLETS	DISCOUNT DRUG MART, INC	4b9576dc-d7f9-dc10-e063-6294a90a233e	2026-04-23	Warnings	Exact identifier application applno (ANDA): 078862 application number: ANDA078862
Hives Relief	CETIRIZINE TABLETS	WALGREEN COMPANY	4526b65c-b0e7-180c-e063-6394a90ae916	2026-03-16	Warnings	Exact identifier application applno (ANDA): 078862 application number: ANDA078862
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Bionpharma Inc.	831d4141-b3be-4d98-a372-9c4d57ad296c	2025-12-08	Warnings	Exact identifier application applno (ANDA): 078862 application number: ANDA078862

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	010ea8e3-4955-4332-8cca-f45977ab56c6	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	010ea8e3-4955-4332-8cca-f45977ab56c6	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	010ea8e3-4955-4332-8cca-f45977ab56c6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66116-417-30	66116041730	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CETIRIZINE - MedVantx, Inc. \| Northstar Rx LLC \| Blenheim Pharmacal, Inc.	MedVantx, Inc. \| Northstar Rx LLC \| Blenheim Pharmacal, Inc.	2013-05-27	HUMAN OTC DRUG LABEL	1