Berkley and Jensen Allergy Relief

Product NDC: 68391-500
11-digit product format: 683910500
Labeler code: 68391
Product ID: 68391-500_3a3dd69d-7cc9-43e7-9f2a-d04e7f923886
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: BJWC
Application: ANDA078336
Marketing category: ANDA
Marketing start: 2013-11-26
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68391-500		I	Inactivated by FDA	2026-10-15
excluded package	package	68391-500	68391-500-87	D	Discontinued by firm	2026-10-15
excluded package	package	68391-500	68391-500-88	I	Inactivated by FDA	2026-10-15

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 44.

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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078336-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078336-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
68391-500-87	2026-01-29	C162847	48780-1	49896155-b429-586f-e063-e6dba90add90	BJWC Allergy Relief Drug Facts
68391-500-88	2026-01-29	C162847	48780-1	49896155-b429-586f-e063-e6dba90add90	BJWC Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68391-500-87	Berkley and Jensen Allergy Relief	300 in 1 BOTTLE	TABLET, FILM COATED	300	5
68391-500-87	Berkley and Jensen Allergy Relief	1 in 1 PACKAGE	TABLET, FILM COATED	1	5
68391-500-88	Berkley and Jensen Allergy Relief	1 in 1 PACKAGE	TABLET, FILM COATED	1	5
68391-500-88	Berkley and Jensen Allergy Relief	365 in 1 BOTTLE	TABLET, FILM COATED	365	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]	2
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BJWC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68391-500	BERKLEY AND JENSEN ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [BJWC]	5	Legacy NDC, 4 package rows	20231129_caa22bcb-6617-4724-8dcb-e63bfeef41a9.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 3 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	198ca875-bb8a-49d5-8809-7121ba119381	2022-04-01	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
rexall all day allergy relief	CETIRIZINE HYDROCHLORIDE	Dolgencorp, LLC	4d79fb74-1895-4efe-8016-c0dd5ed10f7a	2021-06-01	Warnings	Exact identifier application applno (ANDA): 078336 application number: ANDA078336
basic care all day allergy	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	af8ff570-8f72-4343-b7e1-e977221f5b01	2021-04-09	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	caa22bcb-6617-4724-8dcb-e63bfeef41a9	5
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	caa22bcb-6617-4724-8dcb-e63bfeef41a9	5
1014678	cetirizine HCl 10 MG Oral Tablet	SY	caa22bcb-6617-4724-8dcb-e63bfeef41a9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68391-500-87	68391050087	300 in 1 BOTTLE						Historical
68391-500-88	68391050088	1 BOTTLE in 1 CARTON (68391-500-88) > 365 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2013-11-26	0000-00-00	No	No	Current