ALLERGY

Product NDC: 41226-692
Requested package NDC: 41226-692-14
11-digit product format: 412260692
Labeler code: 41226
Product ID: 41226-692_3e7fad54-62e1-6d0a-e063-6394a90a5785
Type: HUMAN OTC DRUG
Nonproprietary name: CETIRIZINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Kroger Company
Application: ANDA078933
Marketing category: ANDA
Marketing start: 2021-05-11
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: 2026-12-31
Current FDA listing: Yes

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
A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-06-15
A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-15
A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-06-15
A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-15

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	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: ALLERGY
Listing expiration: 2026-12-31

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
bc020340-ef39-e49a-e053-2a95a90af810	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
41226-692-14	ALLERGY	70 in 1 BOTTLE	TABLET, FILM COATED	70	5
41226-692-14	ALLERGY	2 in 1 CARTON	TABLET, FILM COATED	2	5
41226-692-65	ALLERGY	1 in 1 CARTON	TABLET, FILM COATED	1	5
41226-692-65	ALLERGY	365 in 1 BOTTLE	TABLET, FILM COATED	365	5
41226-692-70	ALLERGY	70 in 1 BOTTLE	TABLET, FILM COATED	70	5
41226-692-70	ALLERGY	1 in 1 CARTON	TABLET, FILM COATED	1	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41226-692	ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [KROGER COMPANY]	4	Current NDC, Legacy NDC, 6 package rows	20240605_bc020340-ef39-e49a-e053-2a95a90af810.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)	CETIRIZINE HYDROCHLORIDE	MARKSANS PHARMA LIMITED	652b0c65-a3f2-4454-9cf2-51a3389282cc	2026-07-10	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Cetirizine Hydrochloride Tablets,10 mg	CETIRIZINE HYDROCHLORIDE	Northwind Health Company, LLC	f756d3b1-d2e4-3705-e053-6294a90aa380	2026-01-01	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
ALLERGY	CETIRIZINE HYDROCHLORIDE	Kroger Company	bc020340-ef39-e49a-e053-2a95a90af810	2025-09-11	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933 ndc (package): 41226-692-14 ndc (product): 41226-692 ndc11 (package): 41226069214
Allergy Relief	CETIRIZINE HYDROCHLORIDE	BETTER LIVING BRANDS, LLC	eb60ae7d-87db-7413-e053-2a95a90afd76	2025-06-28	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Cetirizine Hydrochloride Tablets,10 mg	CETIRIZINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	d78223ba-80d5-47f8-e053-2a95a90aebdb	2024-03-06	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
All Day Allergy Relief	CETIRIZINE HYDROCHLORIDE	DOLGENCORP, INC.	0643ea78-9709-8526-e063-6394a90a227b	2023-12-15	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Allergy Relief	CETIRIZINE HYDROCHLORIDE	WALGREENS	f3c66f47-016a-799a-e053-2995a90ad424	2023-10-21	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	dfbddafb-9455-5805-e053-2a95a90ad0d9	2022-05-24	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933

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	bc020340-ef39-e49a-e053-2a95a90af810	5
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	bc020340-ef39-e49a-e053-2a95a90af810	5
1014678	cetirizine HCl 10 MG Oral Tablet	SY	bc020340-ef39-e49a-e053-2a95a90af810	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41226-692-14	41226069214	2 BOTTLE in 1 CARTON (41226-692-14) / 70 TABLET, FILM COATED in 1 BOTTLE	2 bottle	2021-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kroger Cetirizine Hydrochloride Tablets USP, 10 mg	Kroger Company \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2025-09-11	HUMAN OTC DRUG LABEL	5