Zyrtec Allergy

Product NDC: 50580-754
Requested package NDC: 50580-754-35
11-digit product format: 505800754
Labeler code: 50580
Product ID: 50580-754_3a6e2ec1-eab8-beec-e063-6394a90aa39c
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Kenvue Brands LLC
Application: NDA019835
Marketing category: NDA
Marketing start: 2025-02-15
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 5 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 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	RLD / RS	Approval date
N019835-003	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	2007-11-16
N019835-004	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RLD, RS	2007-11-16
N019835-005	ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	2007-11-16
N019835-006	ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RLD	2007-11-16

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	5 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1014676	Internal RxNorm lookup
1014677	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
2c1ecee3-c2c1-25a2-e063-6294a90aad54	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
50580-754-15	Zyrtec Allergy	15 in 1 CARTON	TABLET, FILM COATED	15	3
50580-754-15	Zyrtec Allergy	1 in 1 POUCH	TABLET, FILM COATED	1	3
50580-754-35	Zyrtec Allergy	35 in 1 BOTTLE	TABLET, FILM COATED	35	3
50580-754-35	Zyrtec Allergy	1 in 1 CARTON	TABLET, FILM COATED	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-754	ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]	1	Current NDC, 4 package rows	20250216_2c1ecee3-c2c1-25a2-e063-6294a90aad54.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Select Consumer Group	568960cf-2c8f-f1b0-e063-6294a90aebc7	2026-07-13	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Savings Distributors LLC	5490c38a-91d7-9ee1-e063-6394a90a1ea5	2026-06-01	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	b165db38-b302-4220-8627-77cb07bb078c	2025-10-10	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	6685a843-9dbe-4f9e-b75b-fe0e258f4155	2025-10-08	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	2c1ecee3-c2c1-25a2-e063-6294a90aad54	2025-07-21	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835 ndc (package): 50580-754-35 ndc (product): 50580-754 ndc11 (package): 50580075435
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Morning Star OTC	3efa421d-ea70-4b1f-95d0-7c63b6c39580	2025-06-19	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
ZYRTEC Hives	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	31136e3a-94fa-0860-e063-6394a90a008d	2025-06-16	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	RedPharm Drug Inc	f4c1f9fd-2d32-71d3-e053-2a95a90a3ba4	2025-01-23	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec 1s Blister	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	3a595eb8-2409-4598-8704-ab59b57bd062	2024-12-31	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec 2s Blister	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	af0ba7b0-b511-9f81-e053-2a95a90ade2c	2024-12-31	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc	a4146629-57f0-42e0-b905-df364a8a99f5	2024-12-31	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy, Lil Drug Store	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED	Lil' Drug Store Products, Inc.	1b6c945f-591f-8869-e063-6294a90ad397	2024-06-21	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Navajo Manufacturing Company Incorporated	9c4693cb-f066-0666-e053-2a95a90a96d3	2023-03-16	Warnings	Exact identifier application applno (NDA): 019835 application number: NDA019835

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
1014676	cetirizine HCl 5 MG Oral Tablet	PSN	2c1ecee3-c2c1-25a2-e063-6294a90aad54	3
1014677	ZyrTEC 5 MG Oral Tablet	PSN	2c1ecee3-c2c1-25a2-e063-6294a90aad54	3
1014677	cetirizine hydrochloride 5 MG Oral Tablet [Zyrtec]	SBD	2c1ecee3-c2c1-25a2-e063-6294a90aad54	3
1014676	cetirizine hydrochloride 5 MG Oral Tablet	SCD	2c1ecee3-c2c1-25a2-e063-6294a90aad54	3
1014677	Zyrtec (cetirizine dihydrochloride 5 MG) Oral Tablet	SY	2c1ecee3-c2c1-25a2-e063-6294a90aad54	3
1014677	Zyrtec 5 MG Oral Tablet	SY	2c1ecee3-c2c1-25a2-e063-6294a90aad54	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50580-754-35	50580075435	1 BOTTLE in 1 CARTON (50580-754-35) / 35 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2025-02-15	No	No	Current