ZYRTEC HIVES

Product NDC: 50580-128
Requested package NDC: 50580-128-04
11-digit product format: 505800128
Labeler code: 50580
Product ID: 50580-128_37b3c47a-f31a-20f4-e063-6294a90ab07a
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Kenvue Brands LLC
Application: NDA022155
Marketing category: NDA
Marketing start: 2025-04-02
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 1 mg/mL
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022155-001	CHILDREN'S ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD, RS	2007-11-16
N022155-002	CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD, RS	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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	1 mg/mL

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
1014673	Internal RxNorm lookup
1020021	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
31400cb2-fe85-ef74-e063-6294a90a11fb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-128-04	ZYRTEC HIVES	1 in 1 CARTON	SOLUTION	1		2
50580-128-04	ZYRTEC HIVES	118 mL in 1 BOTTLE	SOLUTION	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-128	ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC]	1	Current NDC, 2 package rows	20250406_31400cb2-fe85-ef74-e063-6294a90a11fb.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
Childrens Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	2026-01-19	Warnings	Exact identifier application applno (NDA): 022155 application number: NDA022155
Childrens Zyrtec	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	9d8e78ea-af98-4f7c-8db5-044b49582f80	2025-10-10	Warnings	Exact identifier application applno (NDA): 022155 application number: NDA022155
ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	31400cb2-fe85-ef74-e063-6294a90a11fb	2025-06-16	Warnings	Exact identifier application applno (NDA): 022155 application number: NDA022155 ndc (package): 50580-128-04 ndc (product): 50580-128 ndc11 (package): 50580012804

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
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	31400cb2-fe85-ef74-e063-6294a90a11fb	2
1020021	ZyrTEC 5 MG in 5 mL Oral Solution	PSN	31400cb2-fe85-ef74-e063-6294a90a11fb	2
1020021	cetirizine hydrochloride 1 MG/ML Oral Solution [Zyrtec]	SBD	31400cb2-fe85-ef74-e063-6294a90a11fb	2
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	31400cb2-fe85-ef74-e063-6294a90a11fb	2
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	31400cb2-fe85-ef74-e063-6294a90a11fb	2
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	31400cb2-fe85-ef74-e063-6294a90a11fb	2
1020021	Children's Zyrtec 5 MG per 5 ML Medicated Spoon	SY	31400cb2-fe85-ef74-e063-6294a90a11fb	2
1020021	Zyrtec 1 MG/ML Oral Solution	SY	31400cb2-fe85-ef74-e063-6294a90a11fb	2
1020021	Zyrtec Children's 5 MG per 5 ML Syrup	SY	31400cb2-fe85-ef74-e063-6294a90a11fb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50580-128-04	50580012804	1 BOTTLE in 1 CARTON (50580-128-04) / 118 mL in 1 BOTTLE	1 bottle	2025-04-02	No	No	Current