Childrens Zyrtec Allergy

Product NDC: 50580-721
Requested package NDC: 50580-721-05
11-digit product format: 505800721
Labeler code: 50580
Product ID: 50580-721_48bb7dd3-c2b8-ecfb-e063-6294a90af77d
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: Kenvue Brands LLC
Application: NDA022155
Marketing category: NDA
Marketing start: 2009-01-20
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 5 mg/5mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Childrens Zyrtec Allergy
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	5 mg/5mL

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
ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	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	Strength	SPL version
50580-721-05	Childrens Zyrtec Allergy	118 mL in 1 BOTTLE, PLASTIC	SYRUP	118		10
50580-721-05	Childrens Zyrtec Allergy	1 in 1 CARTON	SYRUP	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-721-04	ML - Milliliter	50580-721	f9512a1d-f76a-4184-baea-882afa736081	1	2015-10-02
50580-721-05	ML - Milliliter	50580-721	17d2c830-f0df-412d-9d9a-81798d1a957a	1	2017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
Cetirizine	ACTIVE MOIETY	YO7261ME24	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
sorbitol	INACTIVE INGREDIENT	506T60A25R	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
water	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-721	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [KENVUE BRANDS LLC]	8	Current NDC, Legacy NDC, 2 package rows	20250515_ee8695ac-1293-4e43-ac7c-a64e21a0ca0a.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 ndc (package): 50580-721-05 ndc (product): 50580-721 ndc11 (package): 50580072105
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

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	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	10
1020021	ZyrTEC 5 MG in 5 mL Oral Solution	PSN	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	10
1020021	cetirizine hydrochloride 1 MG/ML Oral Solution [Zyrtec]	SBD	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	10
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	10
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	10
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	10
1020021	Children's Zyrtec 5 MG per 5 ML Medicated Spoon	SY	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	10
1020021	Zyrtec 1 MG/ML Oral Solution	SY	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	10
1020021	Zyrtec Children's 5 MG per 5 ML Syrup	SY	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-721-05	50580072105	1 BOTTLE, PLASTIC in 1 CARTON (50580-721-05) / 118 mL in 1 BOTTLE, PLASTIC	2015-07-13	0000-00-00	No	No	Current