Childrens Zyrtec Allergy

Product NDC: 50580-782
11-digit product format: 505800782
Labeler code: 50580
Product ID: 50580-782_327f7ae1-8b12-ef7a-e063-6294a90abd4a
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Kenvue Brands LLC
Application: NDA022578
Marketing category: NDA
Marketing start: 2014-01-20
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022578-001	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD, RS	2010-09-03

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 2 · 41 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	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022578-001	ZYRTEC ALLERGY	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2010-09-03	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Zyrtec 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1011482	Internal RxNorm lookup
1011485	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
a1edc2e6-3661-4d7a-884c-709d73cb89e0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-782-01	Childrens Zyrtec Allergy	4 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	4	11
50580-782-01	Childrens Zyrtec Allergy	2 in 1 PACKAGE	TABLET, ORALLY DISINTEGRATING	2	11
50580-782-12	Childrens Zyrtec Allergy	2 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	2	11
50580-782-12	Childrens Zyrtec Allergy	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6	11
50580-782-24	Childrens Zyrtec Allergy	4 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	4	11
50580-782-24	Childrens Zyrtec Allergy	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-782-12	EA - Each	50580-782	d60a4a70-3bfc-49cf-9f51-cb2b0d99feb1	1	2014-05-02
50580-782-24	EA - Each	50580-782	39e82ee7-6386-4086-b629-7f695f1a1175	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
Cetirizine	ACTIVE MOIETY	YO7261ME24	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
crospovidone	INACTIVE INGREDIENT	68401960MK	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer	INACTIVE INGREDIENT	905HNO1SIH	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
hydroxypropyl cellulose (type e)	INACTIVE INGREDIENT	66O7AQV0RT	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
mannitol	INACTIVE INGREDIENT	3OWL53L36A	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
sodium starch glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-782	CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [KENVUE BRANDS LLC]	11	Current NDC, Legacy NDC, 6 package rows	20250426_a1edc2e6-3661-4d7a-884c-709d73cb89e0.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 · 2 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	a1edc2e6-3661-4d7a-884c-709d73cb89e0	2025-04-22	Warnings	Exact identifier application applno (NDA): 022578 application number: NDA022578 ndc (product): 50580-782
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	6a962a1c-c197-492b-bfa6-e0c28eda1533	2025-04-11	Warnings	Exact identifier application applno (NDA): 022578 application number: NDA022578

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
1011482	cetirizine HCl 10 MG Disintegrating Oral Tablet	PSN	a1edc2e6-3661-4d7a-884c-709d73cb89e0	11
1011485	ZyrTEC 10 MG Disintegrating Oral Tablet	PSN	a1edc2e6-3661-4d7a-884c-709d73cb89e0	11
1011485	cetirizine hydrochloride 10 MG Disintegrating Oral Tablet [Zyrtec]	SBD	a1edc2e6-3661-4d7a-884c-709d73cb89e0	11
1011482	cetirizine hydrochloride 10 MG Disintegrating Oral Tablet	SCD	a1edc2e6-3661-4d7a-884c-709d73cb89e0	11
1011482	cetirizine HCl 10 MG Disintegrating Oral Tablet	SY	a1edc2e6-3661-4d7a-884c-709d73cb89e0	11
1011485	Zyrtec 10 MG Disintegrating Oral Tablet	SY	a1edc2e6-3661-4d7a-884c-709d73cb89e0	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-782-01	50580078201	2 CARTON in 1 PACKAGE (50580-782-01) / 4 BLISTER PACK in 1 CARTON / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2 carton	2014-01-20	0000-00-00	No	No	Current
50580-782-12	50580078212	2 BLISTER PACK in 1 CARTON (50580-782-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2 blister pack	2014-01-20	0000-00-00	No	No	Current
50580-782-24	50580078224	4 BLISTER PACK in 1 CARTON (50580-782-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	4 blister pack	2014-01-20	0000-00-00	No	No	Current