Zyrtec Allergy

Product NDC
50580-778
11-digit product format
505800778
Labeler code
50580
Product ID
50580-778_3254957b-3bb2-98a9-e063-6394a90a9358
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50580-77850580-778-12DDiscontinued by firm2026-08-11
excluded packagepackage50580-77850580-778-66DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0550580-778-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0550580-778-66d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2650580-778-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2650580-778-66f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3150580-778-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3150580-778-662ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2850580-778-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2850580-778-66a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2150580-778-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2150580-778-66cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1050580-778-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1050580-778-66cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3150580-778-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3150580-778-66302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2050580-778-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2050580-778-66ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1050580-778-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1050580-778-660efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0850580-778-66ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0850580-778-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0350580-778-66367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0350580-778-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0950580-778-66557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0950580-778-12557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022578-001ZYRTEC ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-033f01610625f2…
2019-09-15 20:21 UTC2019-09N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022578-001ZYRTEC ALLERGY10MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2010-09-03cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64O047KTOAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1011482Internal RxNorm lookup
1011485Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a962a1c-c197-492b-bfa6-e0c28eda1533Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-778-12Zyrtec Allergy2 in 1 CARTONTABLET, ORALLY DISINTEGRATING217
50580-778-12Zyrtec Allergy6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING617
50580-778-24Zyrtec Allergy4 in 1 CARTONTABLET, ORALLY DISINTEGRATING417
50580-778-24Zyrtec Allergy6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING617
50580-778-66Zyrtec Allergy11 in 1 CARTONTABLET, ORALLY DISINTEGRATING1117
50580-778-66Zyrtec Allergy6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING617

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-778-12EA - Each50580-778edad8f68-eb4b-4322-bdfe-ed5b565771ad12015-01-05
50580-778-24EA - Each50580-7785a2b0c49-f074-41a1-b5ac-abb39da000c412014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOAZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
CetirizineACTIVE MOIETYYO7261ME24ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
crospovidoneINACTIVE INGREDIENT68401960MKZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymerINACTIVE INGREDIENT905HNO1SIHZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
hydroxypropyl cellulose (type E)INACTIVE INGREDIENT66O7AQV0RTZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
magnesium stearateINACTIVE INGREDIENT70097M6I30ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
mannitolINACTIVE INGREDIENT3OWL53L36AZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-778ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [KENVUE BRANDS LLC]17Current NDC, Legacy NDC, 6 package rows20250413_6a962a1c-c197-492b-bfa6-e0c28eda1533.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLCa1edc2e6-3661-4d7a-884c-709d73cb89e02025-04-22WarningsExact identifier
application applno (NDA): 022578
application number: NDA022578
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLC6a962a1c-c197-492b-bfa6-e0c28eda15332025-04-11WarningsExact identifier
application applno (NDA): 022578
application number: NDA022578
ndc (product): 50580-778

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011482cetirizine HCl 10 MG Disintegrating Oral TabletPSN6a962a1c-c197-492b-bfa6-e0c28eda153317
1011485ZyrTEC 10 MG Disintegrating Oral TabletPSN6a962a1c-c197-492b-bfa6-e0c28eda153317
1011485cetirizine hydrochloride 10 MG Disintegrating Oral Tablet [Zyrtec]SBD6a962a1c-c197-492b-bfa6-e0c28eda153317
1011482cetirizine hydrochloride 10 MG Disintegrating Oral TabletSCD6a962a1c-c197-492b-bfa6-e0c28eda153317
1011482cetirizine HCl 10 MG Disintegrating Oral TabletSY6a962a1c-c197-492b-bfa6-e0c28eda153317
1011485Zyrtec 10 MG Disintegrating Oral TabletSY6a962a1c-c197-492b-bfa6-e0c28eda153317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-778-12505800778122 in 1 CARTONHistorical
50580-778-24505800778244 BLISTER PACK in 1 CARTON (50580-778-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 blister pack2014-01-200000-00-00NoNoCurrent
50580-778-665058007786611 in 1 CARTONHistorical