ZYRTEC

Product NDC
50580-779
11-digit product format
505800779
Labeler code
50580
Product ID
50580-779_cea20e63-c9ab-38c7-e053-2995a90adebe
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Application
NDA022429
Marketing category
NDA
Marketing start
2010-02-08
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50580-779DDiscontinued by firm2026-08-10
excluded packagepackage50580-77950580-779-12DDiscontinued by firm2026-08-10
excluded packagepackage50580-77950580-779-25DDiscontinued by firm2026-08-10
excluded packagepackage50580-77950580-779-40DDiscontinued by firm2026-08-10
excluded packagepackage50580-77950580-779-65DDiscontinued by firm2026-08-10

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50580-77950580-779-12DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50580-77950580-779-40DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50580-77950580-779-65DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022429-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGCAPSULE / ORALRLD2009-07-23
N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORALRLD, RS2009-07-23
N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MGCAPSULE / ORALRLD2009-07-23
N022429-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORALRLD, RS2009-07-23

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-23d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-779-12EA - Each50580-77955b1fc91-dfc4-4ca8-a5a1-405e3b8597d512012-07-24
50580-779-25EA - Each50580-77959492dd0-fb59-4646-b8f9-a56adc90fa0112012-07-24
50580-779-40EA - Each50580-7793e06abb1-99ed-408a-8c0e-493ed221146212012-07-24
50580-779-65EA - Each50580-77935e610c2-8d04-4dbc-b125-36130d20320612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOAZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]4
CetirizineACTIVE MOIETYYO7261ME24ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]4
gelatinINACTIVE INGREDIENT2G86QN327LZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]4
mannitolINACTIVE INGREDIENT3OWL53L36AZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]4
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32IZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]4
sorbitanINACTIVE INGREDIENT6O92ICV9RUZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]4
sorbitolINACTIVE INGREDIENT506T60A25RZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]4
waterINACTIVE INGREDIENT059QF0KO0RZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-779ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC]13Legacy NDC20241109_605adf29-734f-451a-8ff3-74be7b5814a6.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefCETIRIZINE HCLWhole Foods Market, INC.453b20b5-72a7-ac09-e063-6394a90afc4b2026-06-22WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLPUBLIX SUPER MARKETS INC4d652305-67f3-33f3-e063-6294a90a367e2026-06-22WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLAMERISOURCE BERGEN518ed897-7365-0520-e063-6394a90a06d62026-05-11WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLTOP CARE (Topco Associates LLC)3363bd32-cac6-e10c-e063-6294a90a26382026-05-11WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLMeijer Distribution Inc3143de16-2006-ec2e-e063-6294a90a1f672026-04-20WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLWALGREEN COMPANY4a181a38-ac94-8d00-e063-6394a90a6bf62026-04-20WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLBionpharma Inc.4fe8f764-a8e2-a432-e063-6294a90a33b02026-04-20WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLTARGET Corporation363845a9-c379-16a7-e063-6394a90a011a2026-04-20WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLKROGER COMPANY33f181f8-6e0d-b89b-e063-6394a90aeae72026-04-20WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLBionpharma Inc.2c2c4828-0479-4ff3-b2b0-dde5fa74efaf2025-12-16WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLTARGET Corporatione39a1a4f-c786-479a-9c11-aaf591810fe72025-12-16WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLKROGER COMPANY63ddeea4-d701-42b2-bcb7-81c0e43eb0132025-11-24WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLMeijer Distribution Inc235bf16e-4c23-95f8-e063-6394a90a62d52024-11-25WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLDOLGENCORP INC235c2640-8d6a-249d-e063-6394a90a132a2024-11-25WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLTOP CARE (Topco Associates LLC)2033e2c3-81af-b1cf-e063-6394a90adbc52024-11-22WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLPUBLIX SUPER MARKETS INC1ab5c526-b5fd-fca0-e063-6294a90ac54a2024-10-03WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
24 HOUR ALLERGYCETIRIZINE HCLWalgreensf3168f2c-27a7-4dd7-9770-e91443a580f12024-04-01WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Cetirizine HClCETIRIZINE HCLNortheast Pharma0647ef4c-8912-9f44-e063-6294a90ae3a62023-09-26WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
All Day Allergy ReliefCETIRIZINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.ec81dc4c-74c0-4719-be5d-686d545f40032022-12-29WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429
Allergy ReliefCETIRIZINE HCLDISCOUNT DRUG MART, INC.89c77f0d-a325-4f8f-9142-98c0d41de8b12022-12-29WarningsExact identifier
application applno (NDA): 022429
application number: NDA022429

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-779-12505800779121 BOTTLE in 1 PACKAGE (50580-779-12) > 12 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2010-02-080000-00-00NoNoCurrent
50580-779-25505800779251 BOTTLE in 1 PACKAGE (50580-779-25) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2010-02-080000-00-00NoNoCurrent
50580-779-40505800779401 BOTTLE in 1 PACKAGE (50580-779-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2010-02-080000-00-00NoNoCurrent
50580-779-655058007796565 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-779-65) 2010-02-080000-00-00NoNoCurrent