FDA.reportPublic FDA data

Levocetirizine Dihydrochloride

Product NDC
50090-5341
11-digit product format
500905341
Labeler code
50090
Product ID
50090-5341_ec104719-030c-4cd3-bdf8-09e2ce339eb8
Type
HUMAN OTC DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213513
Marketing category
ANDA
Marketing start
2020-10-28
Marketing end
0000-00-00
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-5341IInactivated by FDA2026-07-31
excluded packagepackage50090-534150090-5341-0IInactivated by FDA2026-07-31
excluded packagepackage50090-534150090-5341-1IInactivated by FDA2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213513-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodmeds Levocetirizine Dihydrochloride 5mg 365 countLEVOCETIRIZINE DIHYDROCHLORIDE 5MGCabinet Health P.B.C.54f34304-952e-2f07-e063-6394a90a80ee2026-06-23WarningsExact identifier
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEFarmacias De Similares TX LLC4ed17484-5609-d993-e063-6294a90a82a22026-04-06WarningsExact identifier
Curist Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDE 5 MGLittle Pharma, Inc.f2a2a5bc-2efa-c550-e053-2a95a90a55ff2026-03-05WarningsExact identifier
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDESportpharm LLC8c00c74f-4377-4f2c-943e-e55afa5a824f2026-02-14Exact identifier
ALLERGY RELIEFLEVOCETIRIZINE DIHYDROCHLORIDEYYBA CORP8ee69332-742d-4071-95df-84bc42e170e72025-12-03WarningsExact identifier
Curist Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDE 5 MGLittle Pharma, Inc.feabf140-e283-dcd5-e053-6394a90a29172025-04-16WarningsExact identifier
Allery Relief 24HRALLERY RELIEF 24HRAllegiant Healthc523c210-b1c4-4049-9c72-2b31c9c931372024-04-02WarningsExact identifier
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECamber Consumer Care Incbe72dafb-62ae-40b2-874f-1d8920fad19d2020-11-30Exact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use If you have kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine Ask a doctor before use if you have ever had trouble urinating or emptying your bladder When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if have trouble urinating or emptying your bladder an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, if breast-feeding: not recommended if pregnant: ask a health professional before use

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5341-02023-01-30C16284748780-1f386c64a-328b-0266-e053-dadaa90a7c1aLevocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)
50090-5341-12023-01-30C16284748780-1f386c64a-328b-0266-e053-dadaa90a7c1aLevocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5341-0Levocetirizine Dihydrochloride30 in 1 BOTTLETABLET, FILM COATED303
50090-5341-1Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5341LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210417_3fad12b0-1bff-4899-99bb-0608b42d3be3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN3fad12b0-1bff-4899-99bb-0608b42d3be33
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD3fad12b0-1bff-4899-99bb-0608b42d3be33
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY3fad12b0-1bff-4899-99bb-0608b42d3be33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5341-05009053410030 TABLET, FILM COATED in 1 BOTTLE (50090-5341-0) 2020-11-040000-00-00NoNoCurrent
50090-5341-15009053410190 TABLET, FILM COATED in 1 BOTTLE (50090-5341-1) 2020-11-040000-00-00NoNoCurrent