FDA.reportPublic FDA data

levocetirizine dihydrochloride 0.5 MG/ML Oral Solution

RxCUI
855168
RxNorm name
levocetirizine dihydrochloride 0.5 MG/ML Oral Solution
Display name
levocetirizine dihydrochloride 0.5 MG/ML Oral Solution
Full name
levocetirizine dihydrochloride 0.5 MG/ML Oral Solution
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Xyzal AllergyLEVOCETIRIZINE DIHYDROCHLORIDEChattem, Inc.a33f2704-d350-428b-b467-91f4775ce17f2026-02-05WarningsExact identifier
rxcui: 855168
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd2965ef46-18db-4615-9dce-bfb0f0b3366a2025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 855168
XyzalLEVOCETIRIZINE DIHYDROCHLORIDEChattem, Inc.1673f7ff-0c7c-4403-86cf-c05eb14752222025-07-22Warnings, Adverse reactionsExact identifier
rxcui: 855168
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECamber Pharmaceuticals, Inc.dc8adb01-a7ca-490b-b476-8915f1a2e6db2025-06-12Warnings, Adverse reactionsExact identifier
rxcui: 855168
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack628c26f0-f6bb-4658-ba50-8ca04cd859cb2024-07-10Warnings, Adverse reactionsExact identifier
rxcui: 855168
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEChartwell RX, LLCb56652ad-2cf8-4ed0-bb66-0e832772c7922023-10-12Warnings, Adverse reactionsExact identifier
rxcui: 855168
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepacka9e7152c-0aa3-4355-8805-307e510ac86b2023-09-26Warnings, Adverse reactionsExact identifier
rxcui: 855168

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 9 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
628c26f0-f6bb-4658-ba50-8ca04cd859cblevocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution [PSN] · levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [SCD] · levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution [SY]3108These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION. LEVOCETIRIZINE DIHYDROCHLORIDE oral solution Initial U.S. Approval: 199520240710
a9e7152c-0aa3-4355-8805-307e510ac86blevocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution [PSN] · levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [SCD] · levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution [SY]3100These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION. LEVOCETIRIZINE DIHYDROCHLORIDE oral solution Initial U.S. Approval: 199520230926
a33f2704-d350-428b-b467-91f4775ce17flevocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution [PSN] · levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [SCD] · levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution [SY]322Childrens Xyzal Allergy20260121
2965ef46-18db-4615-9dce-bfb0f0b3366alevocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution [PSN] · levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [SCD] · levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution [SY]318These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION. LEVOCETIRIZINE DIHYDROCHLORIDE oral solution Initial U.S. Approval: 199520250731
dc8adb01-a7ca-490b-b476-8915f1a2e6dblevocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution [PSN] · levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [SCD] · levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution [SY]34These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION. LEVOCETIRIZINE DIHYDROCHLORIDE oral solution Initial U.S. Approval: 199520250612
1673f7ff-0c7c-4403-86cf-c05eb1475222levocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution [PSN] · levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [SCD] · levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution [SY]32These highlights do not include all the information needed to use XYZAL ® safely and effectively. See full prescribing information for XYZAL. XYZAL (levocetirizine dihydrochloride) tablets, for oral use XYZAL (levocetirizine dihydrochloride) oral solution Initial U.S. Approval: 199520250722
b56652ad-2cf8-4ed0-bb66-0e832772c792levocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution [PSN] · levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [SCD] · levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution [SY]32These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION. LEVOCETIRIZINE DIHYDROCHLORIDE oral solution Initial U.S. Approval: 199520231012
ef55e23c-731a-341c-e053-2995a90a0bf3levocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution [PSN] · levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [SCD] · levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution [SY]31These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION. LEVOCETIRIZINE DIHYDROCHLORIDE oral solution Initial U.S. Approval: 199520221208
371ca86d-7ffd-4f20-b6c6-af0a9ff7362flevocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution [PSN] · levocetirizine dihydrochloride 0.5 MG/ML Oral Solution [SCD] · levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution [SY]31These highlights do not include all the information needed to use XYZAL safely and effectively. See full prescribing information for XYZAL. XYZAL (levocetirizine dihydrochloride) 5 mg tablets 2.5 mg/5 mL (0.5 mg/mL) oral solution Initial U.S. Approval: 199520100511