FDA.reportPublic FDA data

baclofen 5 MG per 5 mL Oral Solution

RxCUI
250976
RxNorm name
baclofen 5 MG per 5 mL Oral Solution
Display name
baclofen 5 MG per 5 mL Oral Solution
Full name
baclofen 5 MG per 5 mL Oral Solution
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACLOFENBACLOFENTrifluent Pharma, LLC890df151-f4eb-4244-97c4-f1f10912e7532025-07-21Warnings, Adverse reactionsExact identifier
rxcui: 250976
BACLOFENBACLOFENAdvagen Pharma Ltd2a43830f-a28b-ca15-e063-6294a90a6b1a2025-06-12Warnings, Adverse reactionsExact identifier
rxcui: 250976

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
890df151-f4eb-4244-97c4-f1f10912e753baclofen 5 MG in 5 mL Oral Solution [PSN] · baclofen 1 MG/ML Oral Solution [SCD] · baclofen 5 MG per 5 mL Oral Solution [SY]32These highlights do not include all the information needed to use BACLOFEN ORAL SOLUTION safely and effectively. See full prescribing information for BACLOFEN ORAL SOLUTION. BACLOFEN oral solution Initial U.S. Approval: 197720250721
2a43830f-a28b-ca15-e063-6294a90a6b1abaclofen 5 MG in 5 mL Oral Solution [PSN] · baclofen 1 MG/ML Oral Solution [SCD] · baclofen 5 MG per 5 mL Oral Solution [SY]32These highlights do not include all the information needed to use BACLOFEN ORAL SOLUTION safely and effectively. See full prescribing information for BACLOFEN ORAL SOLUTION. BACLOFEN oral solution Initial U.S. Approval: 197720250612
6cc2773b-cb64-48e9-a69b-e457b82cb2d4baclofen 5 MG in 5 mL Oral Solution [PSN] · baclofen 1 MG/ML Oral Solution [SCD] · baclofen 5 MG per 5 mL Oral Solution [SY]32Baclofen Oral Solution These highlights do not include all the information needed to use Baclofen Oral Solution safely and effectively. See full prescribing information for Baclofen Oral Solution. Baclofen Oral Solution Initial U.S. Approval: 197720220328