FDA.reportPublic FDA data

8 ML ibuprofen 100 MG/ML Injection

RxCUI
854183
RxNorm name
8 ML ibuprofen 100 MG/ML Injection
Display name
8 ML ibuprofen 100 MG/ML Injection
Full name
8 ML ibuprofen 100 MG/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

RxNav Current And Historical NDCs#

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

No records found.

UNII Substances#

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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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CaldolorIBUPROFENCumberland Pharmaceuticals Inc.1eaa7790-f1a1-4f51-b10a-cbbaf033f6842026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854183

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
1eaa7790-f1a1-4f51-b10a-cbbaf033f684ibuprofen 800 MG in 8 ML Injection [PSN] · 8 ML ibuprofen 100 MG/ML Injection [SCD] · ibuprofen 800 MG per 8 ML Injection [SY]316These highlights do not include all the information needed to use CALDOLOR ® safely and effectively. See full prescribing information for CALDOLOR. CALDOLOR (ibuprofen injection), for intravenous use Initial U.S. Approval: 197420250214