FDA.reportPublic FDA data

NDC 55154-9366-05 - Ketorolac Tromethamine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55154-9366
Requested NDC
55154-9366-05
Package NDCs from labels
55154-9366-5, 55154-9366-05
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-08-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketorolac Tromethamine - Cardinal Health 107, LLCCardinal Health 107, LLC2026-08-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-9366-5Ketorolac Tromethamine1 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION19
55154-9366-5Ketorolac Tromethamine5 in 1 BAGINJECTION, SOLUTION59

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9366KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]8Current NDC, Legacy NDC, 2 package rows20240810_6758cb38-dec8-468f-94e2-613772e39b9a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-9366-5ML - Milliliter55154-93664bbeddfd-d426-4f97-8d04-6dcf6c0e270312017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]1

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 45 of 198 · 3,954 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINEDirect_rx22de8e1c-5e68-fd78-e063-6394a90ad40b2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665459
unii: 4EVE5946BQ
Sterillium comfortALCOHOLBODE Chemie GmbH2d48dab8-f70a-a2b5-e063-6294a90a14562026-03-16WarningsExact identifier
unii: 3K9958V90M
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b812c9-fb0a-5ee0-e063-6294a90a03e12026-03-16WarningsExact identifier
unii: 451W47IQ8X
Limited Edition Hand Sanitizer Pink Satin ProseccoALCOHOLScent Theory Products LLC4d278204-9331-aeb8-e063-6394a90a87a42026-03-16WarningsExact identifier
unii: 3K9958V90M
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b88e7c-eca0-5540-e063-6294a90a1b182026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b8c3f4-e528-c69d-e063-6294a90a5a342026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b7eb13-39c3-6f0e-e063-6394a90a40112026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8bb9c-d30f-152f-e063-6394a90a52082026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8dcbd-9e6b-1edc-e063-6394a90aac732026-03-16WarningsExact identifier
unii: 451W47IQ8X
Limited Edition Hand Sanitizer Cherry ChaiALCOHOLScent Theory Products LLC4d27a964-6e91-27c0-e063-6294a90ad9942026-03-16WarningsExact identifier
unii: 3K9958V90M
BM BIO20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFBM Private Limited4d285396-9df8-86bc-e063-6294a90ad4de2026-03-16WarningsExact identifier
unii: 451W47IQ8X
Sterillium FoamALCOHOLBODE Chemie GmbH93680cd8-609f-48f2-e053-2995a90aa3552026-03-16WarningsExact identifier
unii: 3K9958V90M
Sterillium rub fragrance-freeALCOHOLBODE Chemie GmbH2bc46854-fe65-782b-e063-6294a90a79af2026-03-16WarningsExact identifier
unii: 3K9958V90M
HealthWise Advanced Hand Sanitizer with LavenderETHYL ALCOHOL 70%Veridian Healthcare4d144fb3-b4b7-135f-e063-6394a90a366e2026-03-15WarningsExact identifier
unii: 3K9958V90M
HZ HPLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NITRICUM ACIDUM, RANUNCULUS BULBOSUS, RHUS TOX, SEPIA, THUJA OCCIDENTALISBioActive Nutritional, Inc.b662dea8-4eb5-4c80-a5ab-7d36887327732026-03-13WarningsExact identifier
unii: 451W47IQ8X
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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