FDA.reportPublic FDA data

NDC 80425-0489-03 - 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
80425-0489
Requested NDC
80425-0489-03
Package NDCs from labels
80425-0489-1, 80425-0489-3, 80425-0489-2, 80425-0489-4, 80425-0489-5, 80425-0489-03
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketorolac Tromethamine - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-01-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0489-1Ketorolac Tromethamine9 in 1 BOTTLETABLET, FILM COATED91
80425-0489-2Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED101
80425-0489-3Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED201
80425-0489-4Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED301
80425-0489-5Ketorolac Tromethamine60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0489KETOROLAC TROMETHAMINE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 5 package rows20250201_2cf7516b-ac86-ca72-e063-6394a90a4339.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0489-1EA - Each80425-0489b38a6c0a-008a-4e55-bd99-e2a9150e408b12025-03-04
80425-0489-2EA - Each80425-0489197e9d54-12dc-41d7-8981-94db5390ce8e12025-03-04
80425-0489-3EA - Each80425-0489a8041135-84a2-43be-bab8-fc2ee60fc7ea12025-03-04
80425-0489-4EA - Each80425-04895bb9bbbb-a4a1-4245-a676-71e6785ec4cf12025-03-04
80425-0489-5EA - Each80425-0489b4eaefe5-140e-45e6-b470-da643623ca7f12025-03-04

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 109 · 2,163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
ketorolac tromethamineKETOROLAC TROMETHAMINESportpharm LLC2a23b0fa-803c-4abb-b588-12cfe83326a92026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.6f727e1f-2838-427b-a236-eeb0101b08f32026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEREMEDYREPACK INC.cdd4d548-33f8-42d6-8eae-e36aa577c0502026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.04d5114e-332b-4ed0-85df-b276c1dc296c2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLC6758cb38-dec8-468f-94e2-613772e39b9a2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug59d86768-6214-8389-e063-6394a90a0a3d2026-08-25Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirst54dec321-b4c9-f0d6-e063-6294a90ae2312026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Ketorolac TromethamineKETOROLAC TROMETHAMINESportpharm LLC0749f61d-12e6-4280-8f41-bd4df81e7ae62026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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