FDA.reportPublic FDA data

NDC 80425-0089-01 - Ibuprofen

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
80425-0089
Requested NDC
80425-0089-01
Package NDCs from labels
80425-0089-4, 80425-0089-1, 80425-0089-2, 80425-0089-3, 80425-0089-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0089-1Ibuprofen30 in 1 BOTTLETABLET, FILM COATED3010
80425-0089-2Ibuprofen90 in 1 BOTTLETABLET, FILM COATED9010
80425-0089-3Ibuprofen120 in 1 BOTTLETABLET, FILM COATED12010
80425-0089-4Ibuprofen60 in 1 BOTTLETABLET, FILM COATED6010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0089IBUPROFEN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]10Current NDC, Legacy NDC, 4 package rows20250101_b33caad1-8d40-16f2-e053-2a95a90a1b2d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0089-1EA - Each80425-008901ce4c5e-17ef-4f4b-b965-568a87abebf112023-06-06
80425-0089-2EA - Each80425-00896ac60d16-43c1-486a-a4a2-aeae77dad7cb12023-06-06
80425-0089-3EA - Each80425-0089f137aff3-c81c-4c4d-ab0a-27b16fd37c1512023-06-06
80425-0089-4EA - Each80425-0089f74fc782-5cf4-468d-8455-425ded548afa12023-06-06

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 7 of 57 · 1,137 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dye-free pain reliefIBUPROFENBionpharma Inc.c46c9c36-8844-7b50-e053-2a95a90aa0e92026-06-23WarningsExact identifier
unii: WK2XYI10QM
dye-free pain reliefIBUPROFENBionpharma Inc.4227d0b7-846a-dcb0-e063-6294a90af7d72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.3c1c1b65-f57f-62b0-e063-6294a90a10212026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3802982a-2373-9ca3-e063-6394a90a0ab72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.4573753d-117b-a6f2-e063-6394a90ae2f92026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3ed7faff-fd48-0a83-e063-6394a90aab142026-06-23WarningsExact identifier
unii: WK2XYI10QM
Pain ReliefIBUPROFENAlbertsons Companiesf9deaeb7-efb3-4019-e053-6394a90a33d62026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.bc15fea8-0d86-4546-e053-2995a90abee32026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.a13ac87b-b395-685e-e053-2a95a90ab5d32026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWhole Foods Market, INC.32348505-744c-fbfd-e063-6394a90a82d72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERISOURCE BERGEN1afcf0c6-bd41-4621-9e44-d97b81221c122026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERISOURCE BERGENa13cee82-1c4e-0cbe-e053-2a95a90a3ab82026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions51de1183-d226-4869-a00a-f6c74e126a392026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197805
rxcui: 197807
rxcui: 197806
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions25a94943-9acc-49c8-a4da-7e07bb2c35eb2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197806
unii: WK2XYI10QM
IbuprofenIBUPROFENTopco Associates, LLC59a88ca7-eb37-46de-9134-a5a6d330bd492026-06-23WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx54d9e1fc-507d-1859-e063-6394a90a8c6b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCardinal Health 107, LLC8ea0e303-3967-4d71-8255-ac42a841ce282026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197805
rxcui: 197807
rxcui: 197806
unii: WK2XYI10QM
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC548c705e-4094-fc6f-e063-6394a90a34262026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.027ded51-aa01-6619-3938-c8162a421cf32026-06-18WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER06dd551b-6e13-425c-8d64-8d3177adc6bc2026-06-16WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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