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 8 of 57 · 1,137 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Ibuprofen Bubblegum Dye FreeIBUPROFENCVS2cf2f35b-5d66-e3ff-e063-6294a90a9b452026-06-16WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENGranules India Limited97516b9f-219a-429d-850d-1fe9fd66646b2026-06-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCardinal Health 110, LLC. DBA Leadera41a0bc2-ef7a-44cd-a42e-aefab41323cc2026-06-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENARMY AND AIR FORCE EXCHANGE SERVICE01f8fe3a-8810-4b38-8860-d95e05d377092026-06-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.2fa4bfc8-386c-433b-bc46-24fc8ec1bca12026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197807
unii: WK2XYI10QM
IbuprofenIBUPROFENNorthwind Health Company, LLCab80abe6-f7db-479b-e053-2a95a90a90e32026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197807
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.ec6b2df4-2f4f-4601-8b53-0542664e0bd92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197805
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.57b39311-bc20-ace6-75a9-a07a9311b3732026-06-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRite Aid Corporationd9e698f3-c450-4eaa-9cfd-6f48c26560812026-06-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENARMY AND AIR FORCE EXCHANGE SERVICE718a4b73-5f46-4676-afda-f0b4819f58622026-06-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION, INC.68988a5b-7a6a-4ecd-8006-f2610bac2ad72026-06-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENP & L Development, LLCd0301d0d-fc65-420f-87fd-a08da1584d542026-06-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAscend Laboratories, LLC9ce036ef-a22d-4fca-9a62-1b10978f7b262026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197805
rxcui: 197807
rxcui: 197806
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLC43c94480-78d1-4a23-91d4-1d49fea72cb72026-06-05WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen MinisIBUPROFENVivunt Pharma LLCc46803db-feb7-435c-ac42-cffa99d35f462026-06-04WarningsExact identifier
unii: WK2XYI10QM
dual actionACETAMINOPHEN, IBUPROFENPublix Super Markets Ince185d119-3484-40b1-afb8-6dca49d45e402026-06-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMedline industries, LP5d2482b4-cd90-4246-85a9-fd1d35315b6c2026-06-04WarningsExact identifier
unii: WK2XYI10QM
dual pain relieverACETAMINOPHEN, IBUPROFENMeijer, Inc.db1dc4f6-23ec-4a04-baa8-ffa739bce76a2026-06-04WarningsExact identifier
unii: WK2XYI10QM
DUAL ACTIONACETAMINOPHEN, IBUPROFENAmazon.com Services LLC20fe6b3f-e5a6-47d4-a371-9172408fbc462026-06-04WarningsExact identifier
unii: WK2XYI10QM
acetaminophen and ibuprofenACETAMINOPHEN, IBUPROFENKroger Companye6c0cca6-812e-4bea-86b0-e15b10f3f0d42026-06-04WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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