FDA.reportPublic FDA data

NDC 80425-0046-01 - 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
80425-0046
Requested NDC
80425-0046-01
Package NDCs from labels
80425-0046-3, 80425-0046-1, 80425-0046-2, 80425-0046-4, 80425-0046-5, 80425-0046-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-08-07
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, LLC2025-08-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0046-1Ibuprofen90 in 1 BOTTLETABLET, FILM COATED9010
80425-0046-2Ibuprofen120 in 1 BOTTLETABLET, FILM COATED12010
80425-0046-3Ibuprofen60 in 1 BOTTLETABLET, FILM COATED6010
80425-0046-4Ibuprofen30 in 1 BOTTLETABLET, FILM COATED3010
80425-0046-5Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0046IBUPROFEN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 5 package rows20250101_af9ac948-440c-5abf-e053-2995a90af2b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0046-1EA - Each80425-004662581d8b-2f74-46b8-863f-a79f6a44d7a512023-06-06
80425-0046-2EA - Each80425-0046155f2633-4c11-401d-b550-262b6ca9e2c512023-06-06
80425-0046-3EA - Each80425-00464fdfb716-6522-430f-a2ba-d234476a568612023-06-06
80425-0046-4EA - Each80425-0046c97f3641-cd80-4bf6-9b61-25a0bd8be5a912023-06-06
80425-0046-5EA - Each80425-00464b9256f5-33f7-42a3-86fb-30d523c705b612025-09-12

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 6 of 57 · 1,137 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENHAWAII REPACK, INC.6239818c-747d-4cbb-9b41-27ca8bbce41b2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197805
rxcui: 197807
rxcui: 197806
unii: WK2XYI10QM
IbuprofenIBUPROFENSportpharm LLCcef04ae4-e78a-454d-bb66-84b1d348c1062026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197805
rxcui: 197807
rxcui: 197806
unii: WK2XYI10QM
Ibuprofen mini dye freeIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.552d9018-cc7e-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)fb842f4d-1228-9a52-e053-6294a90adb412026-06-26WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENUnit Dose Solutions, Inc.551535ce-eab0-bb13-e063-6294a90a20702026-06-25WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENUnit Dose Solutions, Inc.5515661b-6373-2191-e063-6294a90a17e02026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091625
rxcui: 197806
unii: WK2XYI10QM
IbuprofenIBUPROFENUnit Dose Solutions, Inc.5515e80f-7513-b425-e063-6294a90aa5422026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197807
unii: WK2XYI10QM
Ibuprofen Mini Dye FreeIBUPROFENCVS Pharmacy42c7dbec-2e53-70ae-e063-6294a90a16e62026-06-25WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutionsb40f39e4-a37c-4039-ae37-210c1c3c62352026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091625
rxcui: 197806
unii: WK2XYI10QM
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)c62cc12f-5a0e-389a-e053-2995a90a208c2026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)c6297c23-3b27-c0c6-e053-2995a90a3e762026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.a139e495-3dbf-4998-e053-2a95a90ac1362026-06-23WarningsExact identifier
unii: WK2XYI10QM
pain reliefIBUPROFENBionpharma Inc.a14ca126-fada-c903-e053-2995a90ae72d2026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHEBca4be24c-5d92-ddc9-e053-2a95a90aa5a72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDOLGENCORP INC03138a6f-653a-f359-e063-6394a90ac5d62026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFEN CAPSULEPUBLIX SUPER MARKETS INC10a6eba7-e400-ce97-e063-6294a90af3bd2026-06-23WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENDISCOUNT DRUG MART, INC.d07ea9e3-88b0-4aa0-903a-10555dcca37d2026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDISCOUNT DRUG MART, INC.aae40114-343e-12da-e053-2a95a90a92132026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBJWC0ca0b6cf-7d1f-4673-b9b9-48f78d80c00a2026-06-23WarningsExact identifier
unii: WK2XYI10QM
pain reliefIBUPROFENBionpharma Inc.2b4ecdd8-627a-445f-8ddc-f2b6c832c1e82026-06-23WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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