FDA.reportPublic FDA data

NDC 70000-0176-01 - Leader 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
70000-0176
Requested NDC
70000-0176-01
Package NDCs from labels
70000-0176-3, 70000-0176-1, 70000-0176-2, 70000-0176-5, 70000-0176-4, 70000-0176-6, 70000-0176-01
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leader Ibuprofen - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2025-08-14HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0176-1Leader Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1009
70000-0176-1Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19
70000-0176-2Leader Ibuprofen200 in 1 BOTTLETABLET, FILM COATED2009
70000-0176-2Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19
70000-0176-3Leader Ibuprofen250 in 1 BOTTLETABLET, FILM COATED2509
70000-0176-3Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19
70000-0176-4Leader Ibuprofen50 in 1 BOTTLETABLET, FILM COATED509
70000-0176-4Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19
70000-0176-5Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19
70000-0176-5Leader Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5009
70000-0176-6Leader Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1209
70000-0176-6Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0176LEADER IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]8Current NDC, Legacy NDC, 12 package rows20230801_63b8d389-7feb-41d2-8970-b7d5660ccb4a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0176-1EA - Each70000-0176ee84ee46-ac9f-4abf-8051-c77864fe20d912018-06-11
70000-0176-2EA - Each70000-0176211e658b-111b-4c66-85b9-1197851227a712019-06-19
70000-0176-3EA - Each70000-01764c7e75ca-0627-4d04-8a00-585212b9415412018-11-06
70000-0176-4EA - Each70000-017601635ad2-bfbd-4de8-b0b0-729a2ec0d31212019-05-02
70000-0176-5EA - Each70000-01767563d36d-1451-4b46-acdd-174335fe72fc12017-12-14
70000-0176-6EA - Each70000-01768743f02d-4232-41a9-bc80-f787cde2cc6112018-03-08

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 193 · 3,843 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL MIGRAINEIBUPROFENHaleon US Holdings LLCe4a6219d-4ad4-0119-4cf8-7fc39b4b59792026-07-29WarningsExact identifier
unii: WK2XYI10QM
AdvilIBUPROFENHaleon US Holdings LLC1f01c10a-9434-91a4-2ee4-352315a6b6102026-07-29WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAscend Laboratories, LLC4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENH E B21567c0f-abba-4a40-a0b9-5ce49b3d96482026-07-28WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.656658cc-8cf0-42b6-af4f-4e3ab76486252026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.a7756b22-73cf-4262-aa8e-0577ddecd03b2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corp1ca722bb-940e-4b3e-9561-d87e2feb1ff82026-07-24WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corpfc6c29b4-f1b3-4cfe-8c96-564d083be39c2026-07-24WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
childrens ibuprofenIBUPROFENRite Aid Corporation26bccfc1-bc8d-4241-a078-c760048951c92026-07-24WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHF Acquisition Co LLC, DBA HealthFirst574b6f15-70bc-fca7-e063-6294a90a04552026-07-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSafeway, Inc.a530d43d-e9c4-4edb-af66-c92860e46f452026-07-23WarningsExact identifier
unii: WK2XYI10QM
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
IbuprofenIBUPROFENTWIN MED LLCf03958f8-aeae-edf0-e053-2a95a90a3e9e2026-07-22WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Good Sense ibuprofenIBUPROFENL. Perrigo Companyaebae4b3-18c8-4ecf-b578-1fe7cc50076b2026-07-22WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.d3a7ebef-f7ab-4b34-b62e-278a8deabf782026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.b81c6495-8b30-41ef-8a0f-4cbfd87f1eb42026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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