FDA.reportPublic FDA data

NDC 35418-751-67 - Zee Ibutab

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
35418-751
Requested NDC
35418-751-67
Package NDCs from labels
35418-751-02, 35418-751-68, 35418-751-67, 35418-751-69
Manufacturer
Zee Medical Inc | Ultra Seal Corporation
Effective date
2018-04-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zee Ibutab - Zee Medical Inc | Ultra Seal CorporationZee Medical Inc | Ultra Seal Corporation2018-04-15HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35418-751-692023-12-06C16284748780-1ba0f9c33-2d33-a910-e053-dadaa90a0b85Drug Facts
35418-751-692021-01-29C16284748780-1ba0f9c33-2d33-a910-e053-dadaa90a0b85Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZEE IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]2

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 192 · 3,832 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corpfc6c29b4-f1b3-4cfe-8c96-564d083be39c2026-07-24WarningsExact identifier
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
IbuprofenIBUPROFENTWIN MED LLCf03958f8-aeae-edf0-e053-2a95a90a3e9e2026-07-22WarningsExact identifier
application number: ANDA079174
unii: WK2XYI10QM
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: 532B59J990
Good Sense ibuprofenIBUPROFENL. Perrigo Companyaebae4b3-18c8-4ecf-b578-1fe7cc50076b2026-07-22WarningsExact identifier
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
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d82026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENCVS Pharmacy52193849-d03a-b61b-e063-6394a90ad2772026-07-20WarningsExact identifier
unii: WK2XYI10QM
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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