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 9 of 192 · 3,832 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENREMEDYREPACK INC.b6a6c940-daf6-4e0e-aefb-35cce87a9a552026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.421156d2-85dc-4680-b2b4-d15b67539e872026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENBetter Living Brands, LLC45520969-7a2d-4469-ba25-7db160d50ccf2026-07-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.c0156053-add5-4bd5-b89f-f90df2e73be42026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENSelect Consumer Group55cd65fc-91bf-4979-e063-6294a90ab9b72026-07-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.20078671-536f-4b0b-a079-f90ac186a6702026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ADVILIBUPROFENSelect Consumer Group3ca752d8-957c-21b4-e063-6294a90a52852026-07-03WarningsExact identifier
unii: WK2XYI10QM
Advil LiquigelIBUPROFENSelect Consumer Group3ca6bc9d-090f-e412-e063-6394a90a68762026-07-03WarningsExact identifier
unii: WK2XYI10QM
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENProficient Rx LP34a9b94f-93ba-4a7c-92eb-d0b4b530d8872026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDr. Reddy's Laboratories Inc.4d830b9b-b396-9581-7572-c7f19ff175972026-07-01WarningsExact identifier
application number: ANDA079174
unii: WK2XYI10QM
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENSt. Mary's Medical Park Pharmacy88dd304f-1c64-08e3-e053-2a95a90a596f2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLCfaabb11a-6fa0-492d-85cc-74ff8175b0b32026-07-01WarningsExact identifier
unii: WK2XYI10QM
Infants MotrinIBUPROFENKenvue Brands LLCc2302bfe-b367-4867-b803-29f066a42dc72026-06-30WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.1e6f3ce7-e8a3-40e8-8437-523ef5277b2e2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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