NDC 35418-750-67 - 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
35418-750
Requested NDC
35418-750-67
Package NDCs from labels
35418-750-02, 35418-750-68, 35418-750-67, 35418-750-69
Manufacturer
Zee Medical Inc | Ultra Seal Corporation
Effective date
2019-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibutab - Zee Medical Inc | Ultra Seal CorporationZee Medical Inc | Ultra Seal Corporation2019-10-01HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35418-750-692023-12-05C16284748780-1ba0f9c33-4776-a910-e053-dadaa90a0b85Drug Facts
35418-750-692021-01-29C16284748780-1ba0f9c33-4776-a910-e053-dadaa90a0b85Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]1

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 1 of 190 · 3,798 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: WK2XYI10QM
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENLidl US LLC0ca02f8b-4413-4e7c-a67b-8c67c53e13432026-09-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGOODSENSE596a1007-08ea-00ec-e063-6394a90a5eb22026-09-09WarningsExact identifier
unii: WK2XYI10QM
ibuprofen childrensIBUPROFENRite Aid Corporationc6e68886-edcb-414d-9cba-0d97772ef8b62026-09-09WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen minisIBUPROFENThe Kroger Co.15709fa7-114b-453c-b63d-f1c4f28f0f952026-09-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.2144eff0-d7ab-486d-b116-a4ff3ae2afe22026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENThe Kroger Co.a7789f7f-3356-463b-9fd7-2d7f7eba27992026-09-08WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLC90659e83-d989-46a5-9680-3a4f616125112026-09-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDirect_Rx40071818-5bf0-095b-e063-6294a90ad58a2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.8d518a08-486a-4d11-b042-27fc1e6060c92026-09-03WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN Immediate ReleaseIBUPROFENStrides Pharma Inca5dd275f-f388-44ec-8297-74430a742d522026-09-02Boxed warning, WarningsExact identifier
application number: ANDA079129
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0fa4cd66-66ad-4ec9-b38c-6b5840df39df2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen Immediate ReleaseIBUPROFENStrides Pharma Incebcc4da3-d0f6-4e40-99b5-e88310ea4a5b2026-09-02Boxed warning, WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.99730c4a-d2ee-46f5-91f4-a15cbaace40d2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3a38add6-a114-4e18-836c-3bfc727db2312026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.404df13d-4ada-4324-9eed-e21f5d5043a42026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corpfef89d3f-16e1-4a76-aabd-11d6eca4be862026-09-01WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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