FDA.reportPublic FDA data

NDC 51672-2144-01 - 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
51672-2144
Requested NDC
51672-2144-01
Package NDCs from labels
51672-2144-8, 51672-2144-1, 51672-2144-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IbuprofenSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-07HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2144-1Ibuprofen240 mL in 1 BOTTLESUSPENSION2405
51672-2144-1Ibuprofen1 in 1 CARTONSUSPENSION15
51672-2144-8Ibuprofen120 mL in 1 BOTTLESUSPENSION1205
51672-2144-8Ibuprofen1 in 1 CARTONSUSPENSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2144IBUPROFEN SUSPENSION [-SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 4 package rows20250406_6cf3328b-da8f-4f6b-8237-16a4d6b9c833.zip

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 60 of 87 · 1,738 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spleenex VHARALIA QUINQUEFOLIA, GINKGO BILOBA, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, NICCOLUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, BARYTA CARBONICA, PHOSPHORICUM ACIDUM, ACONITICUM ACIDUM, CIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.54e2c88e-2483-4c38-86e5-19e218e713ae2024-10-30WarningsExact identifier
unii: XF417D3PSL
Spleenex VARALIA QUINQUEFOLIA, POTASSIUM GLUCONATE, GINKGO BILOBA, MAGNESIUM GLUCONICUM DIHYDRICUM, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ACONITICUM ACIDUM, CIS-, NATRUM OXALACETICUMEnergique, Inc.effbaa07-239b-42f2-afd4-0eeeba7de1fd2024-10-30WarningsExact identifier
unii: XF417D3PSL
Ibuprofen and Diphenhydramine CitrateIBUPROFEN AND DIPHENHYDRAMINE CITRATEBetter Living Brands, LLCfcfb044d-f6b9-5c43-e053-6394a90ac4172024-10-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepack7650f84b-92f2-4065-8ef2-f5de5bd7002b2024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
LactistatARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, GRAPHITES, HYDROFLUORICUM ACIDUM, LACHESIS MUTUS, LACTICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SACCHARUM OFFICINALEEnergique, Inc.8dcc4a3a-9f21-4a77-ae42-b2c8283a076a2024-10-28WarningsExact identifier
unii: C151H8M554
IbuprofenIBUPROFENBryant Ranch Prepack1361b6d6-0443-460a-8446-41f63a1e28df2024-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRugby Laboratories, Inc.05c4e6c7-bf95-4e05-b7da-7a8778de342b2024-10-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb619068-be71-7569-e053-2a95a90a4a6e2024-10-26WarningsExact identifier
unii: WK2XYI10QM
Grain and Seed AntigensBAMBOO, BARLEY, CORN, COTTON SEED, FLAX SEED (LINUM USITATISSIMUM), MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SAFFLOWER, SESAME, SORGHUM, SOY BEAN, SUGARCANE, SUNFLOWER (HELIANTHUS ANNUUS), WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUREnergique, Inc.a028eaea-76ef-45db-80e1-d7b4a0655d5e2024-10-25WarningsExact identifier
unii: C151H8M554
Ibuprofen Pain Reliever/Fever ReducerIBUPROFENAmneal Pharmaceuticals LLC877440fc-3afb-4123-a2e6-5cb48c74413c2024-10-25WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen Pain Reliever/Fever ReducerIBUPROFENAmneal Pharmaceuticals LLC5f27dd3f-c735-417b-95e6-26dc5aae5a7a2024-10-25WarningsExact identifier
unii: WK2XYI10QM
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.ae367381-7146-4307-823d-2bb44c1d42002024-10-25WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLCc01116d3-32f8-41f0-8e31-c4142265ef562024-10-24WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions2d0c2d35-c212-4daa-b2c4-b407ca0b16ad2024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions2b470e48-c23c-4f5c-916a-d38d8518896b2024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Bliss GVS ChildrenGLYCERINBliss GVS Pharma Limited03237ed2-265f-4acd-b504-d82b9263287c2024-10-17WarningsExact identifier
unii: PDC6A3C0OX
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMMeijer Distribution Incfb170371-2e5d-43ca-a259-538a973ee3b82024-10-15WarningsExact identifier
unii: PDC6A3C0OX
kirkland signature ibuprofen ibIBUPROFENCostco Wholesale Company2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c2024-10-14WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutionsb87cf806-1635-44d5-a9de-383081cb37d82024-10-14WarningsExact identifier
application number: ANDA209207
rxcui: 197803
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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