FDA.reportPublic FDA data

NDC 51672-1385-08 - 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
51672-1385
Requested NDC
51672-1385-08
Package NDCs from labels
51672-1385-8, 51672-1385-9, 51672-1385-08
Manufacturer
REMEDYREPACK INC.
Effective date
2026-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen Oral Suspension USP, 100 mg/5 mLREMEDYREPACK INC.2026-03-24HUMAN PRESCRIPTION DRUG LABEL
Ibuprofen Oral Suspension USP, 100 mg/5 mLSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-12-27HUMAN PRESCRIPTION DRUG LABEL
Ibuprofen Oral Suspension USP, 100 mg/5 mLPharmaceutical Associates, Inc.2024-11-21HUMAN PRESCRIPTION DRUG LABEL
Ibuprofen Oral Suspension USP, 100 mg/5 mLPreferred Pharmaceuticals Inc.2020-06-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1385-8Ibuprofen1 in 1 CARTONSUSPENSION18
51672-1385-8Ibuprofen118 mL in 1 BOTTLESUSPENSION1188
51672-1385-9Ibuprofen473 mL in 1 BOTTLESUSPENSION4738

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1385IBUPROFEN SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 3 package rows20250406_a8b46ae5-67bc-494d-850e-b4e4ed5a33b3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1385-8ML - Milliliter51672-138513a2a3e8-f834-4d2d-a6b8-b343115b264c12017-10-13
51672-1385-9ML - Milliliter51672-13857c8f4189-f5ee-4e29-8c05-9539e9dfe33f12017-10-13

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 8 of 88 · 1,751 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENUnit Dose Solutions, Inc.5515661b-6373-2191-e063-6294a90a17e02026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENUnit Dose Solutions, Inc.5515e80f-7513-b425-e063-6294a90aa5422026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen Mini Dye FreeIBUPROFENCVS Pharmacy42c7dbec-2e53-70ae-e063-6294a90a16e62026-06-25WarningsExact identifier
unii: WK2XYI10QM
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: PDC6A3C0OX
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENA-S Medication Solutionsb40f39e4-a37c-4039-ae37-210c1c3c62352026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)c62cc12f-5a0e-389a-e053-2995a90a208c2026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)c6297c23-3b27-c0c6-e053-2995a90a3e762026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.a139e495-3dbf-4998-e053-2a95a90ac1362026-06-23WarningsExact identifier
unii: WK2XYI10QM
pain reliefIBUPROFENBionpharma Inc.a14ca126-fada-c903-e053-2995a90ae72d2026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHEBca4be24c-5d92-ddc9-e053-2a95a90aa5a72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDOLGENCORP INC03138a6f-653a-f359-e063-6394a90ac5d62026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFEN CAPSULEPUBLIX SUPER MARKETS INC10a6eba7-e400-ce97-e063-6294a90af3bd2026-06-23WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENDISCOUNT DRUG MART, INC.d07ea9e3-88b0-4aa0-903a-10555dcca37d2026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDISCOUNT DRUG MART, INC.aae40114-343e-12da-e053-2a95a90a92132026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBJWC0ca0b6cf-7d1f-4673-b9b9-48f78d80c00a2026-06-23WarningsExact identifier
unii: WK2XYI10QM
pain reliefIBUPROFENBionpharma Inc.2b4ecdd8-627a-445f-8ddc-f2b6c832c1e82026-06-23WarningsExact identifier
unii: WK2XYI10QM
dye-free pain reliefIBUPROFENBionpharma Inc.c46c9c36-8844-7b50-e053-2a95a90aa0e92026-06-23WarningsExact identifier
unii: WK2XYI10QM
dye-free pain reliefIBUPROFENBionpharma Inc.4227d0b7-846a-dcb0-e063-6294a90af7d72026-06-23WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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