FDA.reportPublic FDA data

NDC 70677-0153-01 - Ibuprofen Oral

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
70677-0153
Requested NDC
70677-0153-01
Package NDCs from labels
70677-0153-1, 70677-0153-01
Manufacturer
Strategic Sourcing Services | AptaPharma Inc.
Effective date
2022-08-10
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 mL (OTC)Strategic Sourcing Services | AptaPharma Inc.2022-08-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-0153-1Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1181
70677-0153-1Ibuprofen Oral1 in 1 CARTONSUSPENSION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0153IBUPROFEN ORAL (IBUPROFEN ORAL) SUSPENSION [STRATEGIC SOURCING SERVICES]1Current NDC, Legacy NDC, 2 package rows20220811_a3062142-db0e-4758-a762-2b2bb05670b1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0153-1ML - Milliliter70677-0153b4e8be0e-e5f7-4a79-9455-79aaa2fb6e4f12023-02-06

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 33 of 95 · 1,896 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: PDC6A3C0OX
equate dual pain relieverACETAMINOPHEN, IBUPROFENWALMART INC.09dc976b-6065-4aad-9d57-0fe5e88a722a2025-12-15WarningsExact identifier
unii: WK2XYI10QM
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
unii: PDC6A3C0OX
topcare childrens ibuprofenIBUPROFENTopco Associates LLCd1bb68a6-3a29-4a4e-b4e9-413cc8d161912025-12-12WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETSMARKSANS PHARMA LIMITED46121a30-1361-4f2b-9f3f-3cedabd66c332025-12-12WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENDISCOUNT DRUG MART, INC.f9dfeb0e-0d4d-7348-e053-6394a90a8aef2025-12-12WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENBionpharma Inc.04ccc4b2-0cfd-3012-e063-6394a90afa792025-12-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY7e2ab4f1-2e87-4fbf-8882-e4d20aef142c2025-12-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANYa42f96c4-322d-4714-9435-7b5a4e8b6ae52025-12-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY02e4418a-93ed-2212-e063-6294a90a6c8a2025-12-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY88b3f388-46d3-4e42-98fb-0351c76a15fc2025-12-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY36b95840-f621-437a-bf49-406d320964da2025-12-11WarningsExact identifier
unii: WK2XYI10QM
Kroger HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLKroger Company45b2dd86-7fb0-07bf-e063-6394a90a18842025-12-11WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen 24/7 Life by 7-ElevenIBUPROFEN TABLET, FILM COATEDLil' Drug Store Products, Inc.45b3b825-dab7-3328-e063-6294a90a7d2a2025-12-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC9c1ded4e-1d3b-1ab6-e053-2995a90aa80d2025-12-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC9c1cc205-b9e3-03fc-e053-2995a90aaffb2025-12-10WarningsExact identifier
unii: WK2XYI10QM
Motrin IB, TRAVEL BASIXIBUPROFENLil' Drug Store Products, Inc.c2b99756-3e03-4d9f-9ce6-7db879afe3a12025-12-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChartwell RX, LLC39f2664f-6c0a-4726-85d7-4227530d4a492025-12-10Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
FCS HPEPINEPHRINE,GLUTAMICACID,MUCUNAPRURIENSSEED,NIACINAMIDE,SEROTONIN,UBIDECARENONE,CORTICOTROPIN,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATECRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inc.ba8fed68-f27f-4651-adec-0994a53758872025-12-10WarningsExact identifier
unii: XF417D3PSL
FCS CPCORTICOTROPIN,GLUTAMICACID,MUCUNAPURIENSSEED,SEROTONIN,EPINEPHRINE,NIACINAMIDE,UBIDECARENONE,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,UNSPECIFIED,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATE,CRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inccb69e9d6-62a6-4af0-8d2d-1e68b0830a202025-12-10WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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