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 66 of 94 · 1,870 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENA-S Medication Solutionsb365be3a-91ad-46bf-a949-103c81f2359a2024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWestminster Pharmaceuticals, LLCeeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d2024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions0ce79e85-0b8b-436e-b895-ea5c02eaf4ba2024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions8d41cc03-dec6-4949-b7c1-7deb2897e2c42024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation86b3a329-c83f-4977-92f5-0e9dfe1872d72024-10-10WarningsExact identifier
unii: XF417D3PSL
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.23fb1113-9f1c-88e0-e063-6394a90a44502024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEBryant Ranch Prepackee69d3cb-dc95-410c-a7c8-6623073a923d2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENP & L Development, LLC1f9c94a6-938a-420f-b90c-36b3791e97ad2024-10-07WarningsExact identifier
unii: WK2XYI10QM
Bio Co-Enzyme PhaseCARDUUS MARIANUS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.afad858e-064f-454d-be78-da1501ffe8532024-10-04WarningsExact identifier
unii: XF417D3PSL
dual action pain relieverACETAMINOPHEN AND IBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.2397603c-8d87-2e65-e063-6394a90ab73e2024-10-03WarningsExact identifier
unii: WK2XYI10QM
dual action pain relieverACETAMINOPHEN AND IBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.23994b21-cbc2-5a34-e063-6394a90acfdf2024-10-03WarningsExact identifier
unii: WK2XYI10QM
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation39f2e11c-5a31-469f-b725-d096c16744212024-10-03WarningsExact identifier
unii: XF417D3PSL
IbuprofenIBUPROFENProficient Rx LP43ac478c-43db-4136-8fee-4a43b09681e52024-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENH E B2f193146-74b2-4941-893d-3d2f5c8ee6592024-10-01WarningsExact identifier
unii: WK2XYI10QM
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEZydus Pharmaceuticals USA Inc.204e84a7-5440-4537-9e40-06eb56c415e92024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Sodium Phenylacetate and sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATENavinta LLCfbc7bfe3-6faa-45a3-befb-9ad7963c05712024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Ibuprofen 200mgIBUPROFEN 200MGAllegiant Health265e2b47-d14a-45a8-adc0-7214e20571032024-09-30WarningsExact identifier
unii: WK2XYI10QM
Household DetoxPTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLONDeseret Biologicals, Inc.7e32c1f4-c88e-43d0-9f6c-de736d358d462024-09-27WarningsExact identifier
unii: K679OBS311
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
unii: C151H8M554
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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