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 84 of 93 · 1,858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 6DC9Q167V3
CitriPlusJUGLANS REGIA WHOLE AND ANHYDROUS CITRIC ACIDPEKANA Natuheilmittel GmbH11db1b5b-2959-42c4-a059-25c9519330042023-01-11WarningsExact identifier
unii: XF417D3PSL
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Chip CravingsCOUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUSDr. Donna Restivo DC719ef104-88f3-4db5-9c3a-1ac9a1a63c262023-01-10WarningsExact identifier
unii: C151H8M554
Topcare IbuprofenIBUPROFENTopco Associates LLC742f33fa-8923-4415-bcd6-8db37f2e19742023-01-06WarningsExact identifier
unii: WK2XYI10QM
Flex-PrinIBUPROFENProvision Medical Productsc01538b0-ca4c-434a-be8f-fe023deb84e12023-01-05WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENDOLGENCORP INC8f1358aa-495a-23da-e053-2995a90aa4302023-01-02WarningsExact identifier
unii: WK2XYI10QM
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), PHLORIDZINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, BARYTA OXALICA, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS,Deseret Biologicals, Inc.5117f980-95b8-4fc8-9425-8f6f056394372022-12-29WarningsExact identifier
unii: XF417D3PSL
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)c62c6319-65eb-37e8-e053-2a95a90a9f902022-12-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWALGREEN COMPANY4ce20d2b-2dfb-4405-b545-dd1f67b2c5882022-12-28WarningsExact identifier
unii: WK2XYI10QM
Migraine ReliefIBUPROFENWALGREENS3d560acb-3334-4a39-9ab1-f131060e3b332022-12-28WarningsExact identifier
unii: WK2XYI10QM
Dye-Free Ibuprofen 200IBUPROFENWALGREEN COMPANYb9ff2469-22c7-fc70-e053-2a95a90abc492022-12-28WarningsExact identifier
unii: WK2XYI10QM
Dye-Free Ibuprofen 200IBUPROFENWALGREEN COMPANYbcd15c0f-8231-296f-e053-2995a90a280c2022-12-28WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWal-Mart Stores, Inc.ba31970a-b952-467c-b3f8-44f7a513de342022-12-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWal-Mart Stores, Inc.9e5332ab-92bc-3a33-e053-2995a90a642d2022-12-28WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.c483bbd6-934b-660a-e053-2995a90a51b32022-12-27WarningsExact identifier
unii: WK2XYI10QM
Dye-Free IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.d0eff659-6445-a56a-e053-2995a90a72e92022-12-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.553d16e1-928e-4919-bc53-6683a035e2b02022-12-27WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS Pharmacyce4378c0-848e-7878-e053-2a95a90af0f32022-12-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENKROGER COMPANY3b95dcbf-aef1-44b5-a2c4-5ce93c57ff1d2022-12-27WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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