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 49 of 95 · 1,882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENChain Drug Consortium, LLCf0f01b97-e52c-4077-a4c6-c59736f4c1712025-06-30WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC388e68dc-1822-f375-e063-6294a90a3d412025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
JUNIOR STRENGTH ADVILIBUPROFENHaleon US Holdings LLC07d4c400-b182-92f7-7574-9e0e94c39cce2025-06-27WarningsExact identifier
unii: WK2XYI10QM
leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader009dde4c-d944-4206-8c9f-35bc8fd927152025-06-26WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Ibuprofen ChildrensIBUPROFENKroger Company47a3b118-614d-405d-b80e-31f0b354c4302025-06-25WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Good Neighbor Pharmacy Childrens IbuprofenIBUPROFENAmerisource Bergen40a6a842-a85b-4e24-8786-32ecd74f68702025-06-25WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENSafeway1b7854d6-32b9-4410-bb40-0f02e46c79662025-06-24WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENKroger Company347dd263-ba0d-4a5a-8ac8-e586fcfd014e2025-06-23WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENWalgreen Company9c5c1f48-d285-4faa-96d0-b04f435c9c5c2025-06-23WarningsExact identifier
unii: WK2XYI10QM
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
unii: PDC6A3C0OX
Motrin IBIBUPROFENMorning Star OTCe69f00c4-b8ec-4a83-9eea-8cb2835ad7762025-06-19WarningsExact identifier
unii: WK2XYI10QM
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
IBUPROFENIBUPROFENAAA Pharmaceutical, Inc.1e686091-6456-36c8-e063-6294a90a38662025-06-17WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAAA Pharmaceutical, Inc.78cf5df8-392b-4a4e-b424-af765a6defdf2025-06-17WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENFSA STORE INC.ec6b015d-e72e-89c4-e053-2a95a90af81c2025-06-17WarningsExact identifier
unii: WK2XYI10QM
Topcare IbuprofenIBUPROFENTopco Associates LLC8be375b0-c729-49de-abc5-2e7d37144b892025-06-16WarningsExact identifier
unii: WK2XYI10QM
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen08d9477e-3033-4b74-8f81-934f39e37e552025-06-16WarningsExact identifier
unii: WK2XYI10QM
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI9bf3546a-9f94-47b5-9b01-aed93e69d5aa2025-06-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENCVS Pharmacye655bd64-dd82-46d8-87cc-2674beaffe202025-06-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENMajor Pharmaceuticals03993008-7bd2-465f-b5a9-1cbc3c1fff022025-06-16WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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