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 13 of 95 · 1,896 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENFamily Dollar (FAMILY WELLNESS)da16b1a9-0db2-4f2f-bc85-05ea5ab26e1c2026-05-27WarningsExact identifier
unii: WK2XYI10QM
Motrin IBIBUPROFENSelect Consumer Group LLC52c650cf-3085-7b2c-e063-6394a90a797f2026-05-27WarningsExact identifier
unii: WK2XYI10QM
ADVIL PMDIPHENHYDRAMINE CITRATE AND IBUPROFENSelect Consumer Group52c67ae0-707c-851b-e063-6294a90afda42026-05-27WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.52d3e633-13a2-cdcd-e063-6394a90ac1892026-05-27WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
ibuprofenIBUPROFENRite Aid Corporation69ca781a-202e-4579-91e6-f32a22ccc22c2026-05-27WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENRite Aid Corporation5883ebd4-8cf7-45f1-8c66-e87416835fcc2026-05-27WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENRite Aid Corporation99a76de3-166a-4902-b400-b262a4fa0ae82026-05-27WarningsExact identifier
unii: WK2XYI10QM
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: PDC6A3C0OX
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
unii: PDC6A3C0OX
IBUPROFENIBUPROFENSt. Mary's Medical Park Pharmacy950c3ca7-4481-976f-e053-2995a90ad51e2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENAurohealth LLC7461e50d-bfa1-4627-b691-089636b979d22026-05-22WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENCVS Pharmacy121b13c8-0b1a-4c48-9d57-3b53a9228d342026-05-22WarningsExact identifier
unii: WK2XYI10QM
Berkley and Jensen IbuprofenIBUPROFENBJWCcda57e42-6106-46ee-82d1-479a692ee5bb2026-05-21WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGrocery Outlet, Inc.441d762d-9022-426a-e063-6294a90a50762026-05-21WarningsExact identifier
unii: WK2XYI10QM
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENSalado Sales, Inc.06bc4445-5c80-4dd3-b1bb-d9244f45f5702026-05-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCardinal Health 107, LLC260f5862-d65d-4c34-bf53-26ca30806a672026-05-19WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)7af82ca5-ea36-4b72-88b8-0fe68348d2692026-05-19WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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