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 45 of 95 · 1,882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equaline childrens ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI3a166a74-cdc4-4620-b796-750464e15dc02025-08-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBJWC (Berkley & Jensen / BJ's)2f322afb-bfc8-9dab-e063-6394a90a08b52025-08-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRite Aid Corporation9372c47d-2a3c-4f44-86f8-7568657844e72025-08-19WarningsExact identifier
unii: WK2XYI10QM
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
unii: PDC6A3C0OX
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader63b8d389-7feb-41d2-8970-b7d5660ccb4a2025-08-14WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENFSA STORE INC.ec6b1b86-46fc-7e82-e053-2a95a90ac1472025-08-12WarningsExact identifier
unii: WK2XYI10QM
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
unii: PDC6A3C0OX
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Childrens IbuprofenIBUPROFENPrecision Dose Inc.fbbc67a7-359f-4155-9367-3815c05ccf032025-08-08WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENPrecision Dose Inc.59b881f9-1830-4bce-99d2-9770c9b2575f2025-08-08WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENPROSTAT FIRST AID3bca27b4-3df6-b7d1-e063-6394a90ac6af2025-08-07WarningsExact identifier
unii: WK2XYI10QM
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCaf9ac948-440c-5abf-e053-2995a90af2b52025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
IbuprofenIBUPROFENEQUATE (WAL-MART STORES, INC.)104b5ac1-9c5e-40f8-a9b1-1761b495bb1c2025-08-06WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC3b9fdc48-c071-4e2c-e063-6294a90a679f2025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENMeijer, Inc.eed4f13d-4bee-4ccc-a651-a6f86d6d1f7b2025-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAsclemed USA, Inc.d7ed42c4-371c-4a54-ab15-0630656f04272025-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPHOENIX RX LLC3b17587e-b609-42a9-e063-6294a90ab1f82025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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