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 12 of 95 · 1,896 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENAscend Laboratories, LLC9ce036ef-a22d-4fca-9a62-1b10978f7b262026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLC43c94480-78d1-4a23-91d4-1d49fea72cb72026-06-05WarningsExact identifier
unii: WK2XYI10QM
REFRESH CELLUVISCCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.b32ed9e8-d091-4f16-b416-5a62cdfee49a2026-06-05WarningsExact identifier
unii: K679OBS311
Ibuprofen MinisIBUPROFENVivunt Pharma LLCc46803db-feb7-435c-ac42-cffa99d35f462026-06-04WarningsExact identifier
unii: WK2XYI10QM
dual actionACETAMINOPHEN, IBUPROFENPublix Super Markets Ince185d119-3484-40b1-afb8-6dca49d45e402026-06-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMedline industries, LP5d2482b4-cd90-4246-85a9-fd1d35315b6c2026-06-04WarningsExact identifier
unii: WK2XYI10QM
dual pain relieverACETAMINOPHEN, IBUPROFENMeijer, Inc.db1dc4f6-23ec-4a04-baa8-ffa739bce76a2026-06-04WarningsExact identifier
unii: WK2XYI10QM
DUAL ACTIONACETAMINOPHEN, IBUPROFENAmazon.com Services LLC20fe6b3f-e5a6-47d4-a371-9172408fbc462026-06-04WarningsExact identifier
unii: WK2XYI10QM
acetaminophen and ibuprofenACETAMINOPHEN, IBUPROFENKroger Companye6c0cca6-812e-4bea-86b0-e15b10f3f0d42026-06-04WarningsExact identifier
unii: WK2XYI10QM
topcare dual actionACETAMINOPHEN, IBUPROFENTopco Associates LLCdddc04c4-d500-4d42-8406-89f27a9ad6512026-06-04WarningsExact identifier
unii: WK2XYI10QM
Basic Care IbuprofenIBUPROFENAmazon.com Services LLC4c1a1543-a2a2-43fb-901c-cf6bcc374a3f2026-06-03WarningsExact identifier
unii: WK2XYI10QM
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: PDC6A3C0OX
Period Pills by BiikayACETAMINOPHEN, IBUPROFENKai Squared40d2ae73-82cf-3fa1-e063-6394a90a9ea22026-06-01WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENCVS Pharmacy6d047655-2b29-4f74-ac6e-93b02c25870c2026-06-01WarningsExact identifier
unii: WK2XYI10QM
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
IbuprofenIBUPROFENRedpharm Drug5302291e-4816-8495-e063-6394a90a9cc02026-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENWal-Mart Stores Inccb897d65-7e98-4d02-be64-0704416a0f292026-05-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENFamily Dollar (FAMILY WELLNESS)5beb7c11-4ed4-4cd4-9c30-3b0c4016316f2026-05-27WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENRite Aid Corporation1da544eb-ed4e-4124-bea3-f827f13222702026-05-27WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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