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 43 of 95 · 1,882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Uline IbuprofenIBUPROFENUlined7342a15-9d49-74ed-e053-2a95a90a22cc2025-09-09WarningsExact identifier
unii: WK2XYI10QM
McKesson Ibuprofen 200 mgIBUPROFENMcKesson Medical-Surgicalca75b9fe-5bc8-ab90-e053-2995a90a52fb2025-09-09WarningsExact identifier
unii: WK2XYI10QM
Oasis TEARS PF PLUS Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.5d080191-423d-4c0a-b5ae-2ccf5c4a67cb2025-09-08WarningsExact identifier
unii: PDC6A3C0OX
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Henry Schein IbuprofenIBUPROFENHenry Schein Inc.267c7c8a-2f3f-1f4d-e054-00144ff8d46c2025-09-08WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen ThompsonIBUPROFENThompson Safetyccfbc048-f666-3188-e053-2995a90ae08f2025-09-08WarningsExact identifier
unii: WK2XYI10QM
GlycerinGLYCERINRising Pharma Holdings, Inc.db539b39-9504-44d2-9bd5-ba6ffb4410242025-09-08WarningsExact identifier
unii: PDC6A3C0OX
Glycerin ChildrenGLYCERINRising Pharma Holdings, Inc.80a5a944-2882-4f8d-a955-ef827cead5f02025-09-08WarningsExact identifier
unii: PDC6A3C0OX
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
CombogesicACETAMINOPHEN AND IBUPROFENPreferred Pharmaceuticals Inc.cd03b658-dba1-4a12-8f6f-ab00da499c052025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENWalgreen Company37c9b887-190a-4daf-8199-f406913132f02025-09-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSam's West Inc6293a134-860d-4d12-9e4b-28490f8241082025-09-03WarningsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENBetter Living Brands, LLCfab39a0a-882b-bf96-e053-6294a90a29322025-09-02WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENWALGREEN CO.fea3c4b2-cf96-2425-e053-6394a90ac6972025-09-02WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFEN7-Elevenaf0ec23c-cefc-40a9-ab9a-03b8528d4e132025-09-01WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENAurohealth LLC0e1bcb06-be48-4efc-82e2-516582e023482025-09-01WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENKROGER COMPANY15e72384-3a04-242d-e063-6294a90aa0fa2025-09-01WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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