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 41 of 95 · 1,882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENPHOENIX RX LLC40202c76-4275-88fd-e063-6394a90a07b22025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
careone ibuprofenIBUPROFENAmerican Sales Company2720b8aa-4361-4cd4-be26-aa6dd1692d122025-10-01WarningsExact identifier
unii: WK2XYI10QM
Xpect Industrial Eye ReliefGLYCERIN, NAPHAZOLINE HCLCintas Corporationa0167d06-7adb-36f4-e053-2a95a90af9ef2025-09-30WarningsExact identifier
unii: PDC6A3C0OX
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Childrens IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.a1a5a9c7-c727-4e41-a8f0-2982f796a3ca2025-09-29WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
leader ibuprofenIBUPROFENCardinal Health 110, LLC. dba Leader96da60f7-06a9-438a-ae59-8609fdd1587d2025-09-25WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENKroger Companybc173f1b-2e44-2c2e-e053-2a95a90a89c42025-09-24WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENKroger Companybbedfc37-913d-8046-e053-2995a90af68a2025-09-24WarningsExact identifier
unii: WK2XYI10QM
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
pain reliefIBUPROFENMeijer, Inc.ae39917e-1998-4298-8686-919c0d3c2b072025-09-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepack7acdd557-0b6c-48f5-9437-7bc567af1f852025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx3f16596d-dd5a-7985-e063-6294a90a6f9d2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral Suspension Dye FreeIBUPROFENFSA Store Inc. (Caring Mill)099e374b-49c2-4d56-a047-d4f0c4af34ba2025-09-18WarningsExact identifier
application number: ANDA210602
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.06710aef-2631-4925-8e9e-33bae84b59122025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepack86fc38bc-7f54-4aab-9c4d-d0898a4381f92025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackd50f829d-071f-4299-9b74-0f28caac71182025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311

Reported adverse events (FAERS/openFDA)#

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