FDA.reportPublic FDA data

NDC 70677-0150-01 - 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
70677-0150
Requested NDC
70677-0150-01
Package NDCs from labels
70677-0150-1, 70677-0150-2, 70677-0150-01
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
70677-0150-1Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1181
70677-0150-1Ibuprofen Oral1 in 1 CARTONSUSPENSION11
70677-0150-2Ibuprofen Oral1 in 1 CARTONSUSPENSION11
70677-0150-2Ibuprofen Oral237 mL in 1 BOTTLESUSPENSION2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0150IBUPROFEN ORAL (IBUPROFEN ORAL) SUSPENSION [STRATEGIC SOURCING SERVICES]1Current NDC, Legacy NDC, 4 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
70677-0150-1ML - Milliliter70677-0150a2259fb3-e1c5-4f28-861f-988a940ca04812023-02-06
70677-0150-2ML - Milliliter70677-0150d79f7395-198d-4247-be5a-5cfc12257af512023-02-06

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 34 of 95 · 1,882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRINBayer HealthCare LLC.49b73bd5-6465-05eb-e054-00144ff88e882025-12-04WarningsExact identifier
unii: XF417D3PSL
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
unii: XF417D3PSL
IbuprofenIBUPROFENStrides Pharma Science Limiteda266a3c6-932f-476f-ae93-48a785c922862025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen 572IBUPROFENFamily Dollar Services, Inc.1a2182df-4339-442d-9c61-98c8b01e36fa2025-12-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENFamily Dollar Services, Inc.137a0290-822a-842d-e063-6294a90a5c182025-12-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENRedpharm Drug44f278ac-6bf9-6aef-e063-6394a90a0bb62025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRedpharm Drug44f5743f-8c98-dc4d-e063-6294a90a6dfa2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRedpharm Drug44f609dd-c868-493f-e063-6294a90a71382025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENProficient Rx LPa7098fa1-b5ae-485e-ada9-64154f81fb6a2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Advil Dual Action with Acetaminophen, Travel BASIXIBUPROFEN, ACETAMINOPHEN TABLET, FILM COATEDLil' Drug Store Products, Inc.030d9bca-a934-6ef9-e063-6394a90a82772025-12-01WarningsExact identifier
unii: WK2XYI10QM
Lil Drug Store IbuprofenIBUPROFENLil Drug Store Products, Incc3be5923-9299-49b0-a455-e0c1c86985a82025-12-01WarningsExact identifier
unii: WK2XYI10QM
CAREALL IbuprofenIBUPROFENNew World Imports246cf64a-162d-47a4-910a-9fb0b9be3dd12025-12-01WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENQPharma, Inc.f452d2c3-525f-4933-b146-92351d0ae44f2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
BUDDATE INONOTUS OBLIQUUS WATER BRILLIANCE MASKBUTYLENE GLYCOL, GLYCERIN, INONOTUS OBLIQUUS (MUSHROOM) EXTRACTBUDDATE Co Ltd464988ad-557e-13f5-e054-00144ff8d46c2025-11-30WarningsExact identifier
unii: PDC6A3C0OX
BUDDATE LOTUS MOISTURE ESSENCEGLYCERIN, NIACINAMIDE, NELUMBO NUCIFERA FLOWER EXTRACT, PORTULACA OLERACEA EXTRACTBUDDATE Co Ltd46499995-8b13-3e5c-e054-00144ff88e882025-11-30WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENA-S Medication Solutions71b5b2a2-397e-4dcb-b0c7-ef08df4337e02025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
unii: 6DC9Q167V3
IbuprofenIBUPROFENA-S Medication Solutions47711610-6577-4805-a2ce-cf9b7cbfa8122025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: XF417D3PSL
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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