FDA.reportPublic FDA data

NDC 70677-0152-01 - 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
70677-0152
Requested NDC
70677-0152-01
Package NDCs from labels
70677-0152-1, 70677-0152-01
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
70677-0152-1Ibuprofen Oral1 in 1 CARTONSUSPENSION11
70677-0152-1Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0152IBUPROFEN 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
70677-0152-1ML - Milliliter70677-0152bb59880f-140d-48e5-abd1-1bd53821bd8712023-02-06

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 18 of 95 · 1,896 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen OralIBUPROFEN ORALCamber Consumer Care Incb2dd4863-613e-4a41-98c1-3191e41b84632026-03-26WarningsExact identifier
application number: ANDA210602
rxcui: 197803
unii: WK2XYI10QM
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen Dye FreeIBUPROFENWALMART INC.2b04d255-a1df-4698-9b5a-ad7a12205e1b2026-03-25WarningsExact identifier
unii: WK2XYI10QM
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.32edaf34-046e-4ded-8bee-493a0019d6bd2026-03-25WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.dda7645f-1666-4c1f-b974-01add2ea79ac2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
ADVIL ALLERGY SINUSCHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCLHaleon US Holdings LLCecd6ea11-8b34-01b4-cbd9-901ba7a8f6e22026-03-23WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN AND DIPHENHYDRAMINE HCLWhole Foods Market, INC.4db58605-9cc7-e57e-e063-6294a90ab8002026-03-23WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN InfantsIBUPROFENSun Pharmaceutical Industries, Inc.bc816597-a85a-4143-9f99-bb0699ca57c52026-03-23WarningsExact identifier
unii: WK2XYI10QM
Dolex FlexIBUPROFENPharmadel LLC0543420d-a250-065d-e063-6294a90a005e2026-03-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWestminster Pharmaceuticals, LLC6f7e255f-48c9-4366-8725-7f8cbe1bb75a2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.2e0f74a5-b8f3-fc81-e063-6394a90a647a2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
DUAL ACTION BACK PAIN RELIEVERACETAMINOPHEN, IBUPROFENMeijer, Inc.8d9a0c56-ef22-45a6-8b1d-d2b2f32472102026-03-19WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENNorthStar Rx LLCaeee629b-255c-40d8-8e95-779aec00f7232026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
AMAZON BASIC CARE IBUPROFEN PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEAmazon.com Services LLC10ec6386-db13-a9dd-e063-6294a90a82612026-03-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGrocery Outlet, Inc.44660e1d-79c2-34ce-e063-6294a90ade3f2026-03-17WarningsExact identifier
unii: WK2XYI10QM
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
CounterAct IBIBUPROFENMelaleuca, Inc7fafc13e-3fee-ace3-e053-2a91aa0ac2ea2026-03-17Boxed warning, WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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