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 5 of 95 · 1,896 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENHarris Teeter9d5c994a-8363-4ddb-956c-e12b79a32a582026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter87ffbf01-54de-45a8-b2a3-367d219278822026-07-29WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHarris Teeter14515409-736f-4119-b6a0-cb19ee2e948e2026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6332026-07-29WarningsExact identifier
unii: WK2XYI10QM
ADVIL PMDIPHENHYDRAMINE HCL, IBUPROFENHaleon US Holdings LLC405afdb4-c157-1d88-f232-848063ba47142026-07-29WarningsExact identifier
unii: WK2XYI10QM
ADVIL COLD AND SINUSIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLC0da9ed22-bfb4-d61b-110b-0c7760332a982026-07-29WarningsExact identifier
unii: WK2XYI10QM
ADVIL MIGRAINEIBUPROFENHaleon US Holdings LLCe4a6219d-4ad4-0119-4cf8-7fc39b4b59792026-07-29WarningsExact identifier
unii: WK2XYI10QM
AdvilIBUPROFENHaleon US Holdings LLC1f01c10a-9434-91a4-2ee4-352315a6b6102026-07-29WarningsExact identifier
unii: WK2XYI10QM
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAscend Laboratories, LLC4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENH E B21567c0f-abba-4a40-a0b9-5ce49b3d96482026-07-28WarningsExact identifier
unii: WK2XYI10QM
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.656658cc-8cf0-42b6-af4f-4e3ab76486252026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.a7756b22-73cf-4262-aa8e-0577ddecd03b2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corp1ca722bb-940e-4b3e-9561-d87e2feb1ff82026-07-24WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corpfc6c29b4-f1b3-4cfe-8c96-564d083be39c2026-07-24WarningsExact identifier
unii: WK2XYI10QM
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
childrens ibuprofenIBUPROFENRite Aid Corporation26bccfc1-bc8d-4241-a078-c760048951c92026-07-24WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IBUPROFENIBUPROFENHF Acquisition Co LLC, DBA HealthFirst574b6f15-70bc-fca7-e063-6294a90a04552026-07-23WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENSafeway, Inc.a530d43d-e9c4-4edb-af66-c92860e46f452026-07-23WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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