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 10 of 95 · 1,896 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENWhole Foods Market, INC.32348505-744c-fbfd-e063-6394a90a82d72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERISOURCE BERGEN1afcf0c6-bd41-4621-9e44-d97b81221c122026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERISOURCE BERGENa13cee82-1c4e-0cbe-e053-2a95a90a3ab82026-06-23WarningsExact identifier
unii: WK2XYI10QM
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENA-S Medication Solutions51de1183-d226-4869-a00a-f6c74e126a392026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions25a94943-9acc-49c8-a4da-7e07bb2c35eb2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTopco Associates, LLC59a88ca7-eb37-46de-9134-a5a6d330bd492026-06-23WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx54d9e1fc-507d-1859-e063-6394a90a8c6b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCardinal Health 107, LLC8ea0e303-3967-4d71-8255-ac42a841ce282026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC548c705e-4094-fc6f-e063-6394a90a34262026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.027ded51-aa01-6619-3938-c8162a421cf32026-06-18WarningsExact identifier
unii: WK2XYI10QM
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER06dd551b-6e13-425c-8d64-8d3177adc6bc2026-06-16WarningsExact identifier
unii: WK2XYI10QM
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
unii: PDC6A3C0OX
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
unii: PDC6A3C0OX
Childrens Ibuprofen Bubblegum Dye FreeIBUPROFENCVS2cf2f35b-5d66-e3ff-e063-6294a90a9b452026-06-16WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
IBUPROFENIBUPROFENGranules India Limited97516b9f-219a-429d-850d-1fe9fd66646b2026-06-15WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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