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 44 of 95 · 1,882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS IBUPROFENIBUPROFEN7-Elevencf7b38fc-0590-126a-e053-2a95a90a3e782025-09-01WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENChalkboard Healthc63eb5c6-adac-4d23-9661-1081ba4591ba2025-09-01WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENRandob Labs., Ltd.50d6bf9d-ae37-4af3-bfeb-cc0abf8cb0942025-09-01WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENAurohealth LLCad55d9b1-17b3-4a17-a4a3-d95ba29439592025-09-01WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
careone childrens ibuprofenIBUPROFENAmerican Sales Companybf88f91c-70ed-42be-b79c-ec60d4f0acda2025-08-30WarningsExact identifier
unii: WK2XYI10QM
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader5975c324-2906-4e71-9b88-2e772d9fbfde2025-08-28WarningsExact identifier
unii: WK2XYI10QM
Good Neighbor Pharmacy Childrens IbuprofenIBUPROFENAmerisource Bergenf0a7070b-8acf-49f0-88c8-c841f73242d82025-08-28WarningsExact identifier
unii: WK2XYI10QM
foster and thrive ibuprofenIBUPROFENStrategic Sourcing Services LLCcfa8578c-2bcc-4aa7-bb8c-0d0e193020ed2025-08-28WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
good neighbor pharmacy childrens ibuprofenIBUPROFENAmerisource Bergen7a314b7f-91d6-4196-bd96-2470ff7b0b252025-08-28WarningsExact identifier
unii: WK2XYI10QM
CAREONE DUAL ACTIONACETAMINOPHEN, IBUPROFENRetail Business Services, LLC76302cb3-0371-49ce-85d8-5f3785c370b02025-08-25WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRite Aid Corporation389454b7-c17d-4413-b1ab-dee9a13f81cf2025-08-25WarningsExact identifier
unii: WK2XYI10QM
Foaming Facial CleanserGLYCERIN, NIACINAMIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd396c1db9-a5d3-cc82-e063-6294a90a90bb2025-08-23WarningsExact identifier
unii: PDC6A3C0OX
Refresh RELIEVA PFCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.d5d3df4a-a311-4f2d-9a24-edfec1a6c9f92025-08-22WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
Refresh OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
childrens ibuprofenIBUPROFENKroger Company1b78bdeb-efb2-4f5a-af3f-d67d820908472025-08-22WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENPublix Super Markets Incc5cd3843-8d72-4850-bebe-4ac54e4f43fa2025-08-21WarningsExact identifier
unii: WK2XYI10QM
equate ibuprofenIBUPROFENWal-Mart Stores Incabef43bc-ee9b-4a9c-9cf9-36c3232139092025-08-21WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENBryant Ranch Prepack230fd746-92e0-40b6-9a90-595812bd8a182025-08-20WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENMeijer Distribution Incd42f9f7c-fe4f-45eb-a455-bffb41295fdc2025-08-20WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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