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 55 of 95 · 1,882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare IbuprofenIBUPROFENTopco Associates LLC66097f19-227c-4f9c-a7f3-ab8476e1bb6e2025-04-08WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENMajor Pharmaceuticals14f43c32-0895-4ef2-aa54-52b952d058fd2025-04-08WarningsExact identifier
unii: WK2XYI10QM
parents choice infants ibuprofenIBUPROFENWal-Mart Stores Inca826d6cc-f582-4508-897d-0d637de0666c2025-04-07WarningsExact identifier
unii: WK2XYI10QM
leader infants ibuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderb72fdf65-8112-4d8b-b86f-8e17a40ee8e62025-04-07WarningsExact identifier
unii: WK2XYI10QM
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIea2ba726-0199-42ae-9c60-4b068df35e642025-04-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31f59d10-d821-2291-e063-6294a90ac5182025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31f61d5c-a3a3-3d47-e063-6394a90afb622025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN AND IBUPROFENDr. Reddy's Labortories Inc3e65c8a3-498e-1a2a-bb76-18e28ae2c73c2025-04-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31e6005b-492e-7936-e063-6394a90ad8012025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31e6ac7a-fa3e-4dd4-e063-6294a90a29af2025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENBryant Ranch Prepackb303b554-c457-4f2b-9931-48f30943178b2025-04-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENBryant Ranch Prepack87c9f15f-1196-477c-b5d2-3b875bea61d02025-04-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
dg health ibuprofenIBUPROFENDolgencorp Inc74f46147-b4c2-4bb3-bd0a-220c0a5403a62025-04-01WarningsExact identifier
unii: WK2XYI10QM
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEAilex Pharmaceuticals, LLC329655ae-c3c0-46b2-a925-e49777f2076b2025-03-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
good sense ibuprofenIBUPROFENL. Perrigo Company0cb4b0ef-5cdd-4c79-8718-4fb157a2c9482025-03-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC3140a614-c7ae-3062-e063-6394a90ad3d72025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
good sense ibuprofenIBUPROFENL. Perrigo Company3b78c004-e4fe-449c-86e9-52e8ccf127852025-03-25WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENWR Group, Inc.1e2feaf0-7fff-43d5-bcfe-9f2851bdc8052025-03-25WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen minisIBUPROFENWR Group, Inc.e9dad35a-6789-42d6-97da-521db7b164962025-03-24WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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