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 30 of 95 · 1,896 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Ibuprofen Oral Suspension Original Berry FlavorIBUPROFENPuro Pharma Inc.6b993b25-9c81-4d75-b332-6de3f6c3b4c92025-12-27WarningsExact identifier
application number: ANDA210602
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENSun Pharmaceutical Industries, Inc.a8b46ae5-67bc-494d-850e-b4e4ed5a33b32025-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENNorthwind Health Company, LLCf2a08223-a73a-5461-e053-2995a90a3bce2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNorthwind Health Company, LLCab074ae8-5696-5327-e053-2a95a90a7ce32025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral SuspensionIBUPROFENAptaPharma Inc.40936019-74ab-4b25-a502-7bbc6e12034a2025-12-26WarningsExact identifier
application number: ANDA210602
rxcui: 197803
unii: WK2XYI10QM
Childrens Ibuprofen GrapeIBUPROFENAptaPharma Inc.7caca7e2-6652-45fc-9538-275b43a1594e2025-12-26WarningsExact identifier
application number: ANDA210602
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46a9424c-fd7d-f88b-e063-6294a90abceb2025-12-24WarningsExact identifier
unii: WK2XYI10QM
Lil Drug Store IbuprofenIBUPROFENLil Drug Store Products, Inc29190ebf-bb9c-4406-be7b-4427741aeb742025-12-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS10424ad8-74fc-4f5f-e063-6394a90a13bd2025-12-23WarningsExact identifier
unii: WK2XYI10QM
good sense ibuprofen childrensIBUPROFENPreferred Pharmaceuticals Inc.7ac61180-d668-4eec-b04f-d14f7b552a4d2025-12-23WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Hydrocodone Bitartrate and IbuprofenHYDROCODONE BITARTRATE AND IBUPROFENAurolife Pharma, LLC470df63a-5c0f-42df-9023-a330a901153e2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Motrin IB MigraineIBUPROFENKenvue Brands LLC34818110-5291-4bda-9571-bd77d90bba7c2025-12-22WarningsExact identifier
unii: WK2XYI10QM
Motrin IBIBUPROFENKenvue Brands LLCd9fc716a-fba5-45f8-8024-52325799d1dd2025-12-22WarningsExact identifier
unii: WK2XYI10QM
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINHanlim46851e7c-8910-6456-e063-6394a90abafb2025-12-22WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHanlim46854996-a0b9-46b4-e063-6294a90aa4332025-12-22WarningsExact identifier
unii: K679OBS311
IbuprofenIBUPROFENGranules USA, Inc.8cb595d2-b7c2-687d-e053-2a95a90a57202025-12-22WarningsExact identifier
unii: WK2XYI10QM
Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEKC Pharmaceuticals, Inc4682f68d-6bdd-d860-e063-6394a90a2b522025-12-21WarningsExact identifier
unii: PDC6A3C0OX
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart44494842-e38d-617c-e063-6294a90afaf82025-12-20WarningsExact identifier
unii: K679OBS311
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart443e214b-2680-79a9-e063-6294a90a68ba2025-12-20WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
Equate Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEWalmart44155cf8-6fd9-d16f-e063-6394a90ac7312025-12-20WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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