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 24 of 95 · 1,882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENL.N.K. International, Inc.82e907e6-86a9-5c7f-93bd-a6319d74100f2026-01-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHYVEE INC45aead8a-37ee-9a66-e063-6394a90a5d172026-01-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHYVEE INC459fc063-0664-09b7-e063-6394a90a89e02026-01-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHYVEE INC459fc670-32a3-61a6-e063-6294a90aea5a2026-01-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.8ebe3e16-b7ae-d333-6671-5bc935e259002026-01-13WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENHyVee Inc2fd51545-1d1f-4b2e-a084-d28ba223e7202026-01-13WarningsExact identifier
unii: WK2XYI10QM
ibuprofen infantsIBUPROFENHyVee Ince8fcaf17-234a-4d64-b621-9ca505884b0a2026-01-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c2026-01-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMeijer Distribution Incc0c64ba5-b6b0-4221-9e44-110d92c937822026-01-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCoupler LLC4831785a-cde2-79a2-e063-6294a90a9a402026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENBIONPHARMA INC.4834aa7f-cb0c-ec58-e063-6394a90ae2fc2026-01-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.c93da67f-f42e-4baa-976b-73c71ba6dd712026-01-12WarningsExact identifier
unii: WK2XYI10QM
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
unii: PDC6A3C0OX
GOOD SENSE CHILDRENS IBUPROFENIBUPROFENL. Perrigo Companycd06ffc5-4921-4b2d-88ea-939fa4daf59c2026-01-09WarningsExact identifier
unii: WK2XYI10QM
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
unii: TTV12P4NEE
Brain Enhancement Liquescence 3006BRAIN ENHANCEMENT LIQUESCENCEProfessional Complementary Health Formulas33bb2104-c16a-49e4-b292-69e10c1f16c02026-01-08WarningsExact identifier
unii: PDC6A3C0OX
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb4697319-438e-2ec8-e053-2a95a90abb562026-01-08WarningsExact identifier
unii: K679OBS311
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb478a695-ded0-2e5f-e053-2995a90ac45e2026-01-08WarningsExact identifier
unii: K679OBS311
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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