FDA.reportPublic FDA data

NDC 66689-009-01 - Ibuprofen

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
66689-009
Requested NDC
66689-009-01
Package NDCs from labels
66689-009-01, 66689-009-50
Manufacturer
VistaPharm, Inc.
Effective date
2019-11-01
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 mLVistaPharm, Inc.2019-11-01HUMAN PRESCRIPTION DRUG LABEL
Ibuprofen - Cardinal HealthCardinal Health2018-10-26HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-009-01ML - Milliliter66689-0090607df43-62ad-450e-a5f3-6e1bae247e3b12013-02-13
66689-009-50ML - Milliliter66689-00975797402-6277-490c-b6e6-fcd37a22473712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
IbuprofenACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLIBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GIBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
HypromellosesINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
SucroseINACTIVE INGREDIENTC151H8M554IBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RIBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN SUSPENSION [VISTAPHARM, INC.]2
IbuprofenACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION [CARDINAL HEALTH]1
IbuprofenACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION [CARDINAL HEALTH]1
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLIBUPROFEN SUSPENSION [CARDINAL HEALTH]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GIBUPROFEN SUSPENSION [CARDINAL HEALTH]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN SUSPENSION [CARDINAL HEALTH]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN SUSPENSION [CARDINAL HEALTH]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN SUSPENSION [CARDINAL HEALTH]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN SUSPENSION [CARDINAL HEALTH]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN SUSPENSION [CARDINAL HEALTH]1
SucroseINACTIVE INGREDIENTC151H8M554IBUPROFEN SUSPENSION [CARDINAL HEALTH]1
WaterINACTIVE INGREDIENT059QF0KO0RIBUPROFEN SUSPENSION [CARDINAL HEALTH]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN SUSPENSION [CARDINAL HEALTH]1

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 17 of 88 · 1,751 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENBryant Ranch Prepack1ebf94fb-76b6-4c01-be1b-5750628275452026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFEN ORALAurobindo Pharma Limited758eeb45-e599-4c1a-969d-8fa33f27bf142026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENRite Aid Corporationd9eefb84-cc2e-4deb-a1c0-a7c21929f5ac2026-03-27WarningsExact identifier
unii: WK2XYI10QM
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen OralIBUPROFEN ORALCamber Consumer Care Incb2dd4863-613e-4a41-98c1-3191e41b84632026-03-26WarningsExact identifier
unii: WK2XYI10QM
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
Ibuprofen Dye FreeIBUPROFENWALMART INC.2b04d255-a1df-4698-9b5a-ad7a12205e1b2026-03-25WarningsExact identifier
unii: WK2XYI10QM
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.32edaf34-046e-4ded-8bee-493a0019d6bd2026-03-25WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.dda7645f-1666-4c1f-b974-01add2ea79ac2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
ADVIL ALLERGY SINUSCHLORPHENIRAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HCLHaleon US Holdings LLCecd6ea11-8b34-01b4-cbd9-901ba7a8f6e22026-03-23WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN AND DIPHENHYDRAMINE HCLWhole Foods Market, INC.4db58605-9cc7-e57e-e063-6294a90ab8002026-03-23WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN InfantsIBUPROFENSun Pharmaceutical Industries, Inc.bc816597-a85a-4143-9f99-bb0699ca57c52026-03-23WarningsExact identifier
unii: WK2XYI10QM
Dolex FlexIBUPROFENPharmadel LLC0543420d-a250-065d-e063-6294a90a005e2026-03-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWestminster Pharmaceuticals, LLC6f7e255f-48c9-4366-8725-7f8cbe1bb75a2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.2e0f74a5-b8f3-fc81-e063-6394a90a647a2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
DUAL ACTION BACK PAIN RELIEVERACETAMINOPHEN, IBUPROFENMeijer, Inc.8d9a0c56-ef22-45a6-8b1d-d2b2f32472102026-03-19WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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