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 38 of 87 · 1,740 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx3f16596d-dd5a-7985-e063-6294a90a6f9d2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral Suspension Dye FreeIBUPROFENFSA Store Inc. (Caring Mill)099e374b-49c2-4d56-a047-d4f0c4af34ba2025-09-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.06710aef-2631-4925-8e9e-33bae84b59122025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepack86fc38bc-7f54-4aab-9c4d-d0898a4381f92025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackd50f829d-071f-4299-9b74-0f28caac71182025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh RelievaCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.6b984fa2-4187-45ef-b7d3-15e720abc6672025-09-15WarningsExact identifier
unii: PDC6A3C0OX
ibuprofenIBUPROFENMeijer Distribution Ince28e64dc-5f4e-4260-953a-3de38a5eaa762025-09-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS Pharmacy. Inc.d4336a7c-fb9f-1fbe-e053-2995a90af3652025-09-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS Pharmacy.Inc.cd0c3404-9e9d-bfad-e053-2995a90a87192025-09-13WarningsExact identifier
unii: WK2XYI10QM
Oasis Tears PF Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.640f95f4-c2e8-48ad-ad40-f76bbaddb0dc2025-09-12WarningsExact identifier
unii: PDC6A3C0OX
ibuprofenIBUPROFENA-S Medication Solutions7d4ba8be-df59-4a21-8850-8a59bf72b6042025-09-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepack894a5d14-e405-43ac-a5a2-0b4de5b284742025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHEBacf86f62-1d55-4281-95b7-8b2b51eb7c892025-09-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHEBc04ad0b4-5d8a-4861-9eaa-b2aaa7b196642025-09-10WarningsExact identifier
unii: WK2XYI10QM
Green Guard Ibupro reliefIBUPROFENUnifirst First Aid Corporation2923c4a3-f994-67a7-e054-00144ff8d46c2025-09-09WarningsExact identifier
unii: WK2XYI10QM
Medique IprinIBUPROFENUnifirst First Aid Corporation2910b50b-c8de-382b-e054-00144ff88e882025-09-09WarningsExact identifier
unii: WK2XYI10QM
Green Guard Ibuprofen ReliefIBUPROFENUnifirst First Aid0798e401-8247-2fce-e054-00144ff8d46c2025-09-09WarningsExact identifier
unii: WK2XYI10QM
Medique at Home IprinIBUPROFENUnifirst First Aid Corporationb5547f33-2a81-867d-e053-2995a90aa2d02025-09-09WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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