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 31 of 88 · 1,751 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENStrides Pharma Science Limiteda266a3c6-932f-476f-ae93-48a785c922862025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen 572IBUPROFENFamily Dollar Services, Inc.1a2182df-4339-442d-9c61-98c8b01e36fa2025-12-03WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENFamily Dollar Services, Inc.137a0290-822a-842d-e063-6294a90a5c182025-12-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRedpharm Drug44f278ac-6bf9-6aef-e063-6394a90a0bb62025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRedpharm Drug44f5743f-8c98-dc4d-e063-6294a90a6dfa2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRedpharm Drug44f609dd-c868-493f-e063-6294a90a71382025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENProficient Rx LPa7098fa1-b5ae-485e-ada9-64154f81fb6a2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Advil Dual Action with Acetaminophen, Travel BASIXIBUPROFEN, ACETAMINOPHEN TABLET, FILM COATEDLil' Drug Store Products, Inc.030d9bca-a934-6ef9-e063-6394a90a82772025-12-01WarningsExact identifier
unii: WK2XYI10QM
Lil Drug Store IbuprofenIBUPROFENLil Drug Store Products, Incc3be5923-9299-49b0-a455-e0c1c86985a82025-12-01WarningsExact identifier
unii: WK2XYI10QM
CAREALL IbuprofenIBUPROFENNew World Imports246cf64a-162d-47a4-910a-9fb0b9be3dd12025-12-01WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENQPharma, Inc.f452d2c3-525f-4933-b146-92351d0ae44f2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
BUDDATE INONOTUS OBLIQUUS WATER BRILLIANCE MASKBUTYLENE GLYCOL, GLYCERIN, INONOTUS OBLIQUUS (MUSHROOM) EXTRACTBUDDATE Co Ltd464988ad-557e-13f5-e054-00144ff8d46c2025-11-30WarningsExact identifier
unii: PDC6A3C0OX
BUDDATE LOTUS MOISTURE ESSENCEGLYCERIN, NIACINAMIDE, NELUMBO NUCIFERA FLOWER EXTRACT, PORTULACA OLERACEA EXTRACTBUDDATE Co Ltd46499995-8b13-3e5c-e054-00144ff88e882025-11-30WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENA-S Medication Solutions71b5b2a2-397e-4dcb-b0c7-ef08df4337e02025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions47711610-6577-4805-a2ce-cf9b7cbfa8122025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: XF417D3PSL
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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