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 19 of 88 · 1,751 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENBryant Ranch Prepack0550fa2f-f25e-4abb-b10e-a3d05bdb32172026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackc38a03fa-6b9a-4737-a848-063ca5c580b92026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUOROFENDirect_Rx90b8b80e-ab30-3590-e053-2a95a90a70ef2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENLegacy Pharmaceutical Packaging, LLC5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDirect_Rx1aa11b52-1aca-9219-e063-6294a90a470f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen MinisIBUPROFENGrocery Outlet, Inc.44665e3d-37a7-a1a7-e063-6294a90ab3762026-03-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LPab2f1a30-611b-41b6-9baf-6a82305da8452026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: PDC6A3C0OX
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 6OZP39ZG8H
IbuprofenIBUPROFENCVS Pharmacyef204cc0-4009-4dd0-83e2-2b5ad6f984092026-02-27WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENCVS Pharmacy215e2275-2968-419c-9a89-8dbb3b4f4d2e2026-02-27WarningsExact identifier
unii: WK2XYI10QM
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
ibuprofenIBUPROFENCVS Pharmacye28d0916-8165-431c-a19c-ef7d4bb6b8e62026-02-26WarningsExact identifier
unii: WK2XYI10QM
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: XF417D3PSL
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderd673266c-3d2b-479f-9b53-cdd1b86513932026-02-25WarningsExact identifier
unii: WK2XYI10QM
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL
equate ibuprofen childrensIBUPROFENWal-Mart Stores Inc7817923f-4c21-4943-a7e2-dad4e2915fc42026-02-23WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENHyVee Incc20a9bc5-e481-4fb2-ad10-d01e83e43ca02026-02-21WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC4522b794-5c93-44cd-e063-6394a90ab39a2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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