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 29 of 88 · 1,751 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENNuCare Pharmaceuticals, Inc.463ea713-6b27-b00b-e063-6394a90a86462025-12-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.a3c1a61b-88fc-419c-e053-2a95a90ac0c32025-12-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.8c3ca03e-0ec2-c15c-e053-2995a90ad8bd2025-12-18WarningsExact identifier
unii: WK2XYI10QM
LemonGLYCERINTwinMed LLCfc88eec0-c66c-5d6d-e053-6294a90a13d22025-12-18WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENA-S Medication Solutionse5db46f3-043b-40ac-a89b-c90bd562e7b42025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
HZ-ChordBAPTISIA TINCTORIA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MEZEREUM, MORBILLINUM, NUX VOMICA, PALOONDO, PHYTOLACCA DECANDRA, SEPIA, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Energetix Corporation9685aec5-a65d-40fe-b5d7-2f13a69733bc2025-12-17WarningsExact identifier
unii: XF417D3PSL
Category VIMMUNE SYSTEM BOOSTERVitality Works, Inc,0d3dd923-336c-4ccd-a344-ec49b2e80d102025-12-17WarningsExact identifier
unii: XF417D3PSL
IbuprofenIBUPROFENA-S Medication Solutions3db0c659-cc43-45dc-8442-bc89093d94d72025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLTARGET Corporation97e2c008-1711-dcba-e053-2995a90aa2ff2025-12-16WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLKROGER COMPANYca5418f2-4dc0-ad31-e053-2995a90ac1d32025-12-16WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENWALGREEN COMPANY2789fdef-2d8e-6247-e063-6394a90a974b2025-12-16WarningsExact identifier
unii: WK2XYI10QM
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
equate dual pain relieverACETAMINOPHEN, IBUPROFENWALMART INC.09dc976b-6065-4aad-9d57-0fe5e88a722a2025-12-15WarningsExact identifier
unii: WK2XYI10QM
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
unii: PDC6A3C0OX
topcare childrens ibuprofenIBUPROFENTopco Associates LLCd1bb68a6-3a29-4a4e-b4e9-413cc8d161912025-12-12WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETSMARKSANS PHARMA LIMITED46121a30-1361-4f2b-9f3f-3cedabd66c332025-12-12WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENDISCOUNT DRUG MART, INC.f9dfeb0e-0d4d-7348-e053-6394a90a8aef2025-12-12WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENBionpharma Inc.04ccc4b2-0cfd-3012-e063-6394a90afa792025-12-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY7e2ab4f1-2e87-4fbf-8882-e4d20aef142c2025-12-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANYa42f96c4-322d-4714-9435-7b5a4e8b6ae52025-12-11WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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