FDA.reportPublic FDA data

NDC 59368-003 - up and up dye free infants concentrated 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
59368-003
Package NDCs from labels
59368-003-01, 59368-003-02
Manufacturer
Sixarp, LLC
Effective date
2024-03-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
up and up dye free infants concentrated ibuprofen - Sixarp, LLCSixarp, LLC2024-03-15HUMAN OTC DRUG LABEL

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 20 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.4b34b58b-2cf7-9aa8-e063-6294a90a06582026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
CVS IbuprofenIBUPROFENCVS Pharmacy3d71e29f-0648-7377-e063-6294a90a8a292026-02-17WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions0170876a-d8cd-4a2d-8397-db2acdf72ffb2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen ChildrensIBUPROFENMajor Pharmaceuticals9d56e64d-7860-4fd1-88d2-c537e50079d82026-02-13WarningsExact identifier
unii: WK2XYI10QM
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
childrens ibuprofenIBUPROFENHyVee Incd522a3ac-dd43-4faa-b3f8-69313be1c8292026-02-11WarningsExact identifier
unii: WK2XYI10QM
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
good sense dual actionACETAMINOPHEN, IBUPROFENSportpharm LLC3f4ade2c-56e0-4aab-910e-73c26546a4d72026-02-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMajor Pharmaceuticals42b6faf5-ef47-6a7a-e063-6394a90ac4092026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENHyVee Inc4c24c884-55f7-40b4-8d6f-db6144d5ebcb2026-02-05WarningsExact identifier
unii: WK2XYI10QM
CareOne IbuprofenIBUPROFENAmerican Sales Company03cdff8a-8890-440d-82b5-54ce809f88cc2026-02-03WarningsExact identifier
unii: WK2XYI10QM
Pain Relief IbuprofenIBUPROFENRite Aid Corporationc85c3d1f-7639-4cfa-bf3a-424b61757b1a2026-02-03WarningsExact identifier
unii: WK2XYI10QM
Motrin Dual Action With TylenolACETAMINOPHEN AND IBUPROFENKenvue Brands LLCf2ee9cf5-02b7-6612-e053-2995a90a90c42026-02-03WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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