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 81 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENTOPCO ASSOCIATES LLCcef74c2f-0c23-609d-e053-2a95a90a6b8e2022-11-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCare One (American Sales Company)016299ef-ad40-46fd-acfc-e74ffee3d9b42022-11-21WarningsExact identifier
unii: WK2XYI10QM
signature care childrens ibuprofenIBUPROFENSafewayc30fbb8f-a293-4f6e-9495-11402548fe2d2022-11-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)7f510feb-023c-4974-af6d-3e7a30cef3622022-11-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8de40427-1be3-4a86-bc4c-9659ebaa203f2022-11-07WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLAmerisource Bergen8d397f4f-ac5e-426d-a26b-ee064b6e50282022-11-04WarningsExact identifier
unii: WK2XYI10QM
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: XF417D3PSL
IbuprofenIBUPROFENProficient Rx LP9e9fb921-6b6a-422e-95b6-41d6b9047b802022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: XF417D3PSL
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: XF417D3PSL
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
DG Health childrens ibuprofenIBUPROFENDolgencorp, LLC0fd6fcca-cbfe-48af-80dd-2607b5d51b532022-10-13WarningsExact identifier
unii: WK2XYI10QM
Circle K IbuprofenIBUPROFENLil Drug Store Products, Inc791a7375-34b2-449b-9284-3c49a27046192022-10-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPharmPak, Inc.b493bf76-1e8b-4e72-bef6-aca4efc69cbe2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPharmPak, Inc.4d95bccd-8280-4d03-a574-927669c7cda02022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPharmPak, Inc.bb6d0547-c113-42f9-8bf2-c227a55ab7582022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: PDC6A3C0OX
Circle K IbuprofenIBUPROFENLil Drug Store Products, Inc805d9d80-7de7-49d9-afdb-3a645059fe352022-09-21WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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