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 51 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy ibuprofen childrensIBUPROFENAmerisource Bergen43b8e61b-3ac4-4a41-b682-67d08b212cc62025-04-18WarningsExact identifier
unii: WK2XYI10QM
Good Sense IbuprofenIBUPROFENL. Perrigo Company1a6b42be-c0c2-48f8-9ba3-22d1f0c0b18d2025-04-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAllegiant Health2ea039d6-f522-4103-a1f9-5b80a3b12a272025-04-14WarningsExact identifier
unii: WK2XYI10QM
up and up ibuprofenIBUPROFENTarget Corporation2919fe8b-9c76-4ef6-851e-3247782cef442025-04-11WarningsExact identifier
unii: WK2XYI10QM
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIe18f4ce6-d7d3-4b53-b87a-5900ac3397f12025-04-11WarningsExact identifier
unii: WK2XYI10QM
IBUIBURedPharm Drug, Inc.4db219dc-ea48-490c-e054-00144ff88e882025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Advil Allergy and Congestion ReliefCHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa6cc97d8-252a-4527-a470-6d9e356342fd2025-04-09WarningsExact identifier
unii: WK2XYI10QM
Bio Co Enzyme PhaseACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM,Deseret Biologicals, Inc.6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db2025-04-08WarningsExact identifier
unii: XF417D3PSL
TopCare IbuprofenIBUPROFENTopco Associates LLC66097f19-227c-4f9c-a7f3-ab8476e1bb6e2025-04-08WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENMajor Pharmaceuticals14f43c32-0895-4ef2-aa54-52b952d058fd2025-04-08WarningsExact identifier
unii: WK2XYI10QM
parents choice infants ibuprofenIBUPROFENWal-Mart Stores Inca826d6cc-f582-4508-897d-0d637de0666c2025-04-07WarningsExact identifier
unii: WK2XYI10QM
leader infants ibuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderb72fdf65-8112-4d8b-b86f-8e17a40ee8e62025-04-07WarningsExact identifier
unii: WK2XYI10QM
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIea2ba726-0199-42ae-9c60-4b068df35e642025-04-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31f59d10-d821-2291-e063-6294a90ac5182025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31f61d5c-a3a3-3d47-e063-6394a90afb622025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN AND IBUPROFENDr. Reddy's Labortories Inc3e65c8a3-498e-1a2a-bb76-18e28ae2c73c2025-04-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31e6005b-492e-7936-e063-6394a90ad8012025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31e6ac7a-fa3e-4dd4-e063-6294a90a29af2025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENBryant Ranch Prepackb303b554-c457-4f2b-9931-48f30943178b2025-04-03WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENBryant Ranch Prepack87c9f15f-1196-477c-b5d2-3b875bea61d02025-04-03WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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