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 57 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENSpirit Pharmaceutical LLCa96d012e-b132-4e99-b84b-ccd3a9a05cbb2024-12-30WarningsExact identifier
unii: WK2XYI10QM
Cabinet Pain Reliever and Fever ReducerIBUPROFENSpirit Pharmaceutical LLCe172a8d8-779d-4ad9-b6b0-08a198a580342024-12-30WarningsExact identifier
unii: WK2XYI10QM
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedADVIL PMLil Drug Store Products, Incd1138e15-8ae4-7b49-e053-2995a90a96072024-12-30WarningsExact identifier
unii: WK2XYI10QM
Advil Liqui-GelsIBUPROFEN CAPSULE, LIQUID-FILLEDLil' Drug Store Products, Inc.c459ea1e-dabf-bba6-e053-2995a90af40f2024-12-30WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLC09bd3935-526d-4ad1-898a-4f0d9499ebb92024-12-26WarningsExact identifier
unii: WK2XYI10QM
Aacetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENGRANULES USA, INC.1dd90684-6505-8e07-e063-6394a90afdf42024-12-26WarningsExact identifier
unii: WK2XYI10QM
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: C151H8M554
Tucks Triple Relief HemorrhoidalWHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEBlistex Inc.bf892e90-2d9b-4fa0-8ee4-8a2736be6c302024-12-24WarningsExact identifier
unii: PDC6A3C0OX
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.4e15f6ca-a40c-485f-be3f-07c2ed7cb4982024-12-23WarningsExact identifier
unii: PDC6A3C0OX
Childrens Ibuprofen Oral SuspensionIBUPROFENChain Drug Marketing Association, Inc.f0959369-890e-403e-8a98-4eda340a07832024-12-23WarningsExact identifier
unii: WK2XYI10QM
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENSpirit Pharmaceutical LLC9a93d4a8-07a1-4ac5-9bd9-5d5e4e62c2af2024-12-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc.5398f5b7-a9a6-4f7e-a06c-e524b99395622024-12-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.fe939219-d752-63a0-e053-6394a90a0ab22024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
unii: PDC6A3C0OX
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENQuality Care Products, LLC246b120e-3458-4721-bf95-82537feaa1312024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENQuality Care Products, LLC56f1d6a9-6804-4235-a600-f7c8e458f6932024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
unii: XF417D3PSL
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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