FDA.reportPublic FDA data

NDC 58602-803-83 - Ibuprofen and Pseudoephedrine HCl

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
58602-803
Requested NDC
58602-803-83
Package NDCs from labels
58602-803-83, 58602-803-67, 58602-803-08, 58602-803-79, 58602-803-13, 58602-803-03
Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma Limited
Effective date
2022-01-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IBUPROFEN - Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma LimitedAurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma Limited2022-01-21Human OTC Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-803-03Ibuprofen and Pseudoephedrine HCl1 in 1 CARTONCAPSULE, LIQUID FILLED16
58602-803-08Ibuprofen and Pseudoephedrine HCl4 in 1 CARTONCAPSULE, LIQUID FILLED46
58602-803-13Ibuprofen and Pseudoephedrine HCl4 in 1 CARTONCAPSULE, LIQUID FILLED46
58602-803-67Ibuprofen and Pseudoephedrine HCl2 in 1 CARTONCAPSULE, LIQUID FILLED26
58602-803-79Ibuprofen and Pseudoephedrine HCl8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED86
58602-803-83Ibuprofen and Pseudoephedrine HCl10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-803IBUPROFEN AND PSEUDOEPHEDRINE HCL CAPSULE, LIQUID FILLED [AUROHEALTH LLC]6Current NDC, Legacy NDC, 6 package rows20220208_6adf9292-b4af-4cb4-99f3-dda03734570a.zip

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 3 of 75 · 1,495 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENShield Pharmaceuticals Corp22102461-0196-4ef0-aef4-66997d74d1182026-08-10WarningsExact identifier
unii: WK2XYI10QM
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Ibuprofen minisIBUPROFENWalgreens6d1d131d-0741-4a75-8383-9322f4f3faab2026-08-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corp216e5600-56b4-44b0-88b7-69adfb2458022026-08-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCOSTCO WHOLESALE CORPORATION4b8ad98e-de76-4f49-3b89-01e9dd5cde162026-08-06WarningsExact identifier
unii: WK2XYI10QM
Dye Free IbuprofenIBUPROFENWalgreen Companyd3d093f9-207a-40d4-a7be-c6b5a544a0a72026-08-06WarningsExact identifier
unii: WK2XYI10QM
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
IbuprofenIBUPROFENP & L Development, LLC159b68b7-54e5-4f83-b632-f49e7b4b14a52026-08-05WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWalgreen Companyc118b290-f821-4e73-906e-8a93edaf34e42026-08-05WarningsExact identifier
unii: WK2XYI10QM
foster and thrive mucus relief dGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC12460719-ff39-49b3-95f8-85e547ad00762026-08-04WarningsExact identifier
unii: 6V9V2RYJ8N
Dye Free IbuprofenIBUPROFENWalgreen Company8944a0e8-2928-4494-915f-d1e0a6d4bf5c2026-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.560e4e05-21e0-4b2a-ab2f-872b5dbb39012026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.733d0b21-c177-4c60-9243-2f1e7cb5854a2026-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC8abd74a4-ad33-4c10-b677-acb469f815e62026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC291602fa-8ebe-4200-bba7-9798c90f8a502026-08-03WarningsExact identifier
unii: WK2XYI10QM
Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HCLMeijer Distribution Inc383281d7-0d25-4423-ace2-d2985f2c37d02026-08-03WarningsExact identifier
unii: 6V9V2RYJ8N
IbuprofenIBUPROFENNUVICARE LLCb063d2dc-d579-46e7-8cfc-1596c803c7f92026-08-03WarningsExact identifier
unii: WK2XYI10QM
LEADER 12HR ALLERGY AND CONGESTION RELIEFFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader1400014a-2fa6-4a4f-8eb9-85ac049b4b702026-08-03WarningsExact identifier
unii: 6V9V2RYJ8N
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.af18ca44-615e-48ef-b678-7a9ae02e0f2a2026-08-03WarningsExact identifier
unii: 6V9V2RYJ8N
EQUATE ALLERGY RELIEF DFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEWALMART INC.6daeb739-a112-4a37-abbb-0bbc41b42df32026-08-03WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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