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 2 of 75 · 1,495 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive dual actionACETAMINOPHEN, IBUPROFENStrategic Sourcing Services LLCf970d423-1d92-40c0-8358-91d1f963505c2026-08-26WarningsExact identifier
unii: WK2XYI10QM
Pain RelieverACETAMINOPHEN, IBUPROFENCVS Pharmacy9126e680-d5ff-4189-9f9a-d797822ce6702026-08-26WarningsExact identifier
unii: WK2XYI10QM
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2026-08-26WarningsExact identifier
unii: WK2XYI10QM
dual pain relieverACETAMINOPHEN, IBUPROFENWalgreen Company5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df2026-08-26WarningsExact identifier
unii: WK2XYI10QM
Infants IbuprofenIBUPROFENWalgreens3bbbe142-a00c-404b-a116-81ad730ea1302026-08-25WarningsExact identifier
unii: WK2XYI10QM
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC26f2c3c1-a2f2-474a-950a-8cfe07f289fa2026-08-25WarningsExact identifier
unii: 6V9V2RYJ8N
IbuprofenIBUPROFENMajor Pharmaceuticalsba86e936-ef72-43e5-aebf-f2c788fe22662026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
CombogesicACETAMINOPHEN AND IBUPROFENPreferred Pharmaceuticals Inc.f3cee991-19ef-4a1c-bb14-cbc8b6f327762026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSafeway, Inc.57f06daf-690d-44a7-95a5-4687329497502026-08-19WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENNuCare Pharmaceuticals,Inc.59554a62-3a9a-c0f3-e063-6294a90ad3fd2026-08-18WarningsExact identifier
unii: WK2XYI10QM
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
CHILDRENS IBUPROFENIBUPROFENAmazon.com Services LLC0865fe8a-df81-4ae4-8bed-29a022ba164f2026-08-17WarningsExact identifier
unii: WK2XYI10QM
Nasal Decongestant Maximum Strength, Non-DrowsyPSEUDOEPHEDRINE HCLAmerisource Bergen1fdb1ba5-4072-4baf-9e30-f01d57bf6d822026-08-15WarningsExact identifier
unii: 6V9V2RYJ8N
CHILDRENS IBUPROFENIBUPROFENAmazon.com Services LLC5ba08c30-7eb9-433b-b763-9288f4dd10122026-08-12WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENWALMART INC. (see also Equate)d86151b6-d5c5-4d93-9cfd-43ab7ad0443a2026-08-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAiPing Pharmaceutical, Inc.3e131710-2579-446e-8076-f602ecea813f2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
INFANTS IBUPROFENIBUPROFENAmazon.com Services LLC8588617a-d4b8-4ab5-8b87-30e6f1121cc32026-08-10WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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