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 5 of 74 · 1,479 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
childrens ibuprofenIBUPROFENRite Aid Corporation26bccfc1-bc8d-4241-a078-c760048951c92026-07-24WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHF Acquisition Co LLC, DBA HealthFirst574b6f15-70bc-fca7-e063-6294a90a04552026-07-23WarningsExact identifier
unii: WK2XYI10QM
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDESportpharm LLCf3afca82-ba8f-4741-8332-b7939aa0ee5e2026-07-23Warnings, Adverse reactionsExact identifier
unii: 6V9V2RYJ8N
IbuprofenIBUPROFENSafeway, Inc.a530d43d-e9c4-4edb-af66-c92860e46f452026-07-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTWIN MED LLCf03958f8-aeae-edf0-e053-2a95a90a3e9e2026-07-22WarningsExact identifier
unii: WK2XYI10QM
Good Sense ibuprofenIBUPROFENL. Perrigo Companyaebae4b3-18c8-4ecf-b578-1fe7cc50076b2026-07-22WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.d3a7ebef-f7ab-4b34-b62e-278a8deabf782026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.b81c6495-8b30-41ef-8a0f-4cbfd87f1eb42026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d82026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENCVS Pharmacy52193849-d03a-b61b-e063-6394a90ad2772026-07-20WarningsExact identifier
unii: WK2XYI10QM
good sense dual actionACETAMINOPHEN, IBUPROFENL Perrigo Companyb117358c-f4ca-4ea8-95ee-88a42cc050402026-07-17WarningsExact identifier
unii: WK2XYI10QM
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
IbuprofenIBUPROFENREMEDYREPACK INC.57a1bf99-5aaf-432d-86ba-5f0e7cfab1a02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
LoHist DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.93c9ad4f-3376-48c2-8276-0375663acd012026-07-16WarningsExact identifier
unii: 6V9V2RYJ8N
ibuprofenIBUPROFENHyVee Ince7175dc9-db39-4452-a419-85af179de4222026-07-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENSun Pharmaceutical Industries, Inc.9de61620-6750-4fb6-89a4-fe451ab8d99f2026-07-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENStrides Pharma Science Limited38ebacc3-378f-483e-babc-76119677e7df2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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