FDA.reportPublic FDA data

NDC 83558-021 - Day and Night Multi Symptom Cold and Flu Relief

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
83558-021
Package NDCs from labels
83558-021-01
Manufacturer
Intrivo Diagnostics Inc.
Effective date
2023-10-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Day and Night Multi Symptom Cold and Flu ReliefIntrivo Diagnostics Inc.2023-10-13HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83558-021-01Day and Night Multi Symptom Cold and Flu Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED105 mg2
83558-021-01Day and Night Multi Symptom Cold and Flu Relief1 in 1 CARTONCAPSULE, LIQUID FILLED5 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83558-021DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF KIT [INTRIVO DIAGNOSTICS INC.]2Unmatched20231114_a311bf39-de6c-4ed5-949e-718ad8be1e49.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 305 of 317 · 6,330 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULESLannett Company, Inc.4d62259d-a582-4621-b62e-3d5640cadf7c2023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 6DC9Q167V3
Dual ActionACETAMINOPHEN, IBUPROFENKROGER COMPANYee0ae5e6-388d-0085-e053-2a95a90add8e2023-07-12WarningsExact identifier
unii: 362O9ITL9D
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 6DC9Q167V3
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsee227c52-2cd8-4a06-a2de-a257f1f4732a2023-07-11Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
New Hanbang Col CapACETAMINOPHEN, CAFFEINE ANHYDROUS,Lydia Co., Ltd.e9dbbbcd-9ab7-aa10-e053-2995a90acd242023-07-10WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGEN PHARMACEUTICALS LLC5f3c7457-6670-4a0d-bdff-c3e0fe91b7c62023-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEBE Pharmaceuticals Inc.fb069778-d16e-40f9-9c02-5496adfcb5d22023-07-10Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
NOCOLD-SACETAMINOPHEN, CHLORPHENIRAMINE MALEATELydia Co., Ltd.f2e951c9-afac-7e2e-e053-2a95a90a50202023-07-05WarningsExact identifier
unii: 362O9ITL9D
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEParagon BioTeck, Inc.a4d3fe20-f063-11e0-ac29-0002a5d5c51b2023-06-29Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Arthritis PainACETAMINOPHENBETTER LIVING BRANDS, LLCee84323a-b615-3ec6-e053-2995a90a5a262023-06-15WarningsExact identifier
unii: 362O9ITL9D
8 Hour Pain ReliefACETAMINOPHENSTRATEGIC SOURCING SERVICES LLCc003a34a-bfe5-4298-8a4e-8c75576f56742023-06-09WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEBryant Ranch Prepack90e166ac-8789-4e7a-b5bb-37c475e3a5b02023-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions440d0554-995c-47df-b9f6-f3e3ce2e35e02023-06-06Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEMedical Purchasing Solutions, LLCd88a01c4-9681-2695-e053-2995a90a62ea2023-05-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DG health dual pain relieverACETAMINOPHEN, IBUPROFENDolgencorp Inc464d436a-79b0-45b4-8b5f-51dc2de2d8e42023-05-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENB. Braun Medical Inc.6d763554-913d-4bed-9efd-b9c9b936a2f42023-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
eight hour pain reliefACETAMINOPHENUnited Natural Foods, Inc. dba UNFIb5fe8873-13c9-402e-b06c-6e679af7267e2023-05-17WarningsExact identifier
unii: 362O9ITL9D
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.f2096e12-cbeb-4084-9132-17c7ef46b7b92023-05-16Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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