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 317 of 317 · 6,330 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRONCOCHEM ALLERGY CONTROLCHOLPHENIRAMINE MALEATE-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLec5a216c-6827-4de3-8683-ff04e726ff6f2017-03-14WarningsExact identifier
unii: 04JA59TNSJ
Acetaminophen CapletsACETAMINOPHENBreeden Brothers, LLC57fff3dc-ba30-4d3d-9362-01df6974f8132017-02-15WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLChain Drug Consortium,LLC47f839b9-ac8a-161c-e054-00144ff8d46c2017-02-07WarningsExact identifier
unii: 362O9ITL9D
Cold MedicineACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLSelder, S.A. de C.V.d2762d9c-e7e7-42b2-a26a-14b2aa0307cb2017-01-25WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
SED-MAXACETAMINOPHEN 500 MG WITH CAFFEINE 65MGCommand Brands, LLC4920a0e9-6f88-4df0-8657-77c95a3b96172017-01-19WarningsExact identifier
unii: 362O9ITL9D
AllergyCHLORPHENIRAMINE MALEATEMarc Glassman, Inc.2051247f-ce64-4cf5-b449-9ca14c43ab862016-12-27WarningsExact identifier
application number: M012
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLd0426469-9dd1-4bd1-b81e-69d33187daa22016-12-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL8aa32b2a-a8be-4f8d-9b1f-eb007bff8e652016-12-19WarningsExact identifier
unii: 9D2RTI9KYH
CVS Health Four Actions Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECVS Pharmacy,Inc.c91b5525-6afb-4fea-afcb-9c45780759752016-09-22WarningsExact identifier
unii: 04JA59TNSJ
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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