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 24 of 328 · 6,543 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp772d0184-8c41-40f1-bbef-7e68692eec662026-07-22WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
good sense allergyDIPHENHYDRAMINE HCLL. Perrigo Companybf5039a0-2109-41a2-84a9-b5167d0a93da2026-07-22WarningsExact identifier
application number: M012
GOOD SENSE INFANTS PAIN AND FEVERACETAMINOPHENL. Perrigo Companya7cc3964-e8fa-41da-89ca-b0d2aa80f2a72026-07-22WarningsExact identifier
unii: 362O9ITL9D
Congestion and HeadacheACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY432c3ec4-7595-4213-94e3-ce41af91804e2026-07-21WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDECardinal Health 107, LLC6d59ee85-08e5-452d-a09a-35fcc2a82b752026-07-21Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
SKAPEMED ORIGINAL NASALNAPHAZOLINE HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a208a1f-f6e8-0b4a-e063-6294a90a10c82026-07-21WarningsExact identifier
application number: M012
SERYNTH FAST RELIEF NASALNAPHAZOLINE HCL 0.05% FAST RELIEF NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4abdc0-aded-1b8a-e063-6394a90a9b562026-07-21WarningsExact identifier
application number: M012
DERMFREE ORIGINAL NASALNAPHAZOLINE HCL0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4d0c03-7d8f-76cb-e063-6394a90a938c2026-07-21WarningsExact identifier
application number: M012
DERMFREE ORIGINAL NASALNAPHAZOLINE HCL 0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4d3a2b-a4ed-c736-e063-6394a90a96df2026-07-21WarningsExact identifier
application number: M012
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Severe Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY791eaac1-ddb5-40e2-9040-52dfadc30e062026-07-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Childrens AcetaminophenACETAMINOPHENCardinal Health 107, LLC7562f4e4-54fa-488c-a199-48ad2632e2a12026-07-21WarningsExact identifier
unii: 362O9ITL9D
DRx Choice DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERaritan Pharmaceuticals Inc.9ab47b10-b1ed-4ae1-94e8-09d50e952bb02026-07-21WarningsExact identifier
application number: M012
rxcui: 1086997
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLP & L Development, LLC17639c3b-5d36-41f5-bd0d-da29075abd092026-07-21WarningsExact identifier
application number: M012
MedlineACETAMINOPHENMedline Industries, LP4b1d7243-b943-4e2b-e063-6294a90a2c4e2026-07-20WarningsExact identifier
unii: 362O9ITL9D
NATUHEAL ORIGINAL NASALNAPHAZOLINE HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a470b9e-c83f-fb20-e063-6294a90a2f132026-07-20WarningsExact identifier
application number: M012
Vamy HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD499197aa-f872-3abf-e063-6294a90aeda22026-07-20WarningsExact identifier
unii: 04JA59TNSJ
TYLENOL Cold plus Flu Multi-Symptom Liquid Gels DayACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC1c444202-19e9-8d04-e063-6394a90a92942026-07-20WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONDISCOUNT DRUG MART5565a581-e2b5-81a5-e063-6394a90af4092026-07-20WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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