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 312 of 317 · 6,330 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Cough ReliefDEXTROMETHORPHAN POLISTIREXSafewayf95d0519-e96b-45fe-974c-8fe6b9b8c88c2021-07-13WarningsExact identifier
unii: 9D2RTI9KYH
basic care mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINAmazon.com Services LLCac01ad52-483a-4cce-9279-51ceecada9b92021-07-13WarningsExact identifier
unii: 9D2RTI9KYH
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Decongestant PE Non DrowsyPHENYLEPHRINE HCLAllegiant Health7a3098b4-381c-4f32-97a7-87b53fd644282021-06-16WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Pain Relief Extra StrengthACETAMINOPHEN 500MGAllegiant Health0f72be92-fac0-4be4-87a3-3f20f0f01db52021-05-17WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Immediate ReleaseGUAIFENESIN 400MGGood Sensee7c68746-7ec0-46cf-b4a3-174fab819b5e2021-05-05WarningsExact identifier
application number: M012
AcetaminophenACETAMINOPHENWestminster Pharmaceuticals, LLCace5ebac-ec11-4c26-b1e3-954b450ee6712021-05-04WarningsExact identifier
unii: 362O9ITL9D
phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEGland Pharma Limited6486d284-5189-4000-aa7d-67150e84a7b22021-04-14Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
basic care childrens cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLC5b7c2306-ad87-48b0-99b7-71427907db0c2021-03-23WarningsExact identifier
unii: 9D2RTI9KYH
basic care cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLCa0f35883-9dd3-49e7-87ac-ce04561ad6c32021-03-09WarningsExact identifier
unii: 9D2RTI9KYH
Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATELGM PHARMA SOLUTIONS, LLC180d20a5-78a8-4faa-98ad-3196cdd5663a2021-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Mucus Relief Immediate ReleaseGUAIFENESIN 400MGTopCo Associates, LLC7d91c6ab-d161-42b9-b353-0aa8f59619f82021-01-21WarningsExact identifier
application number: M012
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEProficient Rx LPed9399e2-2be8-4793-99c5-204779c2a4712021-01-01Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENProficient Rx LP1ad89537-3e59-438c-b646-b3c93b7908532021-01-01Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP50be5d00-758e-4d01-8e78-40a60dbe67e52021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEProficient Rx LP1bde13a5-cdd4-4bc2-8aeb-32e4dc1572932021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPbab189ed-ff83-453c-a243-7ff052b2e4912021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and CodeineACETAMINOPHEN AND CODEINEProficient Rx LP2472bb8a-88b7-4eec-8806-34adef0c9ab92021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.943638b7-527b-4724-a6b7-2018862396d42020-11-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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