FDA.reportPublic FDA data

NDC 83558-021-01 - 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
Requested NDC
83558-021-01
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 154 of 323 · 6,448 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength AcetaminophenACETAMINOPHENNuCare Pharmaceuticals, Inc.41affa1a-5aac-7fc0-e063-6394a90a55572025-10-30WarningsExact identifier
unii: 362O9ITL9D
EndalTRIPROLIDINE HCL, DEXTROMETHORPHAN HBRPoly Pharmaceuticals, Inc.fc5401e2-ed65-72e7-e053-6294a90a81f32025-10-30WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRFamily Dollar (FAMILY WELLNESS)ebc1a915-f643-4878-9d7a-67a9c6a26b202025-10-30WarningsExact identifier
unii: 9D2RTI9KYH
daytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Incc7cef266-46fc-49ab-a2e7-54fc562986592025-10-30WarningsExact identifier
application number: M012
rxcui: 1086997
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRTarget Corporation15434143-ab8e-4cf9-e063-6394a90a23882025-10-30WarningsExact identifier
unii: 9D2RTI9KYH
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDESAM'S WEST INC16592ad7-b7cb-0837-e063-6394a90ae0592025-10-29WarningsExact identifier
application number: M012
Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLSAFEWAY013b94a1-26c7-4371-981a-d1b9d7fd1c982025-10-29WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Better LivingPHENYLEPHRINE HYDROCHLORIDEBETTER LIVING BRANDS LLCaea0db7f-e01a-4d8e-9c20-4a5ef4a905d12025-10-29WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
GlycerinGLYCERINChain Drug Marketing Association Inc.424d91f0-ecf9-6d9b-e063-6394a90a80062025-10-29WarningsExact identifier
unii: PDC6A3C0OX
MAPAP Extra StrengthACETAMINOPHENMajor Pharmaceuticals34a95450-3f04-4de4-9113-73e7bd5724a02025-10-29WarningsExact identifier
unii: 362O9ITL9D
AXIM DayTime - Night Time 72 SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLCde9eb2d5-ba51-4637-e053-2995a90a04512025-10-29WarningsExact identifier
application number: M012
rxcui: 2634564
rxcui: 1094549
rxcui: 1086997
Dollar General Vapor SteamCAMPHOR (SYNTHETIC)DOLGENCORP, LLC86d0f3ac-1359-c2f9-e053-2a91aa0a35d02025-10-29WarningsExact identifier
application number: M012
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
unii: PDC6A3C0OX
unii: 04JA59TNSJ
GOODNOW PAIN RELIEFACETAMINOPHENGobrands, Inc4d4a78a5-5a88-4f24-b685-c7c6bb5e989e2025-10-29WarningsExact identifier
unii: 362O9ITL9D
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRFamily Dollar (FAMILY WELLNESS)b60d1cc6-086c-4483-a101-c5f8d60009692025-10-29WarningsExact identifier
unii: 9D2RTI9KYH
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAmneal Pharmaceuticals of New York LLCe0cefc7b-e81c-4e15-89a0-fe71dc94338b2025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Maximum Strength Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWal-Mart Stores,Inc.,a748d5ab-901c-47bb-8437-997542ecebfe2025-10-28WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEWAL-MART STORES,INC.68a68574-0fcb-4569-be57-d9aee5f62bea2025-10-28WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Maximum Strength Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores,Inc.,635009a1-6154-4c62-a4be-d4f32c2cef8d2025-10-28WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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