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 118 of 328 · 6,543 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Members Mark Arthritis PainACETAMINOPHENSam's West Inc4cbe2880-fea9-4d7b-9e7f-a0c794864a842025-12-23WarningsExact identifier
unii: 362O9ITL9D
Childrens Chest Congestion Relief GrapeGUAIFENESINDiscount Drug Mart3e5d245f-515c-4106-a855-fb97681b646a2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ed16-86bb-3faf-e053-2995a90acfbc2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCa7999da7-148a-4c6d-a2ea-0f4cc1d5b2832025-12-23WarningsExact identifier
application number: M012
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLCd8fe4ae4-bd19-42eb-b74d-f302b3f914ee2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLC11e6ec2a-5171-4496-a15f-6ff744bd1f2f2025-12-23WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAurolife Pharma, LLC69df20d9-b1d5-47dc-9ff0-29987284f8c72025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLCd4caec6d-4af2-4f1c-9add-c0c948b83b162025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAurolife Pharma, LLC02386806-02d4-47e3-9c8b-7810146ee7952025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Safetussin High Blood Pressure and diabetes Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES279e309c-040d-4001-808d-b7d986a9a1d82025-12-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Sinus PE Head Congestion and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED76fd1f8e-2670-421c-a9e6-c8adefb7962e2025-12-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINHanlim46851e7c-8910-6456-e063-6394a90abafb2025-12-22WarningsExact identifier
unii: PDC6A3C0OX
Leader Cough Drops Vanilla HoneyMENTHOLCardinal Health 110, LLC. DBA Leader1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e22025-12-22WarningsExact identifier
application number: M012
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYCardinal Health 110, LLC. DBA Leader26cd146a-6461-604f-e063-6394a90ac36e2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CREAMY STRAWBERRYMedical Group Care LLC043a5e11-30c3-44cd-e063-6394a90a318b2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CHERRYMedical Group Care LLC29f3f6dd-751e-1dfe-e063-6394a90a0dbb2025-12-22WarningsExact identifier
application number: M012
MGC Cough DropsMENTHOLMedical Group Care LLC437f6b77-ecf8-2cd8-e063-6394a90ad45d2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEYMedical Group Care LLCf4a92a69-e562-1cec-e053-2a95a90a01652025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS VANILLA HONEYMedical Group Care LLC043999bc-3efe-5d29-e063-6294a90a95f42025-12-22WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINMedical Group Care LLC3fa195b5-0712-aada-e063-6394a90a90692025-12-22WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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