FDA.reportPublic FDA data

NDC 79583-001 - Acetaminophen

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
79583-001
Package NDCs from labels
79583-001-01, 79583-001-02
Manufacturer
Rescuers Life sciences Limited
Effective date
2020-07-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acetaminophen - Rescuers Life sciences LimitedRescuers Life sciences Limited2020-07-20HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79583-001-012022-01-28C16284748780-1d6a99b39-ac24-a426-e053-dadaa90af4c2Acetaminophen Tablets USP 500 mg
79583-001-022022-01-28C16284748780-1d6a99b39-ac24-a426-e053-dadaa90af4c2Acetaminophen Tablets USP 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79583-001-01Acetaminophen100 in 1 BOTTLETABLET1001
79583-001-02Acetaminophen200 in 1 BOTTLETABLET2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79583-001ACETAMINOPHEN TABLET [RESCUERS LIFE SCIENCES LIMITED]12 package rows20200727_71bcfe9e-e9c8-4cf6-9e17-39fbdb8e3962.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 131 of 152 · 3,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)f9530d55-8226-4659-84f0-2c0b411572be2024-04-17WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and Fever Dye FreeACETAMINOPHENKROGER COMPANY0fec66b4-3a2a-63d1-e063-6294a90a6d722024-04-17WarningsExact identifier
unii: 362O9ITL9D
MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIMEACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MGRITE AIDc92dbbbb-d149-1e7e-e053-2a95a90a6f1a2024-04-17WarningsExact identifier
unii: 362O9ITL9D
MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIMEACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 15 MG DOXYLAMINE SUCCINATE 6.25 MGRITE AIDc9323799-3505-d6c1-e053-2995a90a6f432024-04-17WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)fac8b01a-9666-43cc-a4ff-3f3ed452c7e42024-04-17WarningsExact identifier
unii: 362O9ITL9D
8 Hour Pain ReliefACETAMINOPHENKROGER COMPANY0fec5c67-8d5d-8e45-e063-6394a90a982a2024-04-15WarningsExact identifier
unii: 362O9ITL9D
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENNavajo Manufacturing Company Inc.bd0d7812-4e42-b533-e053-2995a90ae1f92024-04-15WarningsExact identifier
unii: 362O9ITL9D
Handy Solutions Headache Pain ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENavajo Manufacturing Company Inc.e5481abe-6971-2bc5-e053-2995a90ae8952024-04-15WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLP & L Development, LLC8d27b94d-23a1-4e6c-a064-79e2580f7e2e2024-04-15WarningsExact identifier
unii: 362O9ITL9D
Severe Cold and Cough Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLP & L Development, LLC2af496a1-6fdd-4acf-9944-8b7cdf3022752024-04-15WarningsExact identifier
unii: 362O9ITL9D
childrens acetaminophenACETAMINOPHENMajor Pharmaceuticals243a5cff-e506-434b-ab19-1a6ac53f85332024-04-15WarningsExact identifier
unii: 362O9ITL9D
Dye Free Pain Reliever ChildrensACETAMINOPHENP & L Development, LLC45ddcaad-d416-4d7c-a84a-43548d5c5d3b2024-04-15WarningsExact identifier
unii: 362O9ITL9D
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.65bf1556-f25a-9439-e053-2a91aa0a31942024-04-15WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENKroger Companybbeebdd6-fe2c-5b8a-e053-2a95a90ab95e2024-04-13WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
infants pain reliefACETAMINOPHENPublix Super Markets Inc3d1818a7-d3b2-434c-b3c9-b2713f08ded22024-04-13WarningsExact identifier
unii: 362O9ITL9D
Mommys Bliss Childrens Pain and FeverACETAMINOPHENMom Enterprises, LLC.08b9eaf7-70d1-640f-e063-6394a90a8d3b2024-04-12WarningsExact identifier
unii: 362O9ITL9D
Mommys Bliss Infants Pain and FeverACETAMINOPHENMom Enterprises, LLC.05e26650-81b3-d7b1-e063-6394a90a14ed2024-04-11WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain ReliefCHILDRENS PAIN RELIEFAllegiant Health7381dd26-c507-4d02-b989-cfd96e02f4952024-04-11WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain Relief Dye-FreeACTEAMINOPHENWinCo Foods, LLC5ee134b3-b8e9-4621-b0a1-a84d9867ccba2024-04-11WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENWALGREENS0b1d086f-7be1-5072-e063-6394a90a11e62024-04-10WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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