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 113 of 152 · 3,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENKROGER COMPANYb9b63c38-83e7-62d2-e053-2a95a90a55262024-10-19WarningsExact identifier
unii: 362O9ITL9D
sinus pressure and pain peACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa7931e4c-8a5e-66e2-e053-2995a90af2a42024-10-18WarningsExact identifier
unii: 362O9ITL9D
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense570ea130-6a99-446e-9f97-14fc958090062024-10-18WarningsExact identifier
unii: 362O9ITL9D
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa14999e3-a9d9-0a1f-e053-2995a90af7b32024-10-18WarningsExact identifier
unii: 362O9ITL9D
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa793000b-3ef9-5662-e053-2a95a90ad0da2024-10-18WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENGoodSenseda4339c0-1822-41d8-8c20-214c379a5aa72024-10-18WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
Head Congestion Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEe3396a27-8643-71fa-e053-2a95a90a713d2024-10-18WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEGoodSense8972d95a-51da-40b5-8ef1-9dfed220d7eb2024-10-18WarningsExact identifier
unii: 362O9ITL9D
Head Congestion Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEe3397f69-3267-ca0b-e053-2995a90a7db52024-10-18WarningsExact identifier
unii: 362O9ITL9D
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense747512a2-3b6d-496b-ab80-8190603141632024-10-18WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Regular StrengthACETAMINOPHENAmeriSource Bergend571f520-a56e-4f7f-9214-d89197f742b62024-10-18WarningsExact identifier
unii: 362O9ITL9D
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAMERISOURCE BERGEN9daf7f40-d9c5-4367-be41-894208358fc12024-10-18WarningsExact identifier
unii: 362O9ITL9D
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen608e6808-29e4-40bc-8496-24c092681a1b2024-10-18WarningsExact identifier
unii: 362O9ITL9D
Cold Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen665db127-ee04-46c4-bff0-e0fe9950c3e22024-10-18WarningsExact identifier
unii: 362O9ITL9D
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen604d7e53-4bfd-4cdd-aed2-b304ae82ce442024-10-18WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENBurel Pharmaceuticals, LLC0a8a6a16-b23f-45d2-b5d4-540264e74d142024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
dg health pain reliefACETAMINOPHENDolgencorp Inc2e1470f5-e88f-4d1d-a308-170f7080387e2024-10-17WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART146c735b-5081-4de4-9025-d939d560bbba2024-10-17WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART62c35320-87b5-46e2-9f6f-cb0882bdb52e2024-10-17WarningsExact identifier
unii: 362O9ITL9D
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe3dcf6cf-373c-ea83-e053-2a95a90ae57a2024-10-17WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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