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 145 of 151 · 3,017 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Children Pain ReliefCHILDREN PAIN RELIEFAllegiant Health44c90cbe-8ece-4dd8-9ea5-7f8d6f4c00962023-07-17WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULESLannett Company, Inc.4d62259d-a582-4621-b62e-3d5640cadf7c2023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 368GB5141J
Dual ActionACETAMINOPHEN, IBUPROFENKROGER COMPANYee0ae5e6-388d-0085-e053-2a95a90add8e2023-07-12WarningsExact identifier
unii: 362O9ITL9D
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 368GB5141J
New Hanbang Col CapACETAMINOPHEN, CAFFEINE ANHYDROUS,Lydia Co., Ltd.e9dbbbcd-9ab7-aa10-e053-2995a90acd242023-07-10WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEQUAGEN PHARMACEUTICALS LLC5f3c7457-6670-4a0d-bdff-c3e0fe91b7c62023-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
NOCOLD-SACETAMINOPHEN, CHLORPHENIRAMINE MALEATELydia Co., Ltd.f2e951c9-afac-7e2e-e053-2a95a90a50202023-07-05WarningsExact identifier
unii: 362O9ITL9D
Arthritis PainACETAMINOPHENBETTER LIVING BRANDS, LLCee84323a-b615-3ec6-e053-2995a90a5a262023-06-15WarningsExact identifier
unii: 362O9ITL9D
8 Hour Pain ReliefACETAMINOPHENSTRATEGIC SOURCING SERVICES LLCc003a34a-bfe5-4298-8a4e-8c75576f56742023-06-09WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEBryant Ranch Prepack90e166ac-8789-4e7a-b5bb-37c475e3a5b02023-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
DG health dual pain relieverACETAMINOPHEN, IBUPROFENDolgencorp Inc464d436a-79b0-45b4-8b5f-51dc2de2d8e42023-05-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENB. Braun Medical Inc.6d763554-913d-4bed-9efd-b9c9b936a2f42023-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
eight hour pain reliefACETAMINOPHENUnited Natural Foods, Inc. dba UNFIb5fe8873-13c9-402e-b06c-6e679af7267e2023-05-17WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN ASPIRIN AND CAFFEINEACETAMINOPHEN, ASPIRIN AND CAFFEINEAurohealth LLCe47e2169-4b31-4c23-bb9d-c26aa106ea372023-05-11WarningsExact identifier
unii: 362O9ITL9D
pain reliever fever reducer childrensACETAMINOPHENWalgreen Companyf2085b26-5778-4656-8de3-9edd83f914dd2023-05-03WarningsExact identifier
unii: 362O9ITL9D
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEAAA PHARMACEUTICAL, INC.f9c9a0b4-dbfe-7da9-e053-6294a90a7e092023-05-03WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWG Critical Care, LLC60f0d5b2-cab4-4a7c-8b53-1526a0908a542023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
8 hr Arthritis Pain ReliefACETAMINOPHENDOLGENCORP, INC.ea2eae7c-e9bd-534c-e053-2a95a90a26c82023-04-20WarningsExact identifier
unii: 362O9ITL9D
8 hr Pain ReliefACETAMINOPHENDOLGENCORP, INC.ea2ebb7b-ceab-567a-e053-2995a90aa4022023-04-20WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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