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 117 of 152 · 3,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma46d9d8cd-e3db-492c-9386-7e8255beff642024-10-08WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack59a92d79-5b2d-4c10-b0ac-ea766a0ff08b2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.19ba1fb6-22ea-488e-9e52-94c14ceb80d12024-10-07WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENBryant Ranch Prepackf6dc5576-9ba3-436c-87f5-8d0d6258adef2024-10-07WarningsExact identifier
unii: 362O9ITL9D
Cramp TabsACETAMINOPHEN, PAMABROM, AND PYRILAMINE MALEATEJHK DBA American Safety & First Aidc090807d-03b7-42d4-be41-f6240a3b330f2024-10-04WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack2ad2d00e-3796-4605-852f-a3d64d5ef09f2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDENavajo Manufacturing Company Inc.f6068011-ad56-59b4-e053-2995a90ac0162024-10-03WarningsExact identifier
unii: 362O9ITL9D
dual action pain relieverACETAMINOPHEN AND IBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.2397603c-8d87-2e65-e063-6394a90ab73e2024-10-03WarningsExact identifier
unii: 362O9ITL9D
dual action pain relieverACETAMINOPHEN AND IBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.23994b21-cbc2-5a34-e063-6394a90acfdf2024-10-03WarningsExact identifier
unii: 362O9ITL9D
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.86b6ac01-3866-4cd8-a1be-9babb6ff311b2024-10-02WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
childrens pain reliefACETAMINOPHENPublix Super Markets Incde7dd4dc-c5df-4cac-a83a-b21a7637f3392024-10-02WarningsExact identifier
unii: 362O9ITL9D
Good Neighbor Pharmacy childrens pain and feverACETAMINOPHENAmerisource Bergen6ba153b7-9dc9-4e42-9176-13b3922268bd2024-10-02WarningsExact identifier
unii: 362O9ITL9D
equaline acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFId418c676-03c3-4031-bbf4-8bf908d10e4c2024-10-02WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporationf6e51c4b-2941-4862-8262-bd97163248412024-10-02WarningsExact identifier
unii: 362O9ITL9D
Extra Strength PM Pain MedicineACETAMINOPHEN, DIPHENHYDRAMINE HCLAmerisource Bergen23fbda2b-885b-ce00-e063-6294a90a586e2024-10-01WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEProficient Rx LP3cf799b4-c785-4ae2-908b-c42e426733dc2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.1bec5167-5fc5-2405-e063-6294a90a53582024-09-30WarningsExact identifier
unii: 362O9ITL9D
Good Sense Pain ReliefACETAMINOPHENA-S Medication Solutionsd9bebb47-6ff4-4ddc-b48f-18f9423734842024-09-30WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
basic care acetaminophenACETAMINOPHENAmazon.com Services LLC24fca5f8-1c08-4d1f-8e2c-dc274c4bcd792024-09-29WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J

Reported adverse events (FAERS/openFDA)#

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