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 98 of 152 · 3,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENCVS Pharmacy6f880abe-5284-42b0-9db6-b071444b197b2024-12-27WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC.1608b4f0-bf20-4024-b8f2-20a4df7a4b212024-12-26WarningsExact identifier
unii: 362O9ITL9D
Aacetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENGRANULES USA, INC.1dd90684-6505-8e07-e063-6394a90afdf42024-12-26WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCcfc7eac3-35be-4002-b8ef-be1dfc8caf692024-12-26WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCa3031139-4709-43f2-95a8-89840c595f7f2024-12-26WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGWALGREENS CO.98bb28ed-d146-ca3d-e053-2a95a90a9eaf2024-12-26WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mgACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MGWALGREENS CO.982faa74-d498-cd1e-e053-2995a90afa1e2024-12-25WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.d88e04c1-cd54-6a12-e053-2995a90a22b42024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.11bf6e1b-aed9-4f8f-9f03-ea911ae9f7022024-12-23WarningsExact identifier
unii: 362O9ITL9D
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
Rugby Regular Strength AcetaminophenACETAMINOPHENRUGBY LABORATORIES295b0d00-4d4a-405f-9325-d01c5d4f3ed42024-12-20WarningsExact identifier
unii: 362O9ITL9D
Equate Childrens Multi symptom Cold NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee2024-12-20WarningsExact identifier
unii: 362O9ITL9D
Childrens TussnexACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company19e9678d-ac34-4af8-a80f-d08fce0a5f0e2024-12-19WarningsExact identifier
unii: 362O9ITL9D
Tussnex FM Cold, Flu and Sore ThroatACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company7bddce11-c227-4d95-94c1-6f41ecd7285b2024-12-19WarningsExact identifier
unii: 362O9ITL9D
Tussnex FM Cold and SinusACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company04c6bb6a-d2f8-4322-afba-e240e80901762024-12-19WarningsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENQuality Care Products, LLC53941807-072e-4783-819d-106ea904eda22024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENQuality Care Products, LLCe7d36246-9c80-49b6-ad4b-e38c3fd6d0682024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack3fe91e9f-4033-4b48-b51b-7eb67d40fa3a2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEPreferred Pharmaceuticals Inc.91e50642-d278-47c6-944b-4ed907e87e6b2024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
NOTTS - Muscle Aches and PainACETAMINOPHENVIVUNT PHARMA LLCe6741300-4573-2580-e053-2a95a90a599c2024-12-17WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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