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 116 of 152 · 3,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLD FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f960566-0158-6637-e053-2995a90a9c4a2024-10-15WarningsExact identifier
unii: 362O9ITL9D
HEAD CONGESTION PLUS FLU SEVERE PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.e65cf21d-3d69-a53e-e053-2a95a90a1c832024-10-15WarningsExact identifier
unii: 362O9ITL9D
night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH E B49f5f4d3-556c-4ee3-b5cd-5331dd434bb92024-10-15WarningsExact identifier
unii: 362O9ITL9D
Infants Pain and FeverACETAMINOPHENWalgreen Company9e08eb38-7538-4fa0-a0e1-047ab6cb16802024-10-15WarningsExact identifier
unii: 362O9ITL9D
Childrens Plus Cough and Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ea059b56-dc9a-4a6b-8c16-5dfcdaf4cd432024-10-14WarningsExact identifier
unii: 362O9ITL9D
pain reliefACETAMINOPHENPUBLIX SUPER MARKETS INC9e779cc6-4641-6132-e053-2a95a90a34932024-10-11WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENCHAIN DRUG CONSORTIUM5c1a3081-ae25-4895-bf76-ebcbb9fc80722024-10-11WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENMEIJER DISTRIBUTION INC9586e830-a285-4a07-8b34-9698754423482024-10-11WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association68a52858-35c5-402a-8ceb-8d8a7c1e5f6c2024-10-11WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
arthritis pain reliefACETAMINOPHENMeijer9f03fdb0-7dc0-376e-e053-2995a90ace052024-10-11WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association5de40821-3218-4320-bf11-9493bf01d4892024-10-11WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association475becec-1a56-4cfa-a0c5-562f8772adfb2024-10-11WarningsExact identifier
unii: 362O9ITL9D
8 Hour Pain ReliefACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC1da0bd23-9f26-4913-9ebf-1fd8b0fb3bd32024-10-11WarningsExact identifier
unii: 362O9ITL9D
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association1b4e87f8-3f9e-4865-9128-527d2d6215932024-10-11WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCff433512-55b7-4fc9-8a55-aff5cbb749ef2024-10-11WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC3170354a-4752-49a0-97ed-3d9db266a0592024-10-11WarningsExact identifier
unii: 362O9ITL9D
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS Pharmacy6c7b0ea6-bff9-4fd2-9e00-64015c326ee82024-10-11WarningsExact identifier
unii: 362O9ITL9D
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMeijer Distribution Incdcc12bc2-4bb4-4d2d-8206-b9db9843ec8b2024-10-11WarningsExact identifier
unii: 362O9ITL9D
Topcare Pain ReliefACETAMINOPHENTopco Associates LLC6036c15b-1168-4103-9471-6a74a2140e532024-10-10WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
Rompe Pecho NT NTACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEEfficient Laboratories Inc06faafaa-50a6-c16e-e063-6294a90a49cb2024-10-08WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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