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 126 of 152 · 3,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.6f2ce909-6356-1c2c-e053-2a91aa0a01352024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.fa234639-caf8-4c52-9ffe-f1c0c057ee5b2024-06-10WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.bc18590d-6481-4efe-8a3b-974f7543b7542024-06-10WarningsExact identifier
unii: 362O9ITL9D
pain and feverACETAMINOPHENMeijer Distribution Inccbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf2024-06-07WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.5691ac45-5732-412e-abb8-2bfaac59160e2024-06-07WarningsExact identifier
unii: 362O9ITL9D
acetaminophen for childrenACETAMINOPHENNuCare Pharmaceuticals,Inc.5f86e792-3262-4ee6-e053-2991aa0a54a02024-06-06WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINETARGET Corporation611bc1ce-460a-44a3-8e2d-b28a399d9a442024-06-06WarningsExact identifier
unii: 362O9ITL9D
up and up daytime honey cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETarget Corporation29da4b94-8f8e-48e8-909f-8476e3b39d782024-06-06WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc033a6153-2651-4703-8a94-def4618381132024-06-05WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENBluePoint Laboratoriesc065c531-88f5-0930-e053-2a95a90ae8612024-06-05WarningsExact identifier
unii: 362O9ITL9D
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company126ee71a-c408-415b-9a43-502337a910552024-06-05WarningsExact identifier
unii: 362O9ITL9D
Tylenol Extra StrengthACETAMINOPHENA-S Medication Solutions85294a70-3233-4ba5-bc36-ee3f2964aebf2024-06-05WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D
acetaminophen for childrenACETAMINOPHENNuCare Pharmaceutiacals,Inc.5d7ef1d2-d970-7b01-e053-2991aa0a13112024-06-04WarningsExact identifier
unii: 362O9ITL9D
CareOne Infants AcetaminophenACETAMINOPHENAmerican Sales Company0a28a4f1-d947-489b-be28-36ba10b581cf2024-06-01WarningsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4a873428-bb5a-4e48-9185-2a27f289110d2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack88d05136-7b04-4b25-af1c-6bc72fdbcbd72024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack96173ce4-4836-43ae-9797-5246f830643a2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3791abd3-fcdf-4c8d-b46d-db6e5c8057702024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack0c85d1b8-ea42-421d-a305-4d338b47150f2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENBryant Ranch Prepack77fb237f-28b5-486b-b9ef-cb324d5cc0bd2024-05-30WarningsExact identifier
rxcui: 198440
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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