FDA.reportPublic FDA data

NDC 59368-340 - welby 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
59368-340
Package NDCs from labels
59368-340-01
Manufacturer
Praxis, LLC
Effective date
2023-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
welby acetaminophen - Praxis, LLCPraxis, LLC2023-01-01HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-340WELBY ACETAMINOPHEN (ACETAMINOPHEN) TABLET [PRAXIS, LLC]1Unmatched20250330_3158acca-5bfe-072c-e063-6394a90ae840.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 149 of 155 · 3,092 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dual ActionACETAMINOPHEN, IBUPROFENKROGER COMPANYee0ae5e6-388d-0085-e053-2a95a90add8e2023-07-12WarningsExact identifier
unii: 362O9ITL9D
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
HEBACETAMINOPHENHEB96b1808f-defa-28cb-e053-2995a90a563b2023-04-12WarningsExact identifier
unii: 362O9ITL9D
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack3875c01b-7cd6-4bed-8d4e-c580c55408602023-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Arthritis Pain ReliefACETAMINOPHENWINCO FOODS, LLCf45f43da-b994-2bc8-e053-2995a90a93e02023-04-11WarningsExact identifier
unii: 362O9ITL9D
DG Health migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp, LLCd0e82cac-dfbb-49cb-99c8-560b02fb1a8c2023-04-05WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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