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 151 of 155 · 3,092 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP484a4323-0758-439d-844f-f04d7e5ef6f32022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
basic care migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmazon.com Services LLCa19798b3-1b2e-4e4f-b595-2a156bd52ee52022-07-28WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.23dde6b8-3655-49ee-ac2c-28f80cf6b3c22022-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENHikma Pharmaceuticals USA Inc.b466c989-f7aa-e476-e053-2a95a90a8e552022-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
topcare migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINETopco Associates LLC9163ecfe-6493-46eb-a08d-b4134d84b0ab2022-06-28WarningsExact identifier
unii: 362O9ITL9D
dg health migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp Inc673d42d8-b484-4232-bc91-19d83db635502022-06-07WarningsExact identifier
unii: 362O9ITL9D
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENProficient Rx LPd9fa3057-c7a5-46cf-a79e-abf99a4f804d2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
topcare 8 hr arthritis pain reliefACETAMINOPHENTopco Associates LLC0d427360-ff9d-4e98-b218-6eb6c015dc6a2022-05-23WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.5c00f98f-dcab-4bdb-901e-02eb873dea312022-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.3e89f02d-b6e7-4641-82d4-f756518a89142022-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
TrezixACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEProficient Rx LP45c3c2a1-6a89-471e-b6d4-5a4cd73b987a2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPc6210466-5feb-45d9-b637-b3f482bc3c2b2022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP199d4915-cb3b-48f3-835d-a45d04a5c9402022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP75b50751-5237-4e3e-b7ee-1605c0602f3b2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
basic care acetaminophenACETAMINOPHENAmazon.com Services LLCb0c55ac4-0b1a-4411-9df3-6bb64e20ea222022-03-23WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb3c229a4-c772-70fb-e053-2a95a90a72db2022-03-11WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENSolupharm Pharmazeutische Erzeugnisse GmbHd92be8ae-3173-0a9d-e053-2995a90abc632022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCivica, Inc.1b5ca3e0-ce08-4e11-9385-9ec22e5abb5b2022-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEProficient Rx LP7a2219a8-8aaf-44ad-9808-b67923df361a2022-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAsclemed USA, Inc.52693021-f60f-43bc-9b05-43db186213462022-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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