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 154 of 155 · 3,092 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Multi-Symptom Night-timeACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCIAllegiant Health3f020cf2-6011-4216-9b39-0b3dc5f0749c2018-12-26WarningsExact identifier
unii: 362O9ITL9D
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-DrowsyACETAMINOPHEN AND PHENYLEPHRINE HCLAllegiant Healthb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f2018-12-21WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENTIME CAP LABORATORIES, INC2569383a-4a05-4ddb-852e-b37e487ffcde2018-12-17WarningsExact identifier
unii: 362O9ITL9D
Comfort-TimeACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATETime Cap Labs, Ince94a26a2-36e5-4e1e-aea1-24e035c980432018-12-14WarningsExact identifier
unii: 362O9ITL9D
Severe Cold Head CongestionACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMarc Glassman, Inc.3a774544-1994-4a93-9da9-06e55b1a83c82018-12-13WarningsExact identifier
unii: 362O9ITL9D
Clear Choice Regular Strength Pain RelieverACETAMINOPHENAthlete's Needs, Inc.d0d9fda5-5eba-4d51-b505-e93a2ae0bdd72018-12-11WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWalgreen Companya1cec332-5802-4684-8b7f-6cb98da40e8b2018-08-15WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.6e153073-ca78-481e-9e9c-0365ee3f3d592018-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN PMVelocity Pharmac1c1de91-6a54-4d91-93a9-b6be6d7c7dfb2018-05-14WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENVelocity Pharma LLCbba2ddc5-19e0-4f11-8ff7-7dd7c2d53b502018-05-14WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENCamber Pharmaceuticals, Inc.2a49ee34-6f1d-4ed3-8daa-343723d2a2be2018-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Childrens Multi-symptom Cold and Fever LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.7bf30c75-e867-4a2f-a481-702d7aa96c232018-01-08WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENAdvance Pharmaceutical Inc.3793a17e-13bf-4d27-b8fa-6753b760f8202017-12-22WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN PMACETAMINOPHEN PMAdvance Pharmaceutical Inc.b172226e-8f2a-4d9c-b7c7-dd737b90463a2017-12-22WarningsExact identifier
unii: 362O9ITL9D
APAPACETAMINOPHENAdvance Pharmaceutical Inc.aba26f0a-94e4-4919-a3b0-033e3a9598ef2017-12-22WarningsExact identifier
unii: 362O9ITL9D
APAPACETAMINOPHENAdvance Pharmaceutical Inc.5c75dc7f-06ae-440e-90ed-d7753eaa786e2017-12-22WarningsExact identifier
unii: 362O9ITL9D
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Healthb431a1a3-39c4-4d6c-afdc-c8b017ad89da2017-11-16WarningsExact identifier
unii: 362O9ITL9D
Extra Strength AcetaminophenACETAMINOPHENPuraCap Pharmaceutical LLCf3c57374-1408-4459-a4de-ad12c2fc6b612017-11-09WarningsExact identifier
unii: 362O9ITL9D
Extra Strength AcetaminophenACETAMINOPHENCVS PHARMACY, INC.3f9c230b-e6ea-4786-992b-9c72044252092017-11-09WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRichmond Pharmaceuticals, Inc.cda8e158-01ac-4c08-826e-4a0c7278e8052017-10-30WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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