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 148 of 155 · 3,092 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and Cough Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)553d01a9-e8ad-4797-b55b-32f134f08af92023-10-10WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens8781e2c5-ad46-4615-a0d9-879590e86f952023-10-10WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens419df833-1f33-45cf-bab3-730c928d58872023-10-10WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)93a5cb36-3262-4224-a5be-5ea1619a67bd2023-10-10WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever Extra StrengthACETAMINOPHENWalgreensb4b06d32-6a09-4c43-980b-377b617ba7392023-10-09WarningsExact identifier
unii: 362O9ITL9D
FLO PMS CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEO Positiv, Inc.cce62d9f-adb1-4473-8258-910dff6b13782023-10-09WarningsExact identifier
unii: 362O9ITL9D
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIXACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b2023-10-02WarningsExact identifier
unii: 362O9ITL9D
childrens mapapACETAMINOPHENProficient Rx LP88c4183a-3032-46de-bf18-f700055f617b2023-10-01WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEProficient Rx LPd860af16-fab4-4263-9e66-a648d5e81dab2023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.b9f61b9c-d3f9-47e3-94a3-b5228f96f9272023-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 4ELV7Z65AP
AcetaminophenACETAMINOPHENCVS PHARMACY, INC852e70e2-7279-6f33-e053-2991aa0a86762023-08-28WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN ASPIRIN AND CAFFEINEACETAMINOPHEN, ASPIRIN AND CAFFEINEBetter Living Brands, LLCf8050cae-8619-f49b-e053-6294a90ad9e62023-08-17WarningsExact identifier
unii: 362O9ITL9D
GEWORINACETAMINOPHEN, ISOPROPYLANTIPYRINELydia Co., Ltd.f46826d8-fdef-bfaf-e053-2a95a90aa89e2023-08-09WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENEugia US LLCf80b6f72-f280-4b4a-a6a9-e6490b94705b2023-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP62dd3c7a-4150-44a2-b05b-bc31308f22002023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
good sense migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPed491286-f756-42f7-9a35-ea0380d1ff582023-08-01WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)Wal-Mart Stores Inc.e7b36e3c-0e8a-1aeb-e053-2995a90a51a42023-07-17WarningsExact identifier
unii: 362O9ITL9D
Children Pain ReliefCHILDREN PAIN RELIEFAllegiant Health44c90cbe-8ece-4dd8-9ea5-7f8d6f4c00962023-07-17WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULESLannett Company, Inc.4d62259d-a582-4621-b62e-3d5640cadf7c2023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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