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 153 of 155 · 3,092 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JEGAMSAN ExtractLONICERA FLOWER, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROMIDEI World Pharmaceutical Co., Ltd.af695c7e-1ad2-ad98-e053-2995a90a2edf2020-09-16WarningsExact identifier
unii: 362O9ITL9D
PEDOXAN ExtractCITRUS UNSHIU PEEL, SAPOSHNIKOVIA ROOT, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af69d604-180c-702f-e053-2a95a90a2ae42020-09-16WarningsExact identifier
unii: 362O9ITL9D
MaekMunDong Tang ExtractJUJUBE, ACETAMINOPHEN, CHLORHENIRAMINE MALEATEI World Pharmaceutical Co., Ltd.af640819-1187-3254-e053-2995a90a29572020-09-15WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENSandoz Inc3b4ab1cf-8642-44f5-b3a2-3f1f7c620ce92020-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital and AcetaminophenBUTALBITAL AND ACETAMINOPHEN TABLETSOceanside Pharmaceuticalsd2213ffd-18f6-45f5-9af7-690a977562c42020-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHEN 500 MGAllegiant Health8e60b78e-ef3c-4d44-b8d4-37cb8608a5c72020-03-13WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.73dea6de-20cb-4cef-b987-3ab2c64e5edb2019-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPdd4dbe5b-8d07-4a96-a78d-2f20da761dad2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP6253b3ae-bb52-4532-8d1f-756c0b1577c72019-11-01Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP0233de1c-466b-4842-8604-6d879aa36a4b2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPdf97ea5a-51df-453b-b1b4-edc74c718ee72019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINELannett Company, Inc.c1107153-494b-4068-8500-96bc241187a52019-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEWestminster Pharmaceuticals, LLC1c0511d0-fe63-45c6-8da2-6ceeb56edb172019-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENAphena Pharma Solutions - Tennessee, LLC89134c3e-ec5b-4a57-952a-98d6c6cff7c22019-02-26WarningsExact identifier
unii: 362O9ITL9D
CounterAct PMACETAMINOPHEN AND DIPHENHYDRAMINEMelaleuca, Inc.7f9a0062-0e86-1deb-e053-2a91aa0a91882019-01-18WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 500mg ESACETAMINOPHEN 500MGAllegiant Health91acc132-01b6-467b-9af5-70f4dc93e0872019-01-08WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 325mg RSACETAMINOPHEN 325MGAllegiant Health61c6d281-e59b-4277-bbce-f71c12c2a56d2019-01-07WarningsExact identifier
unii: 362O9ITL9D
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAllegiant Health9a4c0c43-a71a-4e22-a3d5-9eb9622689a22019-01-02WarningsExact identifier
unii: 362O9ITL9D
Pressure Pain Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association1e54ecb3-c3c3-477a-8725-23f24e77a44b2018-12-31WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PM Extra StrengthACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MGAllegiant Health423a8445-964c-4cdb-889a-f391ca5253e72018-12-31WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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