FDA.reportPublic FDA data

NDC 58354-101-01 - Zantanol Tab.

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
58354-101
Requested NDC
58354-101-01
Package NDCs from labels
58354-101-01, 58354-101-02
Manufacturer
Cho-A Pharm.Co.,Ltd.
Effective date
2017-02-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zantanol Tab. - Cho-A Pharm.Co.,Ltd.Cho-A Pharm.Co.,Ltd.2017-02-28HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58354-101-022020-01-31C16284748780-19d75b9d1-04b3-f424-e053-dadaa90a57ceZantanol Tab.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58354-101-01Zantanol Tab.424 mg in 1 CAPSULETABLET4241
58354-101-02Zantanol Tab.10 in 1 PACKAGETABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58354-101ZANTANOL TAB. (MAGNESIUM OXIDE, MAGNESIUM ALUMINUM HYDRATE) TABLET [CHO-A PHARM.CO.,LTD.]1Legacy NDC, 2 package rows20170301_9b3092fa-86e6-469d-8f73-0626e4c12a28.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 10 of 11 · 220 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Vitrexyl plus IronFERROUS FUMARATE, FOLIC ACIDPureTek Corporationada43056-a3ce-e7de-e053-2a95a90aa0462023-01-11Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
VitrexylFOLIC ACIDPureTek Corporationae064a9e-daba-fa86-e053-2a95a90a16a72023-01-11Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Vitranol FeFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb81daf17-430b-6ba2-e053-2a95a90a768b2023-01-11Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
VitrexateFOLIC ACIDPureTek Corporationb34fee43-bea9-45b7-e053-2a95a90aad4d2023-01-11Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Vitrexate FEFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb3637def-a701-673a-e053-2995a90a02d52023-01-11Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
VenexaFOLIC ACIDPureTek Corporationba130779-cdfd-086d-e053-2a95a90a25902023-01-11Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Venexa FEFERROUS FUMARATE, FOLIC ACIDPureTek Corporationba142128-21c4-4204-e053-2a95a90ae0d72023-01-11Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Ribotin-EFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfcd-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Ventrixyl FeFERROUS FUMARATE, FOLIC ACIDPureTek Corporationc7a626ec-88ec-d899-e053-2a95a90ab0ba2023-01-11Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Zintrexyl-CFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfca-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Magnesia OxydataMAGNESIA OXYDATAHahnemann Laboratories, INC.e45bc2b0-72f4-42e1-e053-2995a90a0e662022-07-21Exact identifier
unii: 3A3U0GI71G
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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