FDA.reportPublic FDA data

NDC 82399-010-01 - BOTA C Reset

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
82399-010
Requested NDC
82399-010-01
Package NDCs from labels
82399-010-01, 82399-010-02
Manufacturer
JB.MONSTER PTY LTD | D & H INTERNATIONAL PTY LTD
Effective date
2021-11-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BOTA C Reset - JB.MONSTER PTY LTD | D & H INTERNATIONAL PTY LTDJB.MONSTER PTY LTD | D & H INTERNATIONAL PTY LTD2021-11-26HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82399-010-022023-01-30C16284748780-1f386c649-b9aa-0266-e053-dadaa90a7c1aa59f6cda-5156-4455-af29-f7c100629a13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82399-010-01BOTA C Reset50 mL in 1 CONTAINERCREAM501
82399-010-02BOTA C Reset1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82399-010BOTA C RESET (NIACINAMIDE, ADENOSINE) CREAM [JB.MONSTER PTY LTD]1Legacy NDC, 2 package rows20211127_a59f6cda-5156-4455-af29-f7c100629a13.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 7 of 21 · 415 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADENOSINEADENOSINE INJECTION, SOLUTIONHenry Schein, Inc.d28ff4f3-baf4-4640-ae00-f0eb065417be2025-10-27Warnings, Adverse reactionsExact identifier
unii: K72T3FS567
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi-Vitamin Drops with Fluoride and IronVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FERROUS SULFATE AND SODIUM FLUORIDEMethod Pharmaceuticals, LLCd5609742-e456-4409-bca9-706b0ea90d352025-10-21Warnings, Adverse reactionsExact identifier
unii: 25X51I8RD4
Multi-Vitamin with FluorideVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, CYANOCOBALAMIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE AND SODIUM FLUORIDEMethod Pharmaceuticals, LLC880df628-5bba-4dc4-b557-1fcc822adba82025-10-21Warnings, Adverse reactionsExact identifier
unii: 25X51I8RD4
Multi-Vitamin with FluorideVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, CYANOCOBALAMIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE AND SODIUM FLUORIDEMethod Pharmaceuticals, LLCfe1e8e8a-0902-4598-bb06-fe5163c1cffb2025-10-21Warnings, Adverse reactionsExact identifier
unii: 25X51I8RD4
LumavexMULTIVITAMINOncora Pharma, LLC4139742d-d091-121c-e063-6394a90a62212025-10-15Warnings, Adverse reactionsExact identifier
unii: 25X51I8RD4
Mitochondria PROARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: 25X51I8RD4
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
unii: 3XUS85K0RA
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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