FDA.reportPublic FDA data

NDC 81840-1003-2 - Hoo gargle (Rooibos Tea Flavor)(Mouthwash)

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
81840-1003
Requested NDC
81840-1003-2
Package NDCs from labels
81840-1003-1, 81840-1003-2, 81840-1003-3, 81840-1003-4
Manufacturer
MIKO CO LTD
Effective date
2022-06-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hoo gargle (Rooibos Tea Flavor)(Mouthwash) - MIKO CO LTDMIKO CO LTD2022-06-24HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81840-1003-42024-07-30C16284748780-11030e365-4a9e-111a-e063-dadaa90a10e2Drug Facts
81840-1003-42024-01-30C16284748780-11030e365-4a9e-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81840-1003-1Hoo gargle (Rooibos Tea Flavor)(Mouthwash)12 mL in 1 CUPLIQUID121
81840-1003-2Hoo gargle (Rooibos Tea Flavor)(Mouthwash)30 in 1 PACKAGELIQUID301
81840-1003-3Hoo gargle (Rooibos Tea Flavor)(Mouthwash)64 in 1 PACKAGELIQUID641
81840-1003-4Hoo gargle (Rooibos Tea Flavor)(Mouthwash)8 in 1 PACKAGELIQUID81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81840-1003HOO GARGLE (ROOIBOS TEA FLAVOR)(MOUTHWASH) (XYLITOL) LIQUID [MIKO CO LTD]1Legacy NDC, 4 package rows20220626_e22c3849-0969-55a8-e053-2a95a90afb1a.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 4 of 9 · 175 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
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
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Kids Oral Care Flavor FreeXYLITOL, CALCIUM LACTATETOOTHFILM INC.33469d77-4013-413d-e063-6294a90acbb72025-04-21WarningsExact identifier
unii: VCQ006KQ1E
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Kids Oral Care Peach FlavorXYLITOL, CALCIUM LACTATETOOTHFILM INC.308614fe-86ee-505e-e063-6394a90a007c2025-03-13WarningsExact identifier
unii: VCQ006KQ1E
Kids Oral Care Vanilla FlavorXYLITOL, CALCIUM LACTATETOOTHFILM INC.308681e3-7b84-7c0e-e063-6394a90a42392025-03-13WarningsExact identifier
unii: VCQ006KQ1E
Kids Oral Care Grape FlavorXYLITOL, CALCIUM LACTATETOOTHFILM INC.30869616-3c3d-8931-e063-6394a90aac522025-03-13WarningsExact identifier
unii: VCQ006KQ1E

Reported adverse events (FAERS/openFDA)#

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