NDC 81840-3333-2 - Hoo gargle (apple spearmint flavor)

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
81840-3333
Requested NDC
81840-3333-2
Package NDCs from labels
81840-3333-0, 81840-3333-1, 81840-3333-2, 81840-3333-3, 81840-3333-4, 81840-3333-5
Manufacturer
MIKO CO LTD
Effective date
2023-10-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hoo gargle (apple spearmint flavor) - MIKO CO LTDMIKO CO LTD2023-10-06HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81840-3333-52024-07-30C16284748780-11030e365-508e-111a-e063-dadaa90a10e2Drug Facts
81840-3333-52024-01-30C16284748780-11030e365-508e-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81840-3333-0Hoo gargle (apple spearmint flavor)10 mL in 1 POUCHLIQUID104
81840-3333-1Hoo gargle (apple spearmint flavor)10 in 1 PACKAGELIQUID104
81840-3333-2Hoo gargle (apple spearmint flavor)15 in 1 PACKAGELIQUID154
81840-3333-3Hoo gargle (apple spearmint flavor)30 in 1 PACKAGELIQUID304
81840-3333-4Hoo gargle (apple spearmint flavor)50 in 1 PACKAGELIQUID504
81840-3333-5Hoo gargle (apple spearmint flavor)100 in 1 PACKAGELIQUID1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81840-3333HOO GARGLE (APPLE SPEARMINT FLAVOR) (SODIUM FLOURIDE) LIQUID [MIKO CO LTD]4Legacy NDC, 6 package rows20231007_e9148945-57e6-2bba-e053-2995a90a8af3.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 59 of 60 · 1,181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoriMax 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careae45ae2d-a21f-0a05-e053-2995a90a4d5e2020-09-01WarningsExact identifier
unii: 8ZYQ1474W7
FluoriMax 5000 Sensitive1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTEElevate Oral Careae32b0a2-e42f-6a56-e053-2a95a90a0b002020-08-31WarningsExact identifier
unii: 8ZYQ1474W7
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sodium Fluoride 5000 ppm SensitiveSODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%Sheffield Pharmaceuticals LLC02f4cf0b-188c-4522-b759-ffe4a9d150e82020-04-01Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PreviDent 5000 SensitiveSODIUM FLUORIDE AND POTASSIUM NITRATEColgate Oral Pharmaceuticals, Inc.b028cfff-4946-49e8-b8bb-197ab99d0d352019-12-09Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLC21fa26f2-0162-4044-aec0-d5360be3f3e02019-03-28WarningsExact identifier
unii: 8ZYQ1474W7
FLUORIDEXSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.5fd60635-4b66-15e3-e053-2991aa0ab23a2019-02-28Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Pro-Den RxSODIUM FLUORIDEDen-mat Holdings, Llce39b19f7-2b3e-4c77-9544-623ebad848702019-02-28Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
FLUORIDEXSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.6014c330-3698-027c-e053-2a91aa0a64e52019-02-28Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Pro-Den RxSODIUM FLUORIDEDen-Mat Holdings, Llcba020e07-ad41-4419-a503-f1245131b7d22018-04-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sensitive Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inc.689349e4-3980-a0e4-e053-2991aa0a9ef52018-03-29WarningsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
SF1.1% SODIUM FLUORIDECypress Pharmaceutical, Inc.b7c0a768-7e8a-40b9-876f-b86d3dc5e8482016-07-06Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
SF 5000 Plus1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL CREAMCypress Pharmaceutical, Inc.fa625ece-d873-491a-8d45-2833b64e54252016-07-01Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ionite HSODIUM FLUORIDE, POTASSIUM NITRATEDharma Research, Inc.54c1a27c-5936-4ee2-a419-3891d3df97452015-08-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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