FDA.reportPublic FDA data

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 33 of 61 · 1,204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PCXX NEUTRAL RNS GRAPEFLUORIDE TREATMENTRoss Healthcare Inc.9c40dff1-ff82-44b3-98e5-7f9cbfd1dad62025-11-06WarningsExact identifier
unii: 8ZYQ1474W7
PCXX NEUTRAL RMS BUBBLEGUMFLUORIDE TREATMENTRoss Healthcare Inc.37f90a0f-2c67-456b-997e-8a8a4f5f09d32025-11-06WarningsExact identifier
unii: 8ZYQ1474W7
PCXX NEUTRAL RNS PEPPERMINTFLUORIDE TREATMENTRoss Healthcare Inc.8532d4d9-c960-0051-e053-2a91aa0ad1a62025-11-06WarningsExact identifier
unii: 8ZYQ1474W7
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DentisseSODIUM FLUORIDEDentisse, Inc.326b290a-9bd2-468e-e054-00144ff8d46c2025-11-04WarningsExact identifier
unii: 8ZYQ1474W7
Alpha-ProSODIUM FLUORIDE AND HYDROFLUORIC ACIDDental Technologies, Inc.a86ec65f-f6e1-474d-aeff-412a4716a92c2025-11-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Plak Smacker GREAT WHITE SHARKSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCca5b91aa-f69c-4553-a2b6-acf0ca1d920e2025-11-04WarningsExact identifier
unii: 8ZYQ1474W7
Alpha-ProSODIUM FLUORIDE AND HYDROFLUORIC ACIDDental Technologies, Inc.efe3646d-9eb1-4a49-aeb4-c4c2240568512025-11-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent 5000 Booster Plus FruitasticSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.83986c58-25ed-45a4-9d19-36f6ce32d76c2025-11-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Strawberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426c2aca-ca2b-5e34-e063-6294a90ae37c2025-11-02WarningsExact identifier
unii: 8ZYQ1474W7
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
Watermelon Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426e40cb-e30d-0db1-e063-6294a90a762b2025-10-31WarningsExact identifier
unii: 8ZYQ1474W7
Classic Mint Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425a9b71-5a7f-83e6-e063-6394a90ab7032025-10-30WarningsExact identifier
unii: 8ZYQ1474W7
Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425b1a2e-7576-13a7-e063-6394a90aa8652025-10-30WarningsExact identifier
unii: 8ZYQ1474W7
The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426b8efa-e691-a67d-e063-6394a90abf8d2025-10-30WarningsExact identifier
unii: 8ZYQ1474W7
Blue Raspberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD42583b32-525f-925d-e063-6294a90af76f2025-10-29WarningsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PERIOE KAKAO KIDS StrawberrySODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.4239f8c2-a5f5-3fa6-e063-6294a90acb472025-10-28WarningsExact identifier
unii: 8ZYQ1474W7
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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