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 30 of 61 · 1,204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
unii: 8ZYQ1474W7
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
unii: 8ZYQ1474W7
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
unii: 8ZYQ1474W7
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
unii: 8ZYQ1474W7
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
unii: 8ZYQ1474W7
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
unii: 8ZYQ1474W7
PRO-SYSPROFESSIONAL SENSITIVITY, SLS FREE - MINT (5000 PPM)Benco Dental4e4761d7-f1ab-aae4-e063-6294a90a214c2025-12-01WarningsExact identifier
unii: 8ZYQ1474W7
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
unii: 8ZYQ1474W7
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
unii: 8ZYQ1474W7
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDONG IL PHARMS CO.,LTD4476923a-48f1-9f72-e063-6394a90a07082025-11-25WarningsExact identifier
unii: 8ZYQ1474W7
TheraBreath for Kids Anticavity Wacky WatermelonSODIUM FLUORIDEChurch & Dwight Co., Inc.578f8010-6b1c-4c6b-91d3-e483ace40f662025-11-25WarningsExact identifier
unii: 8ZYQ1474W7
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Sensodyne Cavity and SensitivityPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCd002074b-0580-4247-b3c7-121b8c0986972025-11-24WarningsExact identifier
unii: 8ZYQ1474W7
HEB Extra WhiteningFLUORIDEHEB9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0e2025-11-21WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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