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 54 of 61 · 1,204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
FLUORIDEXSODIUM FLUORIDEDENT-MAT HOLDINGS, LLC.6050ef4d-50e8-55d7-e053-2991aa0ad0762023-08-03Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Denta 5000 PlusSODIUM FLUORIDERising Pharma Holdings, Inc.7142eb93-54ff-4ba1-af43-3fa3dc1fad012023-07-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Tap Water DetoxACETONE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARSENICUM METALLICUM, BARYTA MURIATICA, CADMIUM METALLICUM, CARBOLICUM ACIDUM, CHLORINUM, CHROMIUM (METALLICUM), CUPRUM METALLICUM, FERRUM METALLICUM, GERMANIUM METALLICUM, NATRUM FLUORATUM, PLUMBUM METALLICUM, RADIUM BROMATUM, VANADIUM METALLICUM, GLYPHOSATE HERBICIDENutritional Specialties, Inc.37a48fea-a8df-4d27-b0c7-e5704c25e72f2023-07-11WarningsExact identifier
unii: 8ZYQ1474W7
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DentaGelSODIUM FLUORIDERising Pharma Holdings, Inc.cda9e1f6-275d-43ba-9e30-f34094e80d952023-05-09Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PreviDent Fresh MintSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.2ecc57ec-cd25-4911-9247-6375569b8abe2023-03-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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