FDA.reportPublic FDA data

Hoo gargle (apple spearmint flavor)

Product NDC
81840-3333
11-digit product format
818403333
Labeler code
81840
Product ID
81840-3333_eb5dde89-ff6b-4bf2-e053-2995a90a3377
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Flouride
Dosage form
LIQUID
Route
DENTAL
Labeler
MIKO CO LTD
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-09-20
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNe9148945-57e6-2bba-e053-2995a90a8af34
313029sodium fluoride 0.2 MG/ML MouthwashSCDe9148945-57e6-2bba-e053-2995a90a8af34
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYe9148945-57e6-2bba-e053-2995a90a8af34
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYe9148945-57e6-2bba-e053-2995a90a8af34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81840-3333-08184033330010 mL in 1 POUCH10 mlHistorical
81840-3333-18184033330110 in 1 PACKAGEHistorical
81840-3333-28184033330215 in 1 PACKAGEHistorical
81840-3333-38184033330330 in 1 PACKAGEHistorical
81840-3333-48184033330450 in 1 PACKAGEHistorical
81840-3333-581840333305100 PACKAGE in 1 PACKAGE (81840-3333-5) > 50 PACKAGE in 1 PACKAGE (81840-3333-4) > 30 PACKAGE in 1 PACKAGE (81840-3333-3) > 15 PACKAGE in 1 PACKAGE (81840-3333-2) > 10 POUCH in 1 PACKAGE (81840-3333-1) > 10 mL in 1 POUCH (81840-3333-0) 100 package2022-09-200000-00-00NoNoCurrent