Mouth Rinse

Product NDC
36800-001
11-digit product format
368000001
Labeler code
36800
Product ID
36800-001_4ab7fbe5-4281-9c7d-e063-6394a90a2392
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Topco Associates LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-12-30
Substance
SODIUM FLUORIDE
Active strength
.1 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mouth Rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui1038904

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-001-86Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100016

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-001MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]15Current NDC, Legacy NDC, 1 package rows20250323_c640adc0-e178-4b6a-af44-07d2f7da81d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038904sodium fluoride 0.0221 % (fluoride ion 0.01 % ) MouthwashPSNc640adc0-e178-4b6a-af44-07d2f7da81d316
1038904sodium fluoride 0.221 MG/ML MouthwashSCDc640adc0-e178-4b6a-af44-07d2f7da81d316
1038904sodium fluoride 0.0221 % (fluoride 0.01 % ) Oral RinseSYc640adc0-e178-4b6a-af44-07d2f7da81d316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-001-86368000001861000 mL in 1 BOTTLE, PLASTIC (36800-001-86) 1000 ml2010-12-300000-00-00NoNoCurrent