Anticavity fluoride rinse

Product NDC
76162-838
11-digit product format
761620838
Labeler code
76162
Product ID
76162-838_4ab9cdfd-2e94-8a3c-e063-6394a90ac07a
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
2024-09-06
Substance
SODIUM FLUORIDE
Active strength
.2 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
Anticavity fluoride rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui240698

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-838-38Anticavity fluoride rinse296 mL in 1 BOTTLE, PLASTICMOUTHWASH2963

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-838ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]1Current NDC, 1 package rows20240907_c3f2e952-a8d5-4e9d-a5c6-09e4f2544179.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNc3f2e952-a8d5-4e9d-a5c6-09e4f25441793
240698sodium fluoride 0.5 MG/ML MouthwashSCDc3f2e952-a8d5-4e9d-a5c6-09e4f25441793
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYc3f2e952-a8d5-4e9d-a5c6-09e4f25441793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-838-3876162083838296 mL in 1 BOTTLE, PLASTIC (76162-838-38) 296 ml2024-09-06NoNoHistorical