Cavity Protection Fresh Mint Anticavity Mouthwash

Product NDC
63615-001
11-digit product format
636150001
Labeler code
63615
Product ID
63615-001_3e78cdb8-cfb4-903c-e063-6294a90add84
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Oxyfresh Worldwide Inc
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-23
Substance
SODIUM FLUORIDE
Active strength
.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cavity Protection Fresh Mint Anticavity Mouthwash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui240698

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63615-001-01Cavity Protection Fresh Mint Anticavity Mouthwash473 mL in 1 BOTTLE, PLASTICMOUTHWASH4734
63615-001-02Cavity Protection Fresh Mint Anticavity Mouthwash3800 mL in 1 JUGMOUTHWASH38004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63615-001CAVITY PROTECTION FRESH MINT ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) MOUTHWASH [OXYFRESH WORLDWIDE INC]3Current NDC, Legacy NDC, 2 package rows20231026_3efc66b2-fcf9-4d26-9cdd-1af8225312b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN3efc66b2-fcf9-4d26-9cdd-1af8225312b44
240698sodium fluoride 0.5 MG/ML MouthwashSCD3efc66b2-fcf9-4d26-9cdd-1af8225312b44
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY3efc66b2-fcf9-4d26-9cdd-1af8225312b44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63615-001-0163615000101473 mL in 1 BOTTLE, PLASTIC (63615-001-01) 473 ml2014-05-230000-00-00NoNoCurrent
63615-001-02636150001023800 mL in 1 JUG (63615-001-02) 3800 ml2014-05-230000-00-00NoNoCurrent