Anticavity Fluoride Rinse

Product NDC
53942-213
11-digit product format
539420213
Labeler code
53942
Product ID
53942-213_49ef34c3-2ff4-2086-e063-6294a90aa711
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Demoulas Super Markets, Inc
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-25
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 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
53942-213-44Anticavity Fluoride Rinse532 mL in 1 BOTTLE, PLASTICMOUTHWASH5325

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-213ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]4Current NDC, Legacy NDC, 1 package rows20250309_65abfb4d-3a1e-42df-b343-f270ce60a3bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN65abfb4d-3a1e-42df-b343-f270ce60a3bf5
240698sodium fluoride 0.5 MG/ML MouthwashSCD65abfb4d-3a1e-42df-b343-f270ce60a3bf5
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY65abfb4d-3a1e-42df-b343-f270ce60a3bf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-213-4453942021344532 mL in 1 BOTTLE, PLASTIC (53942-213-44) 532 ml2021-08-250000-00-00NoNoCurrent