Anticavity Fluoride Rinse

Product NDC
11344-004
11-digit product format
113440004
Labeler code
11344
Product ID
11344-004_4cd5ccc1-55d0-dc79-e063-6394a90aa66f
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Nice-Pak Products, LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-29
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-004-44Anticavity Fluoride Rinse532 mL in 1 BOTTLE, PLASTICMOUTHWASH5324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-004ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CONSUMER PRODUCT PARTNERS, LLC]3Current NDC, 1 package rows20250315_c71d4064-f938-477b-9346-eb38be65390d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNc71d4064-f938-477b-9346-eb38be65390d4
240698sodium fluoride 0.5 MG/ML MouthwashSCDc71d4064-f938-477b-9346-eb38be65390d4
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYc71d4064-f938-477b-9346-eb38be65390d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-004-4411344000444532 mL in 1 BOTTLE, PLASTIC (11344-004-44) 532 ml2024-02-29NoNoCurrent