Prime Tooth Care Summer Watermelon

Product NDC
87053-007
11-digit product format
870530007
Labeler code
87053
Product ID
87053-007_47f523e0-e81d-4426-e063-6294a90a344d
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
OINTMENT
Route
DENTAL
Labeler
Prime Tooth Care LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-31
Substance
SODIUM FLUORIDE
Active strength
2.5 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prime Tooth Care Summer Watermelon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87053-007-00Prime Tooth Care Summer Watermelon65 g in 1 TUBEOINTMENT652
87053-007-00Prime Tooth Care Summer Watermelon1 in 1 BOXOINTMENT12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87053-007-00870530007001 TUBE in 1 BOX (87053-007-00) / 65 g in 1 TUBE1 tube2025-08-31NoNoCurrent