Prime Tooth Care Juicy Peach

Product NDC
87053-004
11-digit product format
870530004
Labeler code
87053
Product ID
87053-004_47f5021a-27a5-1f1b-e063-6394a90aaed7
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 Juicy Peach
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87053-004-00Prime Tooth Care Juicy Peach1 in 1 BOXOINTMENT12
87053-004-00Prime Tooth Care Juicy Peach65 g in 1 TUBEOINTMENT652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87053-004-00870530004001 TUBE in 1 BOX (87053-004-00) / 65 g in 1 TUBE1 tube2025-08-31NoNoCurrent