FDA.reportPublic FDA data

CURODONT REPAIR FLUORIDE PLUS

Product NDC
72247-108
11-digit product format
722470108
Labeler code
72247
Product ID
72247-108_3840f669-e285-5f88-e063-6394a90af026
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
SPONGE
Route
ORAL
Labeler
CREDENTIS AG
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-31
Substance
SODIUM FLUORIDE
Active strength
.02 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CURODONT REPAIR FLUORIDE PLUS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.02 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72247-108-01CURODONT REPAIR FLUORIDE PLUS0.25 mL in 1 DOSE PACKSPONGE0.252
72247-108-02CURODONT REPAIR FLUORIDE PLUS5 in 1 POUCHSPONGE52
72247-108-03CURODONT REPAIR FLUORIDE PLUS2 in 1 BOXSPONGE22
72247-108-04CURODONT REPAIR FLUORIDE PLUS4 in 1 BOXSPONGE42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72247-108CURODONT REPAIR FLUORIDE PLUS (SODIUM FLUORIDE) SPONGE [CREDENTIS AG]1Current NDC, 4 package rows20250101_290c57b0-a562-0a51-e063-6294a90a0720.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72247-108-01722470108010.25 mL in 1 DOSE PACK0.25 mlHistorical
72247-108-02722470108025 in 1 POUCHHistorical
72247-108-03722470108032 POUCH in 1 BOX (72247-108-03) / 5 DOSE PACK in 1 POUCH (72247-108-02) / .25 mL in 1 DOSE PACK (72247-108-01) 2 pouch2024-12-31NoNoCurrent
72247-108-04722470108044 POUCH in 1 BOX (72247-108-04) / 5 DOSE PACK in 1 POUCH (72247-108-02) / .25 mL in 1 DOSE PACK (72247-108-01) 4 pouch2024-12-31NoNoCurrent