OraPro Fluoride Anticavity

Product NDC
83610-1060
11-digit product format
836101060
Labeler code
83610
Product ID
83610-1060_3995ff67-0795-cc1d-e063-6394a90af7ff
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride Toothpaste
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Protegera, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-30
Substance
SODIUM FLUORIDE
Active strength
1.4 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OraPro Fluoride Anticavity
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.4 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83610-1060-1OraPro Fluoride Anticavity1 in 1 CARTONPASTE, DENTIFRICE14
83610-1060-1OraPro Fluoride Anticavity147 g in 1 TUBEPASTE, DENTIFRICE1474

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN93b0181c-e29f-42f4-80f5-366463b68f094
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD93b0181c-e29f-42f4-80f5-366463b68f094
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY93b0181c-e29f-42f4-80f5-366463b68f094
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY93b0181c-e29f-42f4-80f5-366463b68f094
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY93b0181c-e29f-42f4-80f5-366463b68f094

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83610-1060-1836101060011 TUBE in 1 CARTON (83610-1060-1) / 147 g in 1 TUBE1 tube2025-06-30NoNoHistorical