Pronamel Repair Whitening

Product NDC
56062-514
11-digit product format
560620514
Labeler code
56062
Product ID
56062-514_437fb5ce-7bc7-ad3e-e063-6394a90a6b66
Type
HUMAN OTC DRUG
Nonproprietary name
Pronamel Repair Whitening
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Publix Super Market Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pronamel Repair Whitening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE.15 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1086243

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
56062-514-44Pronamel Repair Whitening96.3 g in 1 TUBEPASTE, DENTIFRICE96.36
56062-514-44Pronamel Repair Whitening1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-514PRONAMEL REPAIR WHITENING PASTE, DENTIFRICE [PUBLIX SUPER MARKET INC]4Current NDC, 2 package rows20250119_16ee2625-3641-205d-e063-6394a90a742f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN16ee2625-3641-205d-e063-6394a90a742f6
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD16ee2625-3641-205d-e063-6394a90a742f6
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY16ee2625-3641-205d-e063-6394a90a742f6
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY16ee2625-3641-205d-e063-6394a90a742f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
56062-514-44560620514441 TUBE in 1 CARTON (56062-514-44) / 96.3 g in 1 TUBE1 tube2024-09-01NoNoCurrent