Pronamel Repair Whitening

Product NDC
11822-6310
11-digit product format
118226310
Labeler code
11822
Product ID
11822-6310_441ef4c5-4903-159d-e063-6394a90aebd0
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Rite Aid
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
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
11822-6310-1Pronamel Repair Whitening96 g in 1 TUBEPASTE, DENTIFRICE963
11822-6310-1Pronamel Repair Whitening1 in 1 CARTONPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-6310PRONAMEL REPAIR WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]2Current NDC, 2 package rows20250124_21645dd5-5cb7-2088-e063-6394a90a61ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN21645dd5-5cb7-2088-e063-6394a90a61ff3
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD21645dd5-5cb7-2088-e063-6394a90a61ff3
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY21645dd5-5cb7-2088-e063-6394a90a61ff3
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY21645dd5-5cb7-2088-e063-6394a90a61ff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11822-6310-1118226310011 TUBE in 1 CARTON (11822-6310-1) / 96 g in 1 TUBE1 tube2024-12-01NoNoHistorical