Home NDC 11822-6310 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 SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength .15; 5 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pronamel Repair Whitening
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .15 g/100g POTASSIUM NITRATE 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086243 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11822-6310-1 Pronamel Repair Whitening 96 g in 1 TUBE PASTE, DENTIFRICE 96 3 11822-6310-1 Pronamel Repair Whitening 1 in 1 CARTON PASTE, DENTIFRICE 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11822-6310 PRONAMEL REPAIR WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID] 2 Current NDC, 2 package rows 20250124_21645dd5-5cb7-2088-e063-6394a90a61ff.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 9 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 11822-6310-1 11822631001 1 TUBE in 1 CARTON (11822-6310-1) / 96 g in 1 TUBE 1 tube 2024-12-01 No No Current