Home NDC 55910-817 Rexall Sensitive Extra Whitening
Product NDC 55910-817
11-digit product format 559100817
Labeler code 55910
Product ID 55910-817_5cc9ebfc-5de6-4052-90a7-6a0ff0aebbf2
Type HUMAN OTC DRUG
Nonproprietary name Potassium Nitrate, Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Old East Main CO.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-03-21
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 5; .24 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55910-817-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55910-817-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 55910-817-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 55910-817-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 55910-817-01 1332a3947898…d4bfe170f9cd…
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 Rexall Sensitive Extra Whitening
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 5 g/100g SODIUM FLUORIDE .24 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038929 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55910-817-01 Rexall Sensitive Extra Whitening 113 g in 1 TUBE PASTE, DENTIFRICE 113 2 55910-817-01 Rexall Sensitive Extra Whitening 1 in 1 BOX PASTE, DENTIFRICE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-817 REXALL SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [OLD EAST MAIN CO.] 2 Current NDC, Legacy NDC, 2 package rows 20241017_2daf18a3-f71e-4585-8128-4663eff7eb6d.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 Marketing end Sample Exclude flag Status 55910-817-01 55910081701 1 TUBE in 1 BOX (55910-817-01) / 113 g in 1 TUBE 1 tube 2022-03-21 0000-00-00 No No Current