Home NDC 55910-820 Rexall Restore and Defend Sensitive Whitening
Product NDC 55910-820
11-digit product format 559100820
Labeler code 55910
Product ID 55910-820_513e53d3-ae6a-4030-8052-e7b7b6ba32b3
Type HUMAN OTC DRUG
Nonproprietary name Stannous Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Old East Main CO.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-03-21
Substance STANNOUS FLUORIDE
Active strength 4.54 mg/g
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 55910-820-01 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 55910-820-01 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 55910-820-01 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 55910-820-01 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 55910-820-01 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 Restore and Defend Sensitive Whitening
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE 4.54 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3FTR44B32Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416784 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55910-820-01 Rexall Restore and Defend Sensitive Whitening 96.4 g in 1 TUBE PASTE, DENTIFRICE 96.4 2 55910-820-01 Rexall Restore and Defend Sensitive 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 55910-820 REXALL RESTORE AND DEFEND SENSITIVE WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [OLD EAST MAIN CO.] 2 Current NDC, Legacy NDC, 2 package rows 20241017_691c9638-75d2-4e53-bec4-2eafacd7216c.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 42 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05a9cee1-bd6e-6b93-e063-6294a90a5c10 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Advanced Whitening Prebiotic Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. f546470a-7fae-4988-e053-2995a90ab61b 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Whitening Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. de97dbea-dc8c-ebfa-e053-2995a90a2270 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Pumpin Strawberry SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05b1020b-a1c3-e1eb-e063-6394a90ac266 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Complete Protection Prebiotic Mint Blast SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. f547a468-d2fd-7176-e053-2995a90a5539 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Whitening Essentials 10X Charcoal Black Clean Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. b4530d56-3a17-6868-e053-2995a90a2524 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Total Care Strong Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. de996aeb-9ac0-836f-e053-2a95a90aeda6 2025-01-01 Warnings Exact identifier application number: M021 POP Hint Of Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05aafc53-49ca-eacd-e063-6394a90a606b 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Whatzzup Watermelon SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05b18bb6-9fbf-469b-e063-6294a90a4f2f 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials 10X Charcoal Black Clean Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 9c820740-9148-3a9c-e053-2a95a90a3968 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Whitening Essentials Fresh Aloe Green Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. a3b21ceb-5aa5-29b4-e053-2a95a90a9545 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Pumpin Strawberry SODIUM FLUORIDE LG H&H Co., Ltd. 05b25897-460c-2dfb-e063-6294a90ada3b 2025-01-01 Warnings Exact identifier application number: M021 EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE LG H&H Co., Ltd. 05b1f105-6f75-7a45-e063-6394a90a58bc 2025-01-01 Warnings Exact identifier application number: M021 POP Hint Of Mint SODIUM FLUORIDE LG H&H Co., Ltd. 05b25083-12f3-7a85-e063-6394a90a492e 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Whatzzup Watermelon SODIUM FLUORIDE LG H&H Co., Ltd. 05b276a1-3778-104d-e063-6294a90a7537 2025-01-01 Warnings Exact identifier application number: M021 kids kare STANNOUS FLUORIDE DEN-MAT HOLDINGS, LLC. 66d7ae1f-ff7a-7fe4-e053-2991aa0a9f91 2024-12-31 Warnings Exact identifier application number: M021 Kids Kare SODIUM FLUORIDE DEN-MAT HOLDINGS, LLC. 66d6b20f-d0ff-4dfe-e053-2991aa0a99ca 2024-12-31 Warnings Exact identifier application number: M021 Morning Fresh SODIUM FLUORIDE Dynarex Corporation 1d0457d7-0228-4ea3-9755-73bacd2201e6 2024-12-27 Warnings Exact identifier application number: M021 Bubble Fresh Toothpaste, with Fluoride BUBBLE FRESH TOOTHPASTE, WITH FLUORIDE Dynarex Corporation 2a2f5ed9-31ec-f6c8-e063-6394a90a44d6 2024-12-26 Warnings Exact identifier application number: M021 Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios, Inc. b3006c29-1f7f-4d9f-ab46-5a36df1a0471 2024-12-25 Warnings Exact identifier application number: M021
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 55910-820-01 55910082001 1 TUBE in 1 BOX (55910-820-01) / 96.4 g in 1 TUBE 1 tube 2022-03-21 0000-00-00 No No Current