Home NDC 76357-106 SmartMouth
Product NDC 76357-106
11-digit product format 763570106
Labeler code 76357
Product ID 76357-106_3edc9654-62e0-4c93-8cc7-123cd9edd10c
Type HUMAN OTC DRUG
Nonproprietary name Sodium Monofluorophosphate
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Triumph Pharmaceuticals Inc.
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-06-17
Marketing end 0000-00-00
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength 1 mg/g
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 12 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 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 76357-106-04 ad56d346431e…cc804d4bbf1e…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 76357-106-04 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 76357-106-04 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 76357-106-04 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 76357-106-04 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 76357-106-04 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 76357-106-04 SmartMouth Advance Clinical Formula 170 g in 1 TUBE PASTE, DENTIFRICE 170 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Sodium Monofluorophosphate ACTIVE INGREDIENT C810JCZ56Q SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Fluoride Ion ACTIVE MOIETY Q80VPU408O SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Benzoic Acid INACTIVE INGREDIENT 8SKN0B0MIM SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 D&C Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Hydrated Silica INACTIVE INGREDIENT Y6O7T4G8P9 SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Sodium Lauryl Sulfate INACTIVE INGREDIENT 368GB5141J SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1 Zinc Chloride INACTIVE INGREDIENT 86Q357L16B SMARTMOUTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76357-106 SMARTMOUTH ADVANCE CLINICAL FORMULA (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.] 9 Legacy NDC, 1 package rows 20250101_9caa17c9-f864-4c9c-b2ea-dfaed0c6708e.zip
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 76357-106-04 76357010604 170 g in 1 TUBE (76357-106-04) 170 g 2011-06-17 0000-00-00 No No Current