Home NDC 11527-745 Sodium Fluoride 5000 ppm Enamel Protect
Product NDC 11527-745
11-digit product format 115270745
Labeler code 11527
Product ID 11527-745_3fa71e96-0c84-4ce6-8aa8-6689b876c480
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride1.1%, Potassium Nitrate 5%
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Sheffield Pharmaceuticals LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2021-01-08
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 57.5; 5.8 mg/mL; mg/mL
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 Sodium Fluoride 5000 ppm Enamel Protect
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 57.5 mg/mL SODIUM FLUORIDE 5.8 mg/mL
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11527-745-34 Sodium Fluoride 5000 ppm Enamel Protect 1 in 1 CARTON GEL, DENTIFRICE 1 1 11527-745-34 Sodium Fluoride 5000 ppm Enamel Protect 100 mL in 1 TUBE GEL, DENTIFRICE 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11527-745 SODIUM FLUORIDE 5000 PPM ENAMEL PROTECT (SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%) GEL, DENTIFRICE [SHEFFIELD PHARMACEUTICALS LLC] 1 Current NDC, Legacy NDC, 2 package rows 20210112_83dfdead-4f71-404e-90ae-dbd6849c7cf1.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11527-745-34 11527074534 1 TUBE in 1 CARTON (11527-745-34) / 100 mL in 1 TUBE 1 tube 2021-01-08 0000-00-00 No No Current