Home NDC 42291-741 Sodium Flouride
Product NDC 42291-741
11-digit product format 422910741
Labeler code 42291
Product ID 42291-741_4874ee42-bfbe-02d5-e063-6394a90a2b6e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler AvKARE
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2019-09-20
Substance SODIUM FLUORIDE
Active strength 5 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Flouride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 42291-741-51 Sodium Flouride 53.2 mL in 1 TUBE PASTE, DENTIFRICE 53.2 8 42291-741-51 Sodium Flouride 1 in 1 CARTON PASTE, DENTIFRICE 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-741 SODIUM FLOURIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [AVKARE] 7 Current NDC, Legacy NDC, 2 package rows 20240111_92fef2e0-f9f2-8b0f-e053-2995a90a096a.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 42291-741-51 42291074151 1 TUBE in 1 CARTON (42291-741-51) / 53.2 mL in 1 TUBE 1 tube 2019-09-20 0000-00-00 No No Current