Home NDC 48878-4061 OMNI
Product NDC 48878-4061
11-digit product format 488784061
Labeler code 48878
Product ID 48878-4061_5f88065a-e74d-4285-93d2-b208bf197523
Type HUMAN OTC DRUG
Nonproprietary name Stannous Fluoride
Dosage form GEL
Route ORAL
Labeler Solventum US LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 1998-02-01
Substance STANNOUS FLUORIDE
Active strength .969 mg/g
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 OMNI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE .969 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 48878-4061-3 OMNI 1 in 1 BOX GEL 1 7 48878-4061-3 OMNI 121.9 g in 1 TUBE GEL 121.9 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 48878-4061 OMNI (STANNOUS FLUORIDE) GEL [SOLVENTUM US LLC] 7 Current NDC, Legacy NDC, 2 package rows 20240808_0c2a81b1-65b5-432b-8e66-30432a245aba.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 40 of 50 · 995 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 48878-4061-3 48878406103 1 TUBE in 1 BOX (48878-4061-3) / 121.9 g in 1 TUBE 1 tube 1998-02-01 0000-00-00 No No Current