Home NDC 61578-217 Gel 1100
Product NDC 61578-217
11-digit product format 615780217
Labeler code 61578
Product ID 61578-217_8c79367f-d60d-484b-8e32-87de7cf75358
Type HUMAN OTC DRUG
Nonproprietary name sodium fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Dental Alliance Holdings LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-10
Substance SODIUM FLUORIDE
Active strength 1100 ug/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 Gel 1100
Brand name suffix Grape
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1100 ug/g
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416783 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 61578-217-01 Gel 1100Grape 68 g in 1 TUBE, WITH APPLICATOR GEL, DENTIFRICE 68 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61578-217 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [DENTAL ALLIANCE HOLDINGS LLC] 2 Current NDC, Legacy NDC, 1 package rows 20240202_f125fb04-5045-5367-e053-2a95a90aa73b.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 6 of 50 · 995 matching rows.
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 61578-217-01 61578021701 68 g in 1 TUBE, WITH APPLICATOR (61578-217-01) 68 g 2022-05-10 0000-00-00 No No Current