Home NDC 61578-313 Maintenance Rinse
Product NDC 61578-313
11-digit product format 615780313
Labeler code 61578
Product ID 61578-313_1046e99b-bf50-ae6f-e063-6294a90a11f6
Type HUMAN OTC DRUG
Nonproprietary name Anticaries
Dosage form RINSE
Route DENTAL
Labeler Dental Alliance Holdings LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-10
Substance SODIUM FLUORIDE
Active strength 226 ug/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 Maintenance Rinse
Brand name suffix Grape
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 226 ug/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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240698 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 61578-313-01 Maintenance RinseGrape 473 mL in 1 BOTTLE, PLASTIC RINSE 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61578-313 MAINTENANCE RINSE GRAPE (ANTICARIES) RINSE MAINTENANCE RINSE MINT (ANTICARIES) RINSE MAINTENANCE RINSE CITRUS (ANTICARIES) RINSE [DENTAL ALLIANCE HOLDINGS LLC] 2 Current NDC, Legacy NDC, 1 package rows 20240202_f1273510-aa83-3ef9-e053-2a95a90aea27.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 39 of 49 · 974 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 61578-313-01 61578031301 473 mL in 1 BOTTLE, PLASTIC (61578-313-01) 473 ml 2022-05-10 0000-00-00 No No Current