Home NDC 69510-010 Ipana Wintergreen Fluoride
Product NDC 69510-010
11-digit product format 695100010
Labeler code 69510
Product ID 69510-010_3b02acf1-478c-5a1f-e063-6294a90a9a1c
Type HUMAN OTC DRUG
Nonproprietary name SODIUM MONOFLUOROPHOSPHATE
Dosage form PASTE
Route DENTAL
Labeler Maxill Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-31
Marketing end 2029-07-31
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength .1 g/100g
NDC exclude flag No
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 Ipana Wintergreen Fluoride Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE .1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 Internal RxNorm 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 69510-010-19 Ipana Wintergreen Fluoride 1 in 1 BOX PASTE 1 9 69510-010-19 Ipana Wintergreen Fluoride 19 g in 1 TUBE PASTE 19 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69510-010 IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241018_5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0.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 33 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 69510-010-19 69510001019 1 TUBE in 1 BOX (69510-010-19) / 19 g in 1 TUBE 1 tube 2015-01-05 2029-07-31 No No Current