Home NDC 61596-400 MIPaste One
Product NDC 61596-400
11-digit product format 615960400
Labeler code 61596
Product ID 61596-400_4651d664-464b-05c1-e063-6394a90a565e
Type HUMAN OTC DRUG
Nonproprietary name MIPaste One
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler GC America Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-03
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 5; .24 g/100g; g/100g
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 MIPaste One
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 5 g/100g SODIUM FLUORIDE .24 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup 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 1038929 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 61596-400-10 MIPaste One 10 in 1 BOX PASTE, DENTIFRICE 10 3 61596-400-40 MIPaste One 46 g in 1 TUBE PASTE, DENTIFRICE 46 3 61596-400-41 MIPaste One 1 in 1 BOX PASTE, DENTIFRICE 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61596-400 MIPASTE ONE PASTE, DENTIFRICE [GC AMERICA INC.] 2 Current NDC, Legacy NDC, 3 package rows 20240128_d71f8e6e-7005-4b3e-e053-2995a90a6789.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 30 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 61596-400-10 61596040010 10 BOX in 1 BOX (61596-400-10) / 1 TUBE in 1 BOX (61596-400-41) / 46 g in 1 TUBE (61596-400-40) 10 box 2022-02-03 0000-00-00 No No Current 61596-400-40 61596040040 46 g in 1 TUBE 46 g Historical 61596-400-41 61596040041 1 in 1 BOX Historical