Home NDC 72164-005 Wintergreen Peppermint
Product NDC 72164-005
11-digit product format 721640005
Labeler code 72164
Product ID 72164-005_48c69282-189f-8bf2-e063-6394a90acf2a
Type HUMAN OTC DRUG
Nonproprietary name POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Twice Twice LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-03-01
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50; 1.5 mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 Wintergreen Peppermint
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g SODIUM FLUORIDE 1.5 mg/g
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 72164-005-00 Wintergreen Peppermint 96 g in 1 TUBE PASTE, DENTIFRICE 96 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72164-005 WINTERGREEN PEPPERMINT (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [TWICE TWICE LLC] 4 Current NDC, Legacy NDC, 1 package rows 20250221_7b7beec2-e070-4102-a2a4-68c332fc9fb3.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 32 of 40 · 786 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 72164-005-00 72164000500 96 g in 1 TUBE (72164-005-00) 96 g 2022-03-01 0000-00-00 No No Current