Home NDC 85162-007 Amerfresh Toothpowder
Product NDC 85162-007
11-digit product format 851620007
Labeler code 85162
Product ID 85162-007_4cb875fc-cd0c-7d69-e063-6294a90ab865
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form POWDER
Route TOPICAL
Labeler Yangzhou ONE & ONLY Personal Care Products Co., LTD
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-13
Substance SODIUM FLUORIDE
Active strength .1 g/100g
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 Amerfresh Toothpowder
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .1 g/100g
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 245598 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 85162-007-01 Amerfresh Toothpowder 454 g in 1 PACKAGE POWDER 454 2 85162-007-01 Amerfresh Toothpowder 40 in 1 CARTON POWDER 40 2 85162-007-02 Amerfresh Toothpowder 50 in 1 BOX POWDER 50 2 85162-007-02 Amerfresh Toothpowder 4 in 1 CARTON POWDER 4 2
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 22 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 Sample Exclude flag Status 85162-007-01 85162000701 40 PACKAGE in 1 CARTON (85162-007-01) / 454 g in 1 PACKAGE 40 package 2025-08-13 No No Current 85162-007-02 85162000702 4 BOX in 1 CARTON (85162-007-02) / 50 POUCH in 1 BOX / 57 g in 1 POUCH 4 box 2025-08-13 No No Current