Home NDC 85162-001 AMERFRESH FLUORIDE gel
Product NDC 85162-001
11-digit product format 851620001
Labeler code 85162
Product ID 85162-001_2bce0b25-f314-443b-e063-6394a90a4102
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route TOPICAL
Labeler Yangzhou ONE & ONLY Personal Care Products Co., LTD
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-16
Substance SODIUM FLUORIDE
Active strength .1 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 AMERFRESH FLUORIDE gel
Listing expiration 2026-12-31 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 85162-001-01 AMERFRESH FLUORIDE gel 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-001-01 AMERFRESH FLUORIDE gel 17 g in 1 TUBE PASTE, DENTIFRICE 17 1 85162-001-02 AMERFRESH FLUORIDE gel 24 g in 1 TUBE PASTE, DENTIFRICE 24 1 85162-001-02 AMERFRESH FLUORIDE gel 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-001-03 AMERFRESH FLUORIDE gel 43 g in 1 TUBE PASTE, DENTIFRICE 43 1 85162-001-03 AMERFRESH FLUORIDE gel 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-001-04 AMERFRESH FLUORIDE gel 78 g in 1 TUBE PASTE, DENTIFRICE 78 1 85162-001-04 AMERFRESH FLUORIDE gel 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-001-05 AMERFRESH FLUORIDE gel 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-001-05 AMERFRESH FLUORIDE gel 85 g in 1 TUBE PASTE, DENTIFRICE 85 1 85162-001-06 AMERFRESH FLUORIDE gel 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-001-06 AMERFRESH FLUORIDE gel 142 g in 1 TUBE PASTE, DENTIFRICE 142 1 85162-001-07 AMERFRESH FLUORIDE gel 7 g in 1 POUCH PASTE, DENTIFRICE 7 1 85162-001-07 AMERFRESH FLUORIDE gel 1000 in 1 BOX PASTE, DENTIFRICE 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85162-001 AMERFRESH FLUORIDE GEL (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD] 1 Current NDC, 14 package rows 20250117_86279b4d-82e5-45b5-9ba7-94fe3620b850.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 5 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 85162-001-01 85162000101 144 TUBE in 1 BOX (85162-001-01) / 17 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-001-02 85162000102 144 TUBE in 1 BOX (85162-001-02) / 24 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-001-03 85162000103 144 TUBE in 1 BOX (85162-001-03) / 43 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-001-04 85162000104 144 TUBE in 1 BOX (85162-001-04) / 78 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-001-05 85162000105 144 TUBE in 1 BOX (85162-001-05) / 85 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-001-06 85162000106 144 TUBE in 1 BOX (85162-001-06) / 142 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-001-07 85162000107 1000 POUCH in 1 BOX (85162-001-07) / 7 g in 1 POUCH 1000 pouch 2025-01-16 No No Current