Home NDC 85162-002 AMERFRESH FLUORIDE
Product NDC 85162-002
11-digit product format 851620002
Labeler code 85162
Product ID 85162-002_2bce0fcd-1d50-cf52-e063-6394a90a3603
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
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 85162-002-01 AMERFRESH FLUORIDE 17 g in 1 TUBE PASTE, DENTIFRICE 17 1 85162-002-01 AMERFRESH FLUORIDE 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-002-02 AMERFRESH FLUORIDE 24 g in 1 TUBE PASTE, DENTIFRICE 24 1 85162-002-02 AMERFRESH FLUORIDE 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-002-03 AMERFRESH FLUORIDE 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-002-03 AMERFRESH FLUORIDE 43 g in 1 TUBE PASTE, DENTIFRICE 43 1 85162-002-04 AMERFRESH FLUORIDE 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-002-04 AMERFRESH FLUORIDE 78 g in 1 TUBE PASTE, DENTIFRICE 78 1 85162-002-05 AMERFRESH FLUORIDE 85 g in 1 TUBE PASTE, DENTIFRICE 85 1 85162-002-05 AMERFRESH FLUORIDE 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-002-06 AMERFRESH FLUORIDE 142 g in 1 TUBE PASTE, DENTIFRICE 142 1 85162-002-06 AMERFRESH FLUORIDE 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-002-07 AMERFRESH FLUORIDE 7 g in 1 POUCH PASTE, DENTIFRICE 7 1 85162-002-07 AMERFRESH FLUORIDE 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 85162-002 AMERFRESH FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD] 1 Current NDC, 14 package rows 20250117_827e45bb-84c0-48ee-a60b-2cc32b8f33e3.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 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Colgate Anticavity Kit SODIUM MONOFLUOROPHOSPHATE Ming Fai Industrial (Shenzhen) Co. Ltd 86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec 2025-12-05 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Nano-Hydroxyapatite SODIUM FLUORIDE Dr Jen Natural, LLC 8b28b857-9162-4065-b0a0-571efffe9787 2025-12-05 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Ortho SODIUM FLUORIDE Dr Jen Natural, LLC 9dd248bf-9488-43cd-a041-e8315a05ce5d 2025-12-04 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Perio SODIUM FLUORIDE Dr Jen Natural, LLC 8c7e6d3a-49d9-4098-9d5e-e9792b373574 2025-12-04 Warnings Exact identifier application number: M021 Colgate Total Plaque Cleanse STANNOUS FLUORIDE Colgate-Palmolive Company b2980238-5bcb-467f-9e90-a307938632c2 2025-12-03 Warnings Exact identifier application number: M021 Advance White Extreme Whitening Tartar Control SODIUM FLUORIDE Church & Dwight Co., Inc. b539264f-e1ff-440b-af76-84266fe2c0a2 2025-12-02 Warnings Exact identifier application number: M021 Sensodyne Pronamel Clinical Enamel Strength Fresh Breath POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC 34a1a32e-3017-f018-e063-6394a90a0230 2025-12-01 Warnings Exact identifier application number: M021 PRO-SYS SODIUM FLUORIDE AND POTASSIUM NITRATE Benco Dental 4e470ba4-60bb-1815-e063-6294a90abacc 2025-12-01 Warnings Exact identifier application number: M021 PRO-SYS SODIUM FLUORIDE Benco Dental 4e539cb2-bcbd-95fc-e063-6294a90a2121 2025-12-01 Warnings Exact identifier application number: M021 Cool sense Care Plus SODIUM FLUORIDE DONG IL PHARMS CO., LTD. 44763bf6-caf3-ec69-e063-6394a90a0ee1 2025-11-25 Warnings Exact identifier application number: M021 DOCTRUST DOUBLEX Tooth SODIUM FLUORIDE DONG IL PHARMS CO.,LTD 44765e86-2eb2-6381-e063-6394a90a761f 2025-11-25 Warnings Exact identifier application number: M021 TheraBreath for Kids Anticavity Wacky Watermelon SODIUM FLUORIDE Church & Dwight Co., Inc. 578f8010-6b1c-4c6b-91d3-e483ace40f66 2025-11-25 Warnings Exact identifier application number: M021 Sensodyne Cavity and Sensitivity POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC d002074b-0580-4247-b3c7-121b8c098697 2025-11-24 Warnings Exact identifier application number: M021 CVS Pharmacy Enamel Guard FLUORIDE CVS Pharmacy 18295a1c-c2a6-489b-be34-9252b9e1e2b8 2025-11-21 Warnings Exact identifier application number: M021 365 Everyday Value Cavity Fighting and Whitening SODIUM MONOFLOUROPHOSPHATE Whole Foods Market, Inc. 83704717-19bc-2634-e053-2991aa0a2979 2025-11-21 Warnings Exact identifier application number: M021 Whitening MONOFLUOROPHOSPHATE Target 0074630f-9d8d-9209-e063-6294a90a4f01 2025-11-21 Warnings Exact identifier application number: M021 Rite Aid Enamel Guard FLUORIDE Rite Aid 67c1fc04-0f21-4944-8b9d-0d8ffd051874 2025-11-21 Warnings Exact identifier application number: M021 ME MOTHER EARTH ZERO WASTE TOOTHPASTE TABLETS PEPPERMINT A PLUS MERCHANDISE LLC 43d30abc-889a-5377-e063-6294a90ab804 2025-11-17 Warnings Exact identifier application number: M021 Natural White Sensitivity and Gum STANNOUS FLUORIDE Lornamead Products 2e83bda8-4d4b-640f-e063-6294a90abc60 2025-11-14 Warnings Exact identifier application number: M021 CVS Pharmacy Restore and Defend FLUORIDE CVS Pharmacy 99f86135-05b7-42b1-aef5-df4513259b8f 2025-11-14 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85162-002-01 85162000201 144 TUBE in 1 BOX (85162-002-01) / 17 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-002-02 85162000202 144 TUBE in 1 BOX (85162-002-02) / 24 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-002-03 85162000203 144 TUBE in 1 BOX (85162-002-03) / 43 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-002-04 85162000204 144 TUBE in 1 BOX (85162-002-04) / 78 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-002-05 85162000205 144 TUBE in 1 BOX (85162-002-05) / 85 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-002-06 85162000206 144 TUBE in 1 BOX (85162-002-06) / 142 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-002-07 85162000207 1000 POUCH in 1 BOX (85162-002-07) / 7 g in 1 POUCH 1000 pouch 2025-01-16 No No Current