Home NDC 85162-002-07 AMERFRESH FLUORIDE
Product NDC 85162-002
Requested package NDC 85162-002-07
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 36 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Optimax Professional Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC c1bbdd36-53fb-43a3-ba20-afbeb6359d31 2025-09-18 Warnings Exact identifier application number: M021 Colgate Total Plaque Pro Release Fresh Mint STANNOUS FLUORIDE Colgate-Palmolive Company 9b1671c4-8680-6e2a-9f10-0400840ca5a9 2025-09-12 Warnings Exact identifier application number: M021 Colgate Total Plaque Pro Release Whitening STANNOUS FLUORIDE Colgate-Palmolive Company ddc09ce5-181a-1b50-7094-314bb58a15cf 2025-09-12 Warnings Exact identifier application number: M021 Cavity Protection Fresh Mint Anticavity Mouthwash SODIUM FLUORIDE Oxyfresh Worldwide Inc 3efc66b2-fcf9-4d26-9cdd-1af8225312b4 2025-09-10 Warnings Exact identifier application number: M021 CLOSE UP Freshening with Mouthwash SODIUM FLUORIDE Church & Dwight Co., Inc. e660b0d7-4cc5-4028-bdf5-016b85899728 2025-09-09 Warnings Exact identifier application number: M021 Essentials Healthy Teeth and Gums SODIUM FLUORIDE 0.24% Church & Dwight Co., Inc. 9652c004-6b47-840f-e053-2995a90a6e98 2025-09-09 Warnings Exact identifier application number: M021 Complete Care Whole Mouth Protection SODIUM FLUORIDE Church & Dwight Co., Inc. d00f9d16-de0e-4ffc-e053-2a95a90a2069 2025-09-09 Warnings Exact identifier application number: M021 The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 3de10638-1a39-b747-e063-6294a90a4ca5 2025-09-03 Warnings Exact identifier application number: M021 Optimax Purple Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC 8264e849-a6b3-4953-a85b-da9d4e7f5a70 2025-09-02 Warnings Exact identifier application number: M021 CAREKON ANTI-CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE Hunan Yinhuatang Pharmaceutical Technology Co., Ltd. 3baca3b6-ff48-0579-e063-6394a90abd08 2025-08-29 Warnings Exact identifier application number: M021 Cloveden 100 times higher concentrated CETYLPYRIDINIUM CHLORIDE Acuseplanet Inc 3c0e1862-293f-4d23-e063-6294a90a33e1 2025-08-10 Warnings Exact identifier application number: M021 Ipana Wintergreen Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc. 5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0 2025-07-28 Warnings Exact identifier application number: M021 Ipana Bucky Beaver Bubble Gum Childrens Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc e7aa2a8d-7140-4718-bf69-917bb50d32c7 2025-07-28 Warnings Exact identifier application number: M021 Dubai Chocolate Flavor ANTICAVITY TOOTHPASTE SuperMouth, LLC. d1615a53-ecfc-49d1-b836-f7643b9d2660 2025-07-24 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Mint Burst SODIUM FLUORIDE Chattem, Inc. 0c7ede82-3b28-40ae-8dfd-cec58825f938 2025-07-23 Warnings Exact identifier application number: M021 Dubai Chocolate Fluoride Mouthwash ANTICAVITY MOUTHWASH SuperMouth, LLC. ef81a983-64c1-4913-9235-25451f023852 2025-07-23 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Cool Mint SODIUM FLUORIDE Chattem, Inc. 3409a749-4a1a-4950-8c21-364d1b977af7 2025-07-22 Warnings Exact identifier application number: M021 Act Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8 2025-07-22 Warnings Exact identifier application number: M021 Brush Buddies Oral Rinse Sparkle Mint SODIUM FLUORIDE ASHTEL STUDIOS, INC fe2c06fc-6497-4888-877f-1a88e02fad20 2025-07-15 Warnings Exact identifier application number: M021 evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios, Inc. 1620c7fa-2af6-4462-af5d-9e122942788a 2025-07-15 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 85162-002-07 85162000207 1000 POUCH in 1 BOX (85162-002-07) / 7 g in 1 POUCH 1000 pouch 2025-01-16 No No Current