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 21 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HISMILE SODIUM FLUORIDE HISMILE PTY LTD 1de591d9-9cab-e63d-e063-6394a90ac8eb 2026-01-15 Warnings Exact identifier application number: M021 Ice Pop Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 20e1603e-bcd1-6a5e-e063-6294a90ad1db 2026-01-15 Warnings Exact identifier application number: M021 Hismile CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE HISMILE PTY LTD 1e725b7e-accc-f51c-e063-6394a90a455c 2026-01-15 Warnings Exact identifier application number: M021 Enamelon Preventive Treatment STANNOUS FLUORIDE Premier Dental Products Company 04c3f178-7905-404d-9ac2-67c453287ddf 2026-01-13 Warnings Exact identifier application number: M021 Enamelon STANNOUS FLUORIDE Premier Dental Products Company 1626375a-f78b-4192-b7f3-ca932acab7fb 2026-01-13 Warnings Exact identifier application number: M021 ARU CAVITY PROTECTION SODIUM FLUORIDE Ashtel Studios, Inc. 97bd2934-4bff-4fdb-9199-fcdc0f77fada 2026-01-13 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Cinnamon SODIUM FLUORIDE Chattem, Inc. f2952ca5-c1c3-42fc-82a4-08662286be44 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Wild Watermelon SODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION) Chattem, Inc. bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Pineapple Punch SODIUM FLUORIDE Chattem, Inc. 2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b 2026-01-12 Warnings Exact identifier application number: M021 Botao Kids Strawberry Flavored with Fluoride BOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDE Peer Pharm Ltd. 48b8d884-5e15-4145-8521-ae9ee482e392 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. 4ee6a478-afcf-4540-b427-ba08c942ccb3 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Mint SODIUM FLUORIDE Chattem, Inc. e81c83a2-363a-442f-8731-2598a4f4c21e 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. 258b78b4-55e7-410c-90f8-a3e456c02579 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Dry Mouth Anticavity Mouth SODIUM FLUORIDE Chattem, Inc. 06684b82-aaa0-4ca6-8d56-4f9866269000 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Groovy Grape SODIUM FLUORIDE Chattem, Inc. cd167c0b-2086-4204-b0ac-90df404bd4bb 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. beded786-bb55-4ba3-82fe-9e9d1b5e2979 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Pure Protect Anticavity- Simply Strawberry SODIUM FLUORIDE Chattem, Inc. 2fc80727-57c7-4a33-80e0-ab9f9487390d 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Groovy Grape SODIUM FLUORIDE Chattem, Inc. 310a3c11-1c66-4dac-99f4-5fdc15d0f77c 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Bubblegum SODIUM FLUORIDE Chattem, Inc. fbbccd58-a816-4a93-a658-f28246c11e80 2026-01-12 Warnings Exact identifier application number: M021 ACT Whitening Anticavity Gentle Mint SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION) Chattem, Inc. cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49 2026-01-12 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 85162-001-01 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