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 42 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05a9cee1-bd6e-6b93-e063-6294a90a5c10 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Advanced Whitening Prebiotic Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. f546470a-7fae-4988-e053-2995a90ab61b 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Whitening Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. de97dbea-dc8c-ebfa-e053-2995a90a2270 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Pumpin Strawberry SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05b1020b-a1c3-e1eb-e063-6394a90ac266 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Complete Protection Prebiotic Mint Blast SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. f547a468-d2fd-7176-e053-2995a90a5539 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Whitening Essentials 10X Charcoal Black Clean Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. b4530d56-3a17-6868-e053-2995a90a2524 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Total Care Strong Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. de996aeb-9ac0-836f-e053-2a95a90aeda6 2025-01-01 Warnings Exact identifier application number: M021 POP Hint Of Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05aafc53-49ca-eacd-e063-6394a90a606b 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Whatzzup Watermelon SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 05b18bb6-9fbf-469b-e063-6294a90a4f2f 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials 10X Charcoal Black Clean Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 9c820740-9148-3a9c-e053-2a95a90a3968 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Whitening Essentials Fresh Aloe Green Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. a3b21ceb-5aa5-29b4-e053-2a95a90a9545 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Pumpin Strawberry SODIUM FLUORIDE LG H&H Co., Ltd. 05b25897-460c-2dfb-e063-6294a90ada3b 2025-01-01 Warnings Exact identifier application number: M021 EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE LG H&H Co., Ltd. 05b1f105-6f75-7a45-e063-6394a90a58bc 2025-01-01 Warnings Exact identifier application number: M021 POP Hint Of Mint SODIUM FLUORIDE LG H&H Co., Ltd. 05b25083-12f3-7a85-e063-6394a90a492e 2025-01-01 Warnings Exact identifier application number: M021 POP Gel Whatzzup Watermelon SODIUM FLUORIDE LG H&H Co., Ltd. 05b276a1-3778-104d-e063-6294a90a7537 2025-01-01 Warnings Exact identifier application number: M021 kids kare STANNOUS FLUORIDE DEN-MAT HOLDINGS, LLC. 66d7ae1f-ff7a-7fe4-e053-2991aa0a9f91 2024-12-31 Warnings Exact identifier application number: M021 Kids Kare SODIUM FLUORIDE DEN-MAT HOLDINGS, LLC. 66d6b20f-d0ff-4dfe-e053-2991aa0a99ca 2024-12-31 Warnings Exact identifier application number: M021 Morning Fresh SODIUM FLUORIDE Dynarex Corporation 1d0457d7-0228-4ea3-9755-73bacd2201e6 2024-12-27 Warnings Exact identifier application number: M021 Bubble Fresh Toothpaste, with Fluoride BUBBLE FRESH TOOTHPASTE, WITH FLUORIDE Dynarex Corporation 2a2f5ed9-31ec-f6c8-e063-6394a90a44d6 2024-12-26 Warnings Exact identifier application number: M021 Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios, Inc. b3006c29-1f7f-4d9f-ab46-5a36df1a0471 2024-12-25 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