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 48 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 LG H&H CO., LTD. 13910b55-9b5d-af53-e063-6294a90acf5d 2024-03-13 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Quebec Inc. DBA Attitude e3bb60f8-2a06-42d6-a182-8c31bb982a2a 2024-03-01 Warnings Exact identifier application number: M021 Maximum Security SODIUM FLUORIDE Bob Barker Company Inc. e29f30ec-72ea-4944-a2c2-b1696d31b639 2024-02-27 Warnings Exact identifier application number: M021 Made by Dentists For Kids Monster Slime Sour Apple SODIUM FLUORIDE MADE BY DENTISTS INC dfddc67c-3626-48c4-8120-bcc6c455d119 2024-02-23 Warnings Exact identifier application number: M021 Orajel Gabbys Dollhouse SODIUM FLUORIDE Church & Dwight Co., Inc. cd47bd1e-44ac-465f-8529-6073ade14706 2024-02-23 Warnings Exact identifier application number: M021 Colgate Kids Maximum Cavity Protection SODIUM FLUORIDE Colgate-Palmolive c44c7a7e-fc3e-a81b-1961-ff89614b678f 2024-02-22 Warnings Exact identifier application number: M021 TheraBreath Fresh Breath Anticavity Mild Mint SODIUM FLUORIDE Church & Dwight Co., Inc. 19ce5324-7d8d-4d70-ad9b-238f7e612eac 2024-02-06 Warnings Exact identifier application number: M021 Nature Mint Anticavity SODIUM MONOFLUOROPHOSPHATE Bob Barker Company Inc. 916891d3-5234-46a8-a492-21a31f36a852 2024-02-02 Warnings Exact identifier application number: M021 Treatment Rinse Mint ANTICARIES DENTAL ALLIANCE HOLDINGS LLC f1255065-b7c3-4eb6-e053-2995a90afcdb 2024-01-31 Warnings Exact identifier application number: M021 Maintenance Rinse Mint ANTICARIES Dental Alliance Holdings LLC f1273510-aa83-3ef9-e053-2a95a90aea27 2024-01-31 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 50G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98d839e3-a1aa-c83d-e053-2995a90a7e79 2024-01-30 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 200G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98aebbec-aec0-1478-e053-2a95a90a03ea 2024-01-30 Warnings Exact identifier application number: M021 Toms Childrens Anticavity Mouthwash Silly Strawberry SODIUM FLUORIDE Tom's of Maine, Inc. 998c6f35-20f4-4cb8-bc48-6aa39e61481a 2024-01-18 Warnings Exact identifier application number: M021 Gel-Kam Fruit and Berry STANNOUS FLUORIDE Colgate Oral Pharmaceuticals, Inc. 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c 2024-01-18 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 9a976ac8-d966-4d94-93da-45652f2d2481 2024-01-12 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 2b4b6f9a-0e31-4891-8721-d1b9a58cca96 2024-01-12 Warnings Exact identifier application number: M021 Colgate MaxFresh with Mini Breath Cool Mint SODIUM FLUORIDE Colgate-Palmolive Company 51abd6bc-7a3d-4b0e-a810-af9e94926438 2024-01-09 Warnings Exact identifier application number: M021 Colgate Enamel Strength Mouthwash SODIUM FLUORIDE Colgate-Palmolive - do not use f0cca38b-c0a3-4788-8cca-727a5684c16b 2024-01-09 Warnings Exact identifier application number: M021 PerCara Oral Health Rinse Fresh Mint CETYLPYRIDINIUM CHLORIDE LEC Custom Products, Inc bd98c654-218b-15ac-e053-2a95a90a75d1 2024-01-01 Warnings Exact identifier application number: M021 PerCara Kids Bubble Gum SODIUM FLUORIDE LEC Custom Products, Inc. be3a7272-acfb-7d14-e053-2995a90a9420 2024-01-01 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