Home NDC 85162-007 Amerfresh Toothpowder
Product NDC 85162-007
11-digit product format 851620007
Labeler code 85162
Product ID 85162-007_4cb875fc-cd0c-7d69-e063-6294a90ab865
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form POWDER
Route TOPICAL
Labeler Yangzhou ONE & ONLY Personal Care Products Co., LTD
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-13
Substance SODIUM FLUORIDE
Active strength .1 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 Toothpowder
Listing expiration 2027-12-31 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 85162-007-01 Amerfresh Toothpowder 454 g in 1 PACKAGE POWDER 454 2 85162-007-01 Amerfresh Toothpowder 40 in 1 CARTON POWDER 40 2 85162-007-02 Amerfresh Toothpowder 50 in 1 BOX POWDER 50 2 85162-007-02 Amerfresh Toothpowder 4 in 1 CARTON POWDER 4 2
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 41 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Quip Anticavity SODIUM FLUORIDE Quip NYC Inc. b6d8a9b6-1fdd-6a54-e053-2995a90a2c1a 2025-01-30 Warnings Exact identifier application number: M021 Quip SODIUM FLUORIDE Quip NYC Inc. 714b7205-444d-929b-e053-2995a90a958e 2025-01-30 Warnings Exact identifier application number: M021 Brush Buddies MY LITTLE PONY ANTICAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios, Inc. 7e8944d3-b8d6-44e6-b38b-f80e4cd28ee4 2025-01-29 Warnings Exact identifier application number: M021 Cool sense Care Plus SODIUM FLUORIDE DOCSMEDI Co., Ltd. ea18ac56-4ef1-4bf0-8c26-6885183fd684 2025-01-22 Warnings Exact identifier application number: M021 DOCTRUST DOUBLEX Tooth SODIUM FLUORIDE DOCSMEDI Co., Ltd. aaf08481-a2ff-48f6-8611-73a469efe1db 2025-01-22 Warnings Exact identifier application number: M021 Double X CONCENTRATED CETYLPYRIDINIUM CHLORIDE DOCSMEDI Co., Ltd. 411be334-364c-4074-8d0b-8dda332f87de 2025-01-22 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Quebec Inc. DBA Attitude d33e3778-ba1d-4560-bafa-74f7ab88c6b5 2025-01-20 Warnings Exact identifier application number: M021 AMERFRESH FLUORIDE gel SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD 86279b4d-82e5-45b5-9ba7-94fe3620b850 2025-01-16 Warnings Exact identifier application number: M021 AMERFRESH FLUORIDE SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD 827e45bb-84c0-48ee-a60b-2cc32b8f33e3 2025-01-16 Warnings Exact identifier application number: M021 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 2025-01-16 Warnings Exact identifier application number: M021 Medpride SODIUM MONOFLUOROPHOSPHATE Shield Line LLC 9c1b0420-6b57-4914-99fe-df6a494815c3 2025-01-16 Warnings Exact identifier application number: M021 Sodium Fluoride SODIUM FLUORIDE Safco Dental Supply LLC 7a295974-c400-4442-9149-138a805ffb20 2025-01-09 Warnings Exact identifier application number: M021 Salivea FLUORIDE TOOTHPASTE Laclede, Inc. 6398ae96-dd38-44da-bc34-1d4d4c4a78ca 2025-01-08 Warnings Exact identifier application number: M021 EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 098a29d5-3836-d362-e063-6394a90a9fea 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Sensitivity Care Prebiotic Clean Mint STANNOUS FLUORIDE Tai Guk Pharm. Co., Ltd. f4ef8ee7-7197-b3dc-e053-2a95a90a1c1b 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Sensitive Clean Mint STANNOUS FLUORIDE Tai Guk Pharm. Co., Ltd. dec29c9f-6ddb-0b4e-e053-2995a90a64b1 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Original Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 8e5de76b-535a-9c95-e053-2995a90afcab 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Blanc Charcoal Fresh Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 8f27c88a-7a70-e00a-e053-2a95a90a95a4 2025-01-01 Warnings Exact identifier application number: M021 POP Feeling Peachy SODIUM FLUORIDE TAI GUK PHARM. CO., LTD 0abb7a95-60b1-a1f3-e063-6294a90ace0c 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Blanc Charcoal Fresh Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 99fff177-6300-220e-e053-2a95a90a0660 2025-01-01 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 85162-007-01 85162000701 40 PACKAGE in 1 CARTON (85162-007-01) / 454 g in 1 PACKAGE 40 package 2025-08-13 No No Current 85162-007-02 85162000702 4 BOX in 1 CARTON (85162-007-02) / 50 POUCH in 1 BOX / 57 g in 1 POUCH 4 box 2025-08-13 No No Current