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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1cacf93e-aa60-4717-87ab-0568a701a4f3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 6 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Freshen Up chai latte mint	SODIUM FLUORIDE	MKJ BRANDS LLC	52e364f9-113a-df4e-e063-6294a90a263b	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up Holiday mint	SODIUM FLUORIDE	MKJ BRANDS LLC	5257c409-d379-8c48-e063-6294a90acda9	2026-07-14	Warnings	Exact identifier application number: M021
Freshen-up Matcha Mint	SODIUM FLUORIDE	MKJ BRANDS LLC	52bbc6d9-17ab-851a-e063-6394a90ab4bf	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up pepper mint	SODIUM FLUORIDE	MKJ BRANDS LLC	5259bc45-85da-b17b-e063-6294a90a7919	2026-07-14	Warnings	Exact identifier application number: M021
Colgate Optic White Advanced Icy Fresh	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	f95496e3-11ec-4cd6-b3ee-cf6c657b790b	2026-07-13	Warnings	Exact identifier application number: M021
COLGATE MAX FRESH COCONUT PINEAPPLE	SODIUM FLUORIDE	Colgate-Palmolive Company	7f240d1d-ea3d-42b1-a4b0-106c58707452	2026-07-08	Warnings	Exact identifier application number: M021
Crest 3D White Deep Stain Remover Ultra White	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	2f24a9eb-7a89-30e1-e063-6394a90a032b	2026-07-08		Exact identifier application number: M021
Dr. Noah Kids Tooth	SODIUM MONOFLUOROPHOSPHATE	Project Noah Inc.	562311aa-9ac5-00c2-e063-6394a90a67a7	2026-07-08	Warnings	Exact identifier application number: M021
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	263fef13-347b-489b-987d-933a63dbc900	2026-07-08	Warnings	Exact identifier application number: M021
Colgate Triple Action	SODIUM FLUORIDE	Colgate-Palmolive Company	3082e9ba-66d9-4fc7-bbe6-b41b60939bd2	2026-07-08	Warnings	Exact identifier application number: M021
Colgate Junior Kids Batman Mild Bubble Fruit Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	f464cecb-e876-4057-ab5c-94de747434db	2026-07-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Minty Fresh	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	560815d6-018a-0c24-e063-6394a90a1071	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening with Mouthwash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	54ecfbed-ba99-11eb-e063-6294a90ae64d	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash striped	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	56091601-74dd-0a3b-e063-6394a90af476	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Outlast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	55054217-f21b-1c41-e063-6394a90ae40b	2026-07-07	Warnings	Exact identifier application number: M021
Hello Dragon Dazzle Dragon Dazzle Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	eaca1ad1-9e31-b904-4148-247ad2460661	2026-07-07	Warnings	Exact identifier application number: M021
Colgate Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive Company	cdd2ad04-8c65-40f2-b323-5ce11af52e4f	2026-07-06	Warnings	Exact identifier application number: M021
AIM Cavity Protection with Whitening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	a8c742e1-ee61-4593-b8f5-b9e586d39dfc	2026-07-01	Warnings	Exact identifier application number: M021
TOMS OF MAINE ANTICAVITY FRESHMINT	SODIUM FLUORIDE	Tom's of Maine	6f825520-0f8a-4b4c-bbb6-987f64ab8769	2026-07-01	Warnings	Exact identifier application number: M021
Colgate Deep Clean Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	47e8e943-f4d5-40bc-8f79-ec9ea06125de	2026-07-01	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	1cacf93e-aa60-4717-87ab-0568a701a4f3	2
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	1cacf93e-aa60-4717-87ab-0568a701a4f3	2
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	1cacf93e-aa60-4717-87ab-0568a701a4f3	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
85162-007, Amerfresh Fluoride Toothpowder	Yangzhou ONE & ONLY Personal Care Products Co., LTD	2026-03-10	HUMAN OTC DRUG LABEL	2