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 7 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT	SODIUM FLUORIDE	Colgate-Palmolive Company	9aaa451d-8827-41b7-9661-bc1a7a69cfc3	2026-06-30	Warnings	Exact identifier application number: M021
CrestPlus Deep Clean plus Whitening Effervescent Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5579be77-97df-1000-e063-6294a90a4725	2026-06-30	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTH	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	358842de-3e1d-4f66-8d08-fe8538441b34	2026-06-29	Warnings	Exact identifier application number: M021
Anticavity mouth rinse Low-foaming Spearmint	718 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINT	Dyson Technology Limited	5356d0a8-2db4-ce7f-e063-6394a90aa6d2	2026-06-26	Warnings	Exact identifier application number: M021
Colgate Optic White Renewal Brilliant Shine	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	70734d67-fc3e-4515-b6e6-ab2c466578d6	2026-06-26	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	f87d6f04-507a-47ae-8a66-204cf59261c0	2026-06-26	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Outlast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5513ba92-cadc-2cf3-e063-6294a90ac3e5	2026-06-25	Warnings	Exact identifier application number: M021
Crest Plus Active Fresh Scope plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5513e40f-b8e8-2d9a-e063-6394a90ab170	2026-06-25	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser Mint Splash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6c690e-a1bb-4606-e063-6394a90ac4b6	2026-06-25		Exact identifier application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Polishing Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f1bbc3d-a1f9-b278-e063-6294a90a62f7	2026-06-25		Exact identifier application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f1bd56c-dac8-eb87-e063-6294a90a3cc1	2026-06-25		Exact identifier application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f0b1d46-d52c-f409-e063-6394a90a5574	2026-06-25		Exact identifier application number: M021
Crest Plus Extra Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5514e09e-0a7d-93e6-e063-6294a90ae3f0	2026-06-25	Warnings	Exact identifier application number: M021
Colgate Sparkling White Mint Zing	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	0c2fe62b-4905-4213-a85b-e073d8eeb741	2026-06-24	Warnings	Exact identifier application number: M021
Colgate MaxFresh Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	890c4c29-bba8-4775-a053-10c6292df930	2026-06-24	Warnings	Exact identifier application number: M021
Crest Premium Plus Active Foam Whitening scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	55004d9d-eda7-a285-e063-6294a90ad4ca	2026-06-24	Warnings	Exact identifier application number: M021
Euthymol Whitening Purple Corrector	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	5500686c-d417-c50a-e063-6294a90ac7fa	2026-06-24	Warnings	Exact identifier application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Dualblast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5500f9ab-b0c4-51d6-e063-6394a90acd38	2026-06-24	Warnings	Exact identifier application number: M021
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5504ec96-aae1-f5f9-e063-6294a90ad8bb	2026-06-24	Warnings	Exact identifier application number: M021
COLGATE SPARKLING WHITE CINNAMINT	SODIUM FLUORIDE	Colgate-Palmolive Company	f2ff18d2-4ef0-454e-a6f1-6f3bf361c7d1	2026-06-24	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