AMERFRESH FLUORIDE gel

Product NDC: 85162-001
11-digit product format: 851620001
Labeler code: 85162
Product ID: 85162-001_2bce0b25-f314-443b-e063-6394a90a4102
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 gel
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
86279b4d-82e5-45b5-9ba7-94fe3620b850	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
85162-001-01	AMERFRESH FLUORIDE gel	144 in 1 BOX	PASTE, DENTIFRICE	144	1
85162-001-01	AMERFRESH FLUORIDE gel	17 g in 1 TUBE	PASTE, DENTIFRICE	17	1
85162-001-02	AMERFRESH FLUORIDE gel	24 g in 1 TUBE	PASTE, DENTIFRICE	24	1
85162-001-02	AMERFRESH FLUORIDE gel	144 in 1 BOX	PASTE, DENTIFRICE	144	1
85162-001-03	AMERFRESH FLUORIDE gel	43 g in 1 TUBE	PASTE, DENTIFRICE	43	1
85162-001-03	AMERFRESH FLUORIDE gel	144 in 1 BOX	PASTE, DENTIFRICE	144	1
85162-001-04	AMERFRESH FLUORIDE gel	78 g in 1 TUBE	PASTE, DENTIFRICE	78	1
85162-001-04	AMERFRESH FLUORIDE gel	144 in 1 BOX	PASTE, DENTIFRICE	144	1
85162-001-05	AMERFRESH FLUORIDE gel	144 in 1 BOX	PASTE, DENTIFRICE	144	1
85162-001-05	AMERFRESH FLUORIDE gel	85 g in 1 TUBE	PASTE, DENTIFRICE	85	1
85162-001-06	AMERFRESH FLUORIDE gel	144 in 1 BOX	PASTE, DENTIFRICE	144	1
85162-001-06	AMERFRESH FLUORIDE gel	142 g in 1 TUBE	PASTE, DENTIFRICE	142	1
85162-001-07	AMERFRESH FLUORIDE gel	7 g in 1 POUCH	PASTE, DENTIFRICE	7	1
85162-001-07	AMERFRESH FLUORIDE gel	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
85162-001	AMERFRESH FLUORIDE GEL (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD]	1	Current NDC, 14 package rows	20250117_86279b4d-82e5-45b5-9ba7-94fe3620b850.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 46 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste	SODIUM FLUORIDE	LG H&H Co.,Ltd.	1a01481f-3e02-634e-e063-6394a90ac5fc	2024-05-31	Warnings	Exact identifier application number: M021
Dentalclean Doctor Duck Kids Flouride Mouthwash	SODIUM FLUORIDE 0.02%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	18806738-82fa-1a37-e063-6294a90a3888	2024-05-15	Warnings	Exact identifier application number: M021
Dentalclean Blue Diamond Alcohol Free Mouthwash	SODIUM FLUORIDE 0.05%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	1881658c-e371-5513-e063-6394a90a465f	2024-05-15	Warnings	Exact identifier application number: M021
Dentalclean Dr. Duck Strawberry flouride Mouthwash	SODIUM FLUORIDE 0.02%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	1882c82a-3a32-5656-e063-6394a90ae0ed	2024-05-15	Warnings	Exact identifier application number: M021
Dentalclean Booster Kids	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	186ecaeb-9401-9315-e063-6394a90a8e20	2024-05-14	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA ATTITUDE	fefc1060-e1a4-4686-a8d8-84bf1e613abe	2024-05-14	Warnings	Exact identifier application number: M021
Dentalclean Doctor Duck	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	186f2f12-279f-32df-e063-6394a90ad53d	2024-05-14	Warnings	Exact identifier application number: M021
Dentalclean Regenerator Sensitive Kids	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	17f31b5e-dd3b-78df-e063-6294a90a43ab	2024-05-08	Warnings	Exact identifier application number: M021
Dentalclean Dental Gel Booster Adult Use	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	17f3981f-ab4b-0dcd-e063-6294a90a37d9	2024-05-08	Warnings	Exact identifier application number: M021
Dentalclean Sensitive Plus	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	17e0dc93-97bf-7f05-e063-6294a90a9a8b	2024-05-07	Warnings	Exact identifier application number: M021
Dentalclean Whitening Max	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	17e2364e-2511-3021-e063-6294a90a40e1	2024-05-07	Warnings	Exact identifier application number: M021
DeCure	SODIUM MONOFLUOROPHOSPHATE	Scope medical devices private limited	590c4827-f036-45bd-af30-0a4853ca3447	2024-05-07	Warnings	Exact identifier application number: M021
Gelato Homecare	STANNOUS FLUORIDE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf	2024-04-22	Warnings	Exact identifier application number: M021
Gelato Homecare	STANNOUS FLUORIDE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db	2024-04-19	Warnings	Exact identifier application number: M021
Toothpaste, plus Toothbrush	SODIUM FLUORIDE PASTE, DENTIFRICE AND TOOTHBRUSH	Lil' Drug Store Products, Inc.	15ac00f8-da51-6cea-e063-6294a90aeb81	2024-04-09	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Intensive Whitening Spearmint	SODIUM FLUORIDE	LG H&H Co.,Ltd.	14ea1776-ef7f-27a9-e063-6394a90afd49	2024-03-29	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Intensive Whitening Spearmint	SODIUM FLUORIDE	Tai Guk Pharma. Co., Ltd.	14eb9f74-e5f5-e199-e063-6394a90adbf6	2024-03-29	Warnings	Exact identifier application number: M021
Dentalclean Ultra Refreshing Extreme Ice Dental Gel	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	1496636d-6563-d474-e063-6394a90ab73d	2024-03-26	Warnings	Exact identifier application number: M021
Scope Stay Strong	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	142bffe1-1e8c-8567-e063-6394a90af15a	2024-03-21	Warnings	Exact identifier application number: M021
EUTHYMOL Extraordinary Pink Whitening	SODIUM FLUORIDE	Tai Guk Pharm. Co., Ltd.	13907bf6-9a95-c0b2-e063-6394a90a4042	2024-03-13	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	86279b4d-82e5-45b5-9ba7-94fe3620b850	1
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	86279b4d-82e5-45b5-9ba7-94fe3620b850	1
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	86279b4d-82e5-45b5-9ba7-94fe3620b850	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85162-001-01	85162000101	144 TUBE in 1 BOX (85162-001-01) / 17 g in 1 TUBE	144 tube	2025-01-16	No	No	Current
85162-001-02	85162000102	144 TUBE in 1 BOX (85162-001-02) / 24 g in 1 TUBE	144 tube	2025-01-16	No	No	Current
85162-001-03	85162000103	144 TUBE in 1 BOX (85162-001-03) / 43 g in 1 TUBE	144 tube	2025-01-16	No	No	Current
85162-001-04	85162000104	144 TUBE in 1 BOX (85162-001-04) / 78 g in 1 TUBE	144 tube	2025-01-16	No	No	Current
85162-001-05	85162000105	144 TUBE in 1 BOX (85162-001-05) / 85 g in 1 TUBE	144 tube	2025-01-16	No	No	Current
85162-001-06	85162000106	144 TUBE in 1 BOX (85162-001-06) / 142 g in 1 TUBE	144 tube	2025-01-16	No	No	Current
85162-001-07	85162000107	1000 POUCH in 1 BOX (85162-001-07) / 7 g in 1 POUCH	1000 pouch	2025-01-16	No	No	Current