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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
827e45bb-84c0-48ee-a60b-2cc32b8f33e3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 14 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anticavity	SODIUM FLUORIDE	Old East Main Co.	64f3d92d-f58c-4bc2-8819-f91492221ddb	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Old East Main Co.	c7b9e9cd-3cf7-4657-83c9-e221e1c35977	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M021
Instant Whitening	INSTANT WHITENING TOOTHPASTE	Guangzhou City Caiye Cosmetics CO., Ltd	2807ece8-a1a5-b626-e063-6394a90aac62	2026-03-02	Warnings	Exact identifier application number: M021
Coffe Tea Stain Remover Tooth	COFFE TEA STAIN REMOVER TOOTHPASTE	Guangzhou City Caiye Cosmetics CO., Ltd	2845d7af-7a0b-9bc8-e063-6294a90ac8b3	2026-03-02	Warnings	Exact identifier application number: M021
Professional whitening tooth	PROFESSIONAL WHITENING TOOTHPASTE	Guangzhou City Caiye Cosmetics CO., Ltd	291eba71-14da-fac3-e063-6294a90aa3cc	2026-03-02	Warnings	Exact identifier application number: M021
purple tooth	PURPLE TOOTHPASTE	Guangzhou City Caiye Cosmetics CO., Ltd	291f0312-238c-71d5-e063-6294a90a39e1	2026-03-02	Warnings	Exact identifier application number: M021
Professional Choice	PROFESSIONAL CHOICE TOOTHPASTE	Guangzhou City Caiye Cosmetics CO., Ltd	28406739-6a8c-1ce8-e063-6394a90a08f8	2026-03-02	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	The Kroger Co.	27a98b64-8369-4f3d-b487-d7ce98abc69f	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	The Kroger Co.	390dd1b5-2dd1-4b55-b4b3-e441ada61238	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	The Kroger Co.	5459eeee-adf0-4afe-b190-62d4fa113806	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	The Kroger Co.	932723b8-9875-4f37-8c11-018c94ae0ae1	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	The Kroger Co.	d0c552d8-44ad-4d95-b3fb-17015f44b334	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Walmart Inc.	3beb65e4-ae8e-4e51-b9ba-181cbec41eff	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Walmart Inc.	61669087-0af6-4192-b514-afcfe7d8ba98	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Walmart Inc.	e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Walmart Inc.	1fd2f3ca-066e-282a-e063-6294a90a05a9	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Walmart Inc.	af5b93e7-5cce-4e01-8df2-54494d8b2910	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Walmart Inc.	4590ca97-130c-46b2-9ba0-38f4703ef30a	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M021
Colgate Anticavity	SODIUM MONOFLUOROPHOSPHATE	MING FAI ENTERPRISE (CAMBODIA) CO., LTD.	4ba81636-cdb7-e904-e063-6394a90a8bd5	2026-02-25	Warnings	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Family Dollar Stores, Inc	32a92add-c9db-4733-8e35-613825fdf081	2026-02-24	Warnings, Adverse reactions	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	827e45bb-84c0-48ee-a60b-2cc32b8f33e3	1
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	827e45bb-84c0-48ee-a60b-2cc32b8f33e3	1
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	827e45bb-84c0-48ee-a60b-2cc32b8f33e3	1

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