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 15 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Family Dollar Stores, Inc	32ebc633-5338-4d5a-b075-f10b24761248	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	H E B	51ddc81b-1c90-4998-b538-6761ac113437	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Meijer, Inc.	9a0b6301-2443-41f7-adeb-87578a65c26d	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	CVS Pharmacy, Inc.	344c9d00-ad82-46a9-83e9-68197e1a68bb	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M021
TheraBreath Complete Oral Rinse	ANTICAVITY ORAL RINSE	Church & Dwight Co., Inc.	27c33ae1-52c7-baad-e063-6394a90a0611	2026-02-23	Warnings	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Meijer, Inc.	001777fb-196c-499a-94c8-6cdcef0958e9	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Meijer, Inc.	c628d02f-c834-42b3-b38d-6b9cdcdd0961	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Meijer, Inc.	b17f7a5d-272e-446d-803b-46a6d8e5f18f	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Meijer, Inc.	d85ce60c-ebff-461f-827a-10fddb9c2bf3	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
White Glo Charcoal Baking Soda Maximum White Fluoride Anticavity	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	580c4622-6f9c-48ea-b01e-6ffba7273f24	2026-02-19	Warnings	Exact identifier application number: M021
White Glo Coffee and Tea Stain Remover Fluoride Anticavity	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	f044e213-2403-4f42-a41d-72d58fefcfcb	2026-02-19	Warnings	Exact identifier application number: M021
White Glo Mouthwash Protect Fluoride Anticavity	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	4691584f-8c0c-4589-8b40-89b1779a438d	2026-02-19	Warnings	Exact identifier application number: M021
White Glo Professional Choice Fluoride Anticavity	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	ed8d7506-0385-4422-be77-bcc2db79882f	2026-02-19	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Meijer, Inc.	c4dcb1d8-f2af-4363-8fcd-c7d1197d66ea	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Meijer, Inc.	af34f83f-1328-4897-9d04-72ca5a4101bf	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Meijer, Inc.	acff939e-e98c-4d89-a0c4-0254dc74e672	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity fluoride rinse	SODIUM FLUORIDE	Meijer, Inc.	0bb9fb5f-1893-4187-b60b-05319a8fac6a	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M021
Listerine Total Care Intense Anticavity Fluoride Mouthwash	SODIUM FLUORIDE	Kenvue Brands LLC	4b0404af-309f-7c31-e063-6294a90a5aa1	2026-02-18	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Target Corporation	abfc1973-60ab-44e5-8147-33739d8bd7a3	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Target Corporation	3e4119b2-9506-4305-8cff-163f700265d0	2026-02-18	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