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 16 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Toms of Maine Whiten Plus Deep Clean Peppermint	SODIUM FLUORIDE	Tom's of Maine	4c535776-3f80-4eeb-bb63-2d734c3c3a6b	2026-02-18	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	dd6bf8df-1e28-4f61-b876-b9f1f8d5993a	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	8283cea0-7b62-4796-8763-6654039664cd	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	9d055fed-26d8-4827-a4cc-8c314514a6c3	2026-02-17	Warnings	Exact identifier application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc.	28d1b8c3-930f-4ac9-aa5a-b72b832bb77e	2026-02-17	Warnings	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	088b95e6-30fd-4263-9fdc-57cd63385b71	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	e31c1609-a1c3-4ed5-adfd-3cfa63205ec3	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	3602c528-5f53-4d41-bf67-163149f52b35	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	e696038c-182e-4325-9b90-87fe498d9f67	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	3b04142a-4a65-45ba-a5a2-e62b0c47ec55	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Topco Associates LLC	c640adc0-e178-4b6a-af44-07d2f7da81d3	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	f760f8f8-0c74-4a6e-b5c9-cc82b8758a45	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Topco Associates LLC	ade7dcb2-b4e2-4cef-b9a7-469867ead68a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Topco Associates LLC	84b30711-a7e5-4189-895a-a7989f05591c	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity fluoride rinse	SODIUM FLUORIDE	Topco Associates LLC	c3f2e952-a8d5-4e9d-a5c6-09e4f2544179	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Topco Associates LLC	a9b8b2fe-0a60-4f65-b6f6-aae8509c919f	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Salivea	FLUORIDE TOOTHPASTE	Laclede, Inc.	4abb0f80-d87d-730f-e063-6294a90a15f7	2026-02-13	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Your Military Exchanges	581d5cdb-018a-42ad-899d-5331f0063376	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Your Military Exchanges	965911c3-7aa8-4830-8269-6aa5d526ee73	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Walgreen Co.	eae87899-3eba-4d50-bc31-9eaf54ff9e00	2026-02-12	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