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 31 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1ba491f4-2ad2-6e7b-e063-6394a90a9fb7	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	188ac743-3ba8-4da4-e063-6294a90a8f87	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b682604-c563-01f1-e063-6294a90ab0bd	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b110db1-fcc0-377f-e063-6394a90a4d44	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1b74ecc4-a1e6-348f-e063-6294a90a5894	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	1b68315c-6afa-3f37-e063-6294a90a14e8	2025-12-11	Warnings	Exact identifier application number: M021
ANTICAVITY FLUORIDE	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	295b88e8-c4b5-c0b0-e063-6394a90aca01	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1b74f072-c33b-c6e2-e063-6394a90ab1e6	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1ba4a807-d6d5-04a0-e063-6294a90ae04d	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b617f4a-b56c-9f75-e063-6294a90a7abe	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	1b9ec370-eadf-92c4-e063-6294a90a9055	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVOR	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1eb04296-ecb1-3ccc-e063-6294a90a9bda	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b9e7b21-0d34-74ec-e063-6294a90a1f59	2025-12-11		Exact identifier application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	28986d7f-3e9a-8dfb-e063-6394a90a731e	2025-12-10	Warnings	Exact identifier application number: M021
Toms of Maine Tropical Island	ALUMINUM CHLOROHYDRATE	Colgate-Palmolive Company	0d6c51bc-5391-4533-b4fd-961dc4f36342	2025-12-10	Warnings	Exact identifier application number: M021
Business Class Kit	SODIUM MONOFLUOROPHOSPHATE	American Airlines, Inc.	483d7aec-34ac-49c5-ac0e-8fba5b4737ae	2025-12-09	Warnings	Exact identifier application number: M021
Colgate Anticavity Kit	SODIUM MONOFLUOROPHOSPHATE	Ming Fai Industrial (Shenzhen) Co. Ltd	121decce-c364-4060-87da-0c6a6cd48474	2025-12-08	Warnings	Exact identifier application number: M021
First Class Kit	SODIUM MONOFLUOROPHOSPHATE	American Airlines, Inc.	ba717de8-c3a2-41bf-85a1-aa75f9744d30	2025-12-08	Warnings	Exact identifier application number: M021
United Airlines Business Class Kit	SODIUM MONOFLUOROPHOSPHATE	United Airlines	94c5e9a4-19f3-4590-9da4-313c75261231	2025-12-08	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Nano-Hydroxyapatite	SODIUM FLUORIDE	Dr Jen Natural, LLC	5f08d994-e458-42b2-aa39-e84fca3acf48	2025-12-05	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