FDA.reportPublic FDA data

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
IngredientStrength
SODIUM FLUORIDE.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
245598Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
827e45bb-84c0-48ee-a60b-2cc32b8f33e3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85162-002-01AMERFRESH FLUORIDE17 g in 1 TUBEPASTE, DENTIFRICE171
85162-002-01AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-02AMERFRESH FLUORIDE24 g in 1 TUBEPASTE, DENTIFRICE241
85162-002-02AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-03AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-03AMERFRESH FLUORIDE43 g in 1 TUBEPASTE, DENTIFRICE431
85162-002-04AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-04AMERFRESH FLUORIDE78 g in 1 TUBEPASTE, DENTIFRICE781
85162-002-05AMERFRESH FLUORIDE85 g in 1 TUBEPASTE, DENTIFRICE851
85162-002-05AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-06AMERFRESH FLUORIDE142 g in 1 TUBEPASTE, DENTIFRICE1421
85162-002-06AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-07AMERFRESH FLUORIDE7 g in 1 POUCHPASTE, DENTIFRICE71
85162-002-07AMERFRESH FLUORIDE1000 in 1 BOXPASTE, DENTIFRICE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85162-002AMERFRESH FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD]1Current NDC, 14 package rows20250117_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 17 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Complete plus Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960e0e3e-10e8-7426-e053-2a95a90a5b022026-02-12WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e2026-02-12WarningsExact identifier
application number: M021
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company126c6f39-0ef7-40ee-b3ba-e56a76739c572026-02-12WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.b2f7490c-e2af-49df-b054-70fb4815f7292026-02-11Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb7d7c41e-f8b6-4e55-8acd-78eb6dda47c52026-02-09WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED48ef2635-7157-4cd7-9f99-967f0143f7f12026-02-09WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INC287887df-64de-4b5d-80e2-146c77c0fa8b2026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES White Care AO ProSODIUM FLUORIDEPERIOSCIENCES LLC092bdfa3-6267-439e-9320-e51b4805d1a12026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES HYDRATING AO ProSODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLC5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d32026-02-09WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERetail Business Services, LLC77c066cf-f064-45d3-9732-4433165ba9ef2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDERetail Business Services, LLCd1c878a9-2151-4986-be09-cbab658cdd312026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDERetail Business Services, LLC542e067a-c134-44c9-b962-f2a2b667b76f2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Colgate 5g Toothbrush KitSODIUM MONOFLUOROPHOSPHATEWuhan Jinshengyuan Textiles Manufacturing Co., Ltd.4f0fda5e-ef42-42c3-8270-3ba614650ad12026-02-06WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERetail Business Services, LLC3954edfd-f7f1-4218-9ee2-23f5b3661b4e2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
TheraBreath Kids Anticavity Oral Rinse BubblegumANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.2770424d-7416-66d4-e063-6394a90ad4b12026-02-06WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity Whitening Plus ScopeSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company463b7820-a5ce-f8b5-e063-6394a90aa0182026-02-05WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.14494238-872b-49e2-8bf7-df3844a0a6c82026-02-05Warnings, Adverse reactionsExact identifier
application number: M021
HAPEE EXPLOSIVE MENTHOL RED 150SODIUM MONOFLUOROPHOSPHATELAMOIYAN CORPORATION14c14694-6149-40a8-aff2-660d39f7e0c12026-02-05WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEHARRIS TEETERf759e9e4-6de2-4b80-903b-e67c06e362952026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEHARRIS TEETER571f7628-fd59-462f-96dd-67aeaa98cff12026-02-04Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN827e45bb-84c0-48ee-a60b-2cc32b8f33e31
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD827e45bb-84c0-48ee-a60b-2cc32b8f33e31
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY827e45bb-84c0-48ee-a60b-2cc32b8f33e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85162-002-0185162000201144 TUBE in 1 BOX (85162-002-01) / 17 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-0285162000202144 TUBE in 1 BOX (85162-002-02) / 24 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-0385162000203144 TUBE in 1 BOX (85162-002-03) / 43 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-0485162000204144 TUBE in 1 BOX (85162-002-04) / 78 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-0585162000205144 TUBE in 1 BOX (85162-002-05) / 85 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-0685162000206144 TUBE in 1 BOX (85162-002-06) / 142 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-002-07851620002071000 POUCH in 1 BOX (85162-002-07) / 7 g in 1 POUCH1000 pouch2025-01-16NoNoCurrent