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 23 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company973ce138-c64e-c059-e053-2a95a90a31482026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c3ad36-72d8-16e8-e053-2a95a90a87022026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d65b58-9818-820d-e053-2995a90a9f002026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Sensitive and Gum All Day ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d775a1-a4f6-cd69-e053-2995a90a5f642026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Advanced WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4ead762-17b2-22a0-e053-2a95a90ac8662026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Luminous MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c82742-fb27-62a2-e053-2a95a90aa7c42026-01-08WarningsExact identifier
application number: M021
Native WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companya5248d35-f488-3457-e053-2995a90a411e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Companyb7882679-339c-554f-e053-2995a90afa7f2026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Companyb6c180ae-00da-6fab-e053-2a95a90a089e2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6f9a813-7ed6-895c-e053-2995a90a9ea62026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Dual Blast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb788d16a-8a58-0352-e053-2a95a90a965e2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Outlast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb789587e-7f49-163a-e053-2a95a90a823f2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Advanced Whitening Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb81a22dc-b759-24cd-e053-2995a90a91482026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Deep Clean Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb851fe5c-d904-12da-e053-2a95a90a86f92026-01-08WarningsExact identifier
application number: M021
Crest Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyadebbd47-011d-4cd3-a002-1eb67e885e5b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c9b5ef-8dd4-a842-e053-2a95a90ad3872026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7baa77f5-fe45-6566-e053-2991aa0a381f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Vibrant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf63c3354-a264-8130-e053-2a95a90a20222026-01-08Exact identifier
application number: M021
Crest Pro Health Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb466fb4-0915-a41f-e053-6294a90a2dfb2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Clean and FreeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb4771cd-f478-e2bd-e053-6394a90aa83e2026-01-08WarningsExact 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