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 25 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Advanced Enamel RestoreSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd813f5f0-3135-4a8f-e053-2a95a90a55622026-01-08WarningsExact identifier
application number: M021
Crest 3D White BrillianceSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8e189fbd-5094-4398-b96c-8f95d89b9cdd2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Densify RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd84fb9f9-f2bc-358a-e053-2995a90abf072026-01-08WarningsExact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyeb7a5698-754c-4e46-e053-2a95a90a57b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Daily Cleansing and Whitening SystemSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company89a6fb36-5109-47f1-95ad-9381471ceeef2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced w/Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2c1c5563-0b7e-4c7c-b49f-3d72e078cd282026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Fresh MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc81ba39d-c7ea-b2a5-e053-2995a90a0fe72026-01-08Exact identifier
application number: M021
Crest Premium Plus Breath Bacteria BlastSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc3f1d477-6dd8-0ac4-e053-2a95a90a37422026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc72b15e0-e69c-65fc-e053-2a95a90a54c82026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope Outlast UltraSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f63455-b09e-9877-e053-2a95a90a18442026-01-08WarningsExact identifier
application number: M021
Crest Tartar Protection Fresh Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d81d605-4f9b-3bb5-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Complete plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companye3b1f139-4fe8-f005-e053-2995a90a53b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3dd7a34-a0d8-4ac6-bbd1-7c3b86187a572026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Active Fresh plus Whitening ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc599d33f-788f-7fdd-e053-2a95a90a5f572026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi Benefit Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company66c41b24-d394-6609-e053-2a91aa0a0a2c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus 3 in 1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6fab2eb-da5c-749f-e053-2995a90a13572026-01-08WarningsExact identifier
application number: M021
Crest Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company85477763-1db5-482f-90e5-e71f5c1b47652026-01-08WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf9b31f6b-6b3f-abe0-e053-6294a90acb252026-01-08WarningsExact identifier
application number: M021
Crest Complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc367c2cc-5e0f-bc4e-e053-2995a90a2e2c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f29f95-81b9-3989-e053-2a95a90af3a62026-01-08WarningsExact 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