FDA.reportPublic FDA data

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
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
86279b4d-82e5-45b5-9ba7-94fe3620b850Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85162-001-01AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1441
85162-001-01AMERFRESH FLUORIDE gel17 g in 1 TUBEPASTE, DENTIFRICE171
85162-001-02AMERFRESH FLUORIDE gel24 g in 1 TUBEPASTE, DENTIFRICE241
85162-001-02AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1441
85162-001-03AMERFRESH FLUORIDE gel43 g in 1 TUBEPASTE, DENTIFRICE431
85162-001-03AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1441
85162-001-04AMERFRESH FLUORIDE gel78 g in 1 TUBEPASTE, DENTIFRICE781
85162-001-04AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1441
85162-001-05AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1441
85162-001-05AMERFRESH FLUORIDE gel85 g in 1 TUBEPASTE, DENTIFRICE851
85162-001-06AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1441
85162-001-06AMERFRESH FLUORIDE gel142 g in 1 TUBEPASTE, DENTIFRICE1421
85162-001-07AMERFRESH FLUORIDE gel7 g in 1 POUCHPASTE, DENTIFRICE71
85162-001-07AMERFRESH FLUORIDE gel1000 in 1 BOXPASTE, DENTIFRICE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85162-001AMERFRESH FLUORIDE GEL (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD]1Current NDC, 14 package rows20250117_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 48 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Murchison Hume Dental KitSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.b1a442e1-86cf-cba6-e053-2995a90a593a2023-12-20WarningsExact identifier
application number: M021
United Airlines Polaris Kit with ColgateSODIUM MONOFLUOROPHOSPHATEBuzz Export Services Pty Ltd (Buzz Products)de4564a4-1012-baad-e053-2a95a90a11b72023-12-20WarningsExact identifier
application number: M021
Orajel Complete ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.daebd16f-d278-446d-8b7a-33add5a74fdd2023-12-19WarningsExact identifier
application number: M021
Orajel Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEChurch & Dwight Co., Inc.7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb2023-12-19WarningsExact identifier
application number: M021
ORTHO GUARDSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticals8d3e0dd0-b584-413b-adf3-5c2d05ab72dd2023-12-17WarningsExact identifier
application number: M021
Beyond Activated Coconut Charcoal and Sea SaltSODIUM FLUORIDEBeyond International Incd075fa15-7309-0c10-e053-2995a90a7c952023-11-28WarningsExact identifier
application number: M021
Pro-Den RxSTANNOUS FLUORIDEDen-mat Holdings, Llc9036aa8a-59b1-41b0-b3cb-529d3303a1c02023-11-20WarningsExact identifier
application number: M021
FluoridexSTANNOUS FLUORIDE RINSEDEN-MAT HOLDINGS, LLC5e81f073-c0ca-aa38-e053-2a91aa0ab37b2023-11-20WarningsExact identifier
application number: M021
Hello Vitamin C WhiteningSODIUM FLUORIDEColgate-Palmolive Company38a0276e-910c-527d-1736-65928b9d4ca42023-11-20WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDELG H&H CO., LTD.0abaf99b-9547-46ae-e063-6394a90a6c152023-11-17WarningsExact identifier
application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLCe3356374-befa-41b0-ab0f-edfd5a0626012023-11-16WarningsExact identifier
application number: M021
ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC421fc2f0-b118-4e7a-a399-ba4780028c542023-11-16WarningsExact identifier
application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDESODIUM FLUORIDEUniversal Distribution Center LLC3411924d-1002-460c-83e8-c0c7fbff9ad12023-11-16WarningsExact identifier
application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2023-11-16WarningsExact identifier
application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2023-11-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.0989936c-237d-dc63-e063-6294a90a885f2023-11-07WarningsExact identifier
application number: M021
Eurofresh WhiteningSODIUM FLUORIDEFarmasi US LLCb56b2b55-e3a4-785a-e053-2a95a90a7abf2023-11-05WarningsExact identifier
application number: M021
Farmasi WhiteningSODIUM FLUORIDEFarmasi US LLC25b3608e-abed-41ca-9971-21981b8a46102023-11-05WarningsExact identifier
application number: M021
United Airlines Therabody UPP KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalfb6c355b-a67d-c4b4-e053-6394a90a0e662023-10-26WarningsExact identifier
application number: M021
United Dental KitSODIUM MONOFLUOROPHOSPHATEWessco International7f348fe7-9918-4934-bed0-f0a77c09d0462023-10-26WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN86279b4d-82e5-45b5-9ba7-94fe3620b8501
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD86279b4d-82e5-45b5-9ba7-94fe3620b8501
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY86279b4d-82e5-45b5-9ba7-94fe3620b8501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85162-001-0185162000101144 TUBE in 1 BOX (85162-001-01) / 17 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-001-0285162000102144 TUBE in 1 BOX (85162-001-02) / 24 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-001-0385162000103144 TUBE in 1 BOX (85162-001-03) / 43 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-001-0485162000104144 TUBE in 1 BOX (85162-001-04) / 78 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-001-0585162000105144 TUBE in 1 BOX (85162-001-05) / 85 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-001-0685162000106144 TUBE in 1 BOX (85162-001-06) / 142 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-001-07851620001071000 POUCH in 1 BOX (85162-001-07) / 7 g in 1 POUCH1000 pouch2025-01-16NoNoCurrent