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

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 Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui245598

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

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