Amerfresh Toothpowder

Product NDC
85162-007
11-digit product format
851620007
Labeler code
85162
Product ID
85162-007_4cb875fc-cd0c-7d69-e063-6294a90ab865
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
POWDER
Route
TOPICAL
Labeler
Yangzhou ONE & ONLY Personal Care Products Co., LTD
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-13
Substance
SODIUM FLUORIDE
Active strength
.1 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amerfresh Toothpowder
Listing expiration
2027-12-31

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
85162-007-01Amerfresh Toothpowder454 g in 1 PACKAGEPOWDER4542
85162-007-01Amerfresh Toothpowder40 in 1 CARTONPOWDER402
85162-007-02Amerfresh Toothpowder50 in 1 BOXPOWDER502
85162-007-02Amerfresh Toothpowder4 in 1 CARTONPOWDER42

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN1cacf93e-aa60-4717-87ab-0568a701a4f32
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD1cacf93e-aa60-4717-87ab-0568a701a4f32
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY1cacf93e-aa60-4717-87ab-0568a701a4f32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85162-007-018516200070140 PACKAGE in 1 CARTON (85162-007-01) / 454 g in 1 PACKAGE40 package2025-08-13NoNoCurrent
85162-007-02851620007024 BOX in 1 CARTON (85162-007-02) / 50 POUCH in 1 BOX / 57 g in 1 POUCH4 box2025-08-13NoNoCurrent