amerfresh toothpowder

Generic: sodium fluoride

Labeler: yangzhou one & only personal care products co., ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name amerfresh toothpowder
Generic Name sodium fluoride
Labeler yangzhou one & only personal care products co., ltd
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

sodium fluoride .1 g/100g

Manufacturer
Yangzhou ONE & ONLY Personal Care Products Co., LTD

Identifiers & Regulatory

Product NDC 85162-007
Product ID 85162-007_3c3be779-3a33-058b-e063-6294a90a34a6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2025-08-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85162007
Hyphenated Format 85162-007

Supplemental Identifiers

RxCUI
245598
UNII
8ZYQ1474W7

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amerfresh toothpowder (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 g/100g
source: ndc
Packaging
  • 40 PACKAGE in 1 CARTON (85162-007-01) / 454 g in 1 PACKAGE
  • 4 BOX in 1 CARTON (85162-007-02) / 50 POUCH in 1 BOX / 57 g in 1 POUCH
source: ndc

Packages (2)

85162-007-01 40 PACKAGE in 1 CARTON (85162-007-01) / 454 g in 1 PACKAGE 85162-007-02 4 BOX in 1 CARTON (85162-007-02) / 50 POUCH in 1 BOX / 57 g in 1 POUCH

Ingredients (1)

sodium fluoride (.1 g/100g)

Linked Drug Pages (1)

Amerfresh Toothpowder ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3c3be779-3a33-058b-e063-6294a90a34a6", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["245598"], "spl_set_id": ["1cacf93e-aa60-4717-87ab-0568a701a4f3"], "manufacturer_name": ["Yangzhou ONE & ONLY Personal Care Products Co., LTD"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 PACKAGE in 1 CARTON (85162-007-01)  / 454 g in 1 PACKAGE", "package_ndc": "85162-007-01", "marketing_start_date": "20250813"}, {"sample": false, "description": "4 BOX in 1 CARTON (85162-007-02)  / 50 POUCH in 1 BOX / 57 g in 1 POUCH", "package_ndc": "85162-007-02", "marketing_start_date": "20250813"}], "brand_name": "Amerfresh Toothpowder", "product_id": "85162-007_3c3be779-3a33-058b-e063-6294a90a34a6", "dosage_form": "POWDER", "product_ndc": "85162-007", "generic_name": "Sodium Fluoride", "labeler_name": "Yangzhou ONE & ONLY Personal Care Products Co., LTD", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Amerfresh Toothpowder", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".1 g/100g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250813", "listing_expiration_date": "20261231"}