amerfresh fluoride gel

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 fluoride gel
Generic Name sodium fluoride
Labeler yangzhou one & only personal care products co., ltd
Dosage Form PASTE, DENTIFRICE
Routes
TOPICAL
Active Ingredients

sodium fluoride .1 g/100g

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

Identifiers & Regulatory

Product NDC 85162-001
Product ID 85162-001_2bce0b25-f314-443b-e063-6394a90a4102
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2025-01-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85162001
Hyphenated Format 85162-001

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 fluoride gel (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
  • 144 TUBE in 1 BOX (85162-001-01) / 17 g in 1 TUBE
  • 144 TUBE in 1 BOX (85162-001-02) / 24 g in 1 TUBE
  • 144 TUBE in 1 BOX (85162-001-03) / 43 g in 1 TUBE
  • 144 TUBE in 1 BOX (85162-001-04) / 78 g in 1 TUBE
  • 144 TUBE in 1 BOX (85162-001-05) / 85 g in 1 TUBE
  • 144 TUBE in 1 BOX (85162-001-06) / 142 g in 1 TUBE
  • 1000 POUCH in 1 BOX (85162-001-07) / 7 g in 1 POUCH
source: ndc

Packages (7)

85162-001-01 144 TUBE in 1 BOX (85162-001-01) / 17 g in 1 TUBE 85162-001-02 144 TUBE in 1 BOX (85162-001-02) / 24 g in 1 TUBE 85162-001-03 144 TUBE in 1 BOX (85162-001-03) / 43 g in 1 TUBE 85162-001-04 144 TUBE in 1 BOX (85162-001-04) / 78 g in 1 TUBE 85162-001-05 144 TUBE in 1 BOX (85162-001-05) / 85 g in 1 TUBE 85162-001-06 144 TUBE in 1 BOX (85162-001-06) / 142 g in 1 TUBE 85162-001-07 1000 POUCH in 1 BOX (85162-001-07) / 7 g in 1 POUCH

Ingredients (1)

sodium fluoride (.1 g/100g)

Linked Drug Pages (1)

AMERFRESH FLUORIDE gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2bce0b25-f314-443b-e063-6394a90a4102", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["245598"], "spl_set_id": ["86279b4d-82e5-45b5-9ba7-94fe3620b850"], "manufacturer_name": ["Yangzhou ONE & ONLY Personal Care Products Co., LTD"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "144 TUBE in 1 BOX (85162-001-01)  / 17 g in 1 TUBE", "package_ndc": "85162-001-01", "marketing_start_date": "20250116"}, {"sample": false, "description": "144 TUBE in 1 BOX (85162-001-02)  / 24 g in 1 TUBE", "package_ndc": "85162-001-02", "marketing_start_date": "20250116"}, {"sample": false, "description": "144 TUBE in 1 BOX (85162-001-03)  / 43 g in 1 TUBE", "package_ndc": "85162-001-03", "marketing_start_date": "20250116"}, {"sample": false, "description": "144 TUBE in 1 BOX (85162-001-04)  / 78 g in 1 TUBE", "package_ndc": "85162-001-04", "marketing_start_date": "20250116"}, {"sample": false, "description": "144 TUBE in 1 BOX (85162-001-05)  / 85 g in 1 TUBE", "package_ndc": "85162-001-05", "marketing_start_date": "20250116"}, {"sample": false, "description": "144 TUBE in 1 BOX (85162-001-06)  / 142 g in 1 TUBE", "package_ndc": "85162-001-06", "marketing_start_date": "20250116"}, {"sample": false, "description": "1000 POUCH in 1 BOX (85162-001-07)  / 7 g in 1 POUCH", "package_ndc": "85162-001-07", "marketing_start_date": "20250116"}], "brand_name": "AMERFRESH FLUORIDE gel", "product_id": "85162-001_2bce0b25-f314-443b-e063-6394a90a4102", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "85162-001", "generic_name": "Sodium Fluoride", "labeler_name": "Yangzhou ONE & ONLY Personal Care Products Co., LTD", "product_type": "HUMAN OTC DRUG", "brand_name_base": "AMERFRESH FLUORIDE gel", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".1 g/100g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250116", "listing_expiration_date": "20261231"}