sodium fluoride

Generic: toothpaste

Labeler: dukal llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sodium fluoride
Generic Name toothpaste
Labeler dukal llc
Dosage Form CREAM
Routes
ORAL
Active Ingredients

sodium fluoride .22 g/100g

Manufacturer
DUKAL LLC

Identifiers & Regulatory

Product NDC 65517-2000
Product ID 65517-2000_1cbd9395-3d74-b411-e063-6394a90afb29
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Marketing Start 2013-11-13
Marketing End 2026-07-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 655172000
Hyphenated Format 65517-2000

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 sodium fluoride (source: ndc)
Generic Name toothpaste (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .22 g/100g
source: ndc
Packaging
  • 17 g in 1 TUBE (65517-2000-0)
  • 24 g in 1 TUBE (65517-2000-1)
  • 42 g in 1 TUBE (65517-2000-2)
  • 78 g in 1 TUBE (65517-2000-3)
  • 1 TUBE in 1 BOX (65517-2000-4) / 42 g in 1 TUBE
  • 1 TUBE in 1 BOX (65517-2000-5) / 78 g in 1 TUBE
  • 1 TUBE in 1 BOX (65517-2000-6) / 135 g in 1 TUBE
  • 1 TUBE in 1 BOX (65517-2000-7) / 181 g in 1 TUBE
source: ndc

Packages (8)

65517-2000-0 17 g in 1 TUBE (65517-2000-0) 65517-2000-1 24 g in 1 TUBE (65517-2000-1) 65517-2000-2 42 g in 1 TUBE (65517-2000-2) 65517-2000-3 78 g in 1 TUBE (65517-2000-3) 65517-2000-4 1 TUBE in 1 BOX (65517-2000-4) / 42 g in 1 TUBE 65517-2000-5 1 TUBE in 1 BOX (65517-2000-5) / 78 g in 1 TUBE 65517-2000-6 1 TUBE in 1 BOX (65517-2000-6) / 135 g in 1 TUBE 65517-2000-7 1 TUBE in 1 BOX (65517-2000-7) / 181 g in 1 TUBE

Ingredients (1)

sodium fluoride (.22 g/100g)

Linked Drug Pages (1)

Sodium fluoride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1cbd9395-3d74-b411-e063-6394a90afb29", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["245598"], "spl_set_id": ["460c0f54-367a-4300-b066-5071d718ea73"], "manufacturer_name": ["DUKAL LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "17 g in 1 TUBE (65517-2000-0)", "package_ndc": "65517-2000-0", "marketing_end_date": "20260731", "marketing_start_date": "20150219"}, {"sample": false, "description": "24 g in 1 TUBE (65517-2000-1)", "package_ndc": "65517-2000-1", "marketing_end_date": "20260731", "marketing_start_date": "20150219"}, {"sample": false, "description": "42 g in 1 TUBE (65517-2000-2)", "package_ndc": "65517-2000-2", "marketing_end_date": "20260731", "marketing_start_date": "20150219"}, {"sample": false, "description": "78 g in 1 TUBE (65517-2000-3)", "package_ndc": "65517-2000-3", "marketing_end_date": "20260731", "marketing_start_date": "20150219"}, {"sample": false, "description": "1 TUBE in 1 BOX (65517-2000-4)  / 42 g in 1 TUBE", "package_ndc": "65517-2000-4", "marketing_end_date": "20260731", "marketing_start_date": "20150219"}, {"sample": false, "description": "1 TUBE in 1 BOX (65517-2000-5)  / 78 g in 1 TUBE", "package_ndc": "65517-2000-5", "marketing_end_date": "20260714", "marketing_start_date": "20150219"}, {"sample": false, "description": "1 TUBE in 1 BOX (65517-2000-6)  / 135 g in 1 TUBE", "package_ndc": "65517-2000-6", "marketing_end_date": "20260519", "marketing_start_date": "20150219"}, {"sample": false, "description": "1 TUBE in 1 BOX (65517-2000-7)  / 181 g in 1 TUBE", "package_ndc": "65517-2000-7", "marketing_end_date": "20260731", "marketing_start_date": "20150219"}], "brand_name": "Sodium fluoride", "product_id": "65517-2000_1cbd9395-3d74-b411-e063-6394a90afb29", "dosage_form": "CREAM", "product_ndc": "65517-2000", "generic_name": "Toothpaste", "labeler_name": "DUKAL LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sodium fluoride", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".22 g/100g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20260731", "marketing_start_date": "20131113"}