home care fluoride

Generic: stannous fluoride

Labeler: dental technologies, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name home care fluoride
Generic Name stannous fluoride
Labeler dental technologies, inc.
Dosage Form GEL
Routes
DENTAL ORAL
Active Ingredients

stannous fluoride .969 mg/g

Manufacturer
Dental Technologies, Inc.

Identifiers & Regulatory

Product NDC 55346-0401
Product ID 55346-0401_42c8aa46-9e15-ec47-e063-6294a90a06c3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 1999-12-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 553460401
Hyphenated Format 55346-0401

Supplemental Identifiers

UNII
3FTR44B32Q

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 home care fluoride (source: ndc)
Generic Name stannous fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
DENTAL ORAL
source: ndc

Resolved Composition

Strengths
  • .969 mg/g
source: ndc
Packaging
  • 121.9 g in 1 TUBE (55346-0401-1)
source: ndc

Packages (1)

55346-0401-1 121.9 g in 1 TUBE (55346-0401-1)

Ingredients (1)

stannous fluoride (.969 mg/g)

Linked Drug Pages (1)

Home Care Fluoride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL", "ORAL"], "spl_id": "42c8aa46-9e15-ec47-e063-6294a90a06c3", "openfda": {"unii": ["3FTR44B32Q"], "spl_set_id": ["15bdc03e-2cc7-4b7d-96fc-4f3236ed5c75"], "manufacturer_name": ["Dental Technologies, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "121.9 g in 1 TUBE (55346-0401-1)", "package_ndc": "55346-0401-1", "marketing_start_date": "19991231"}], "brand_name": "Home Care Fluoride", "product_id": "55346-0401_42c8aa46-9e15-ec47-e063-6294a90a06c3", "dosage_form": "GEL", "product_ndc": "55346-0401", "generic_name": "Stannous Fluoride", "labeler_name": "Dental Technologies, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Home Care Fluoride", "active_ingredients": [{"name": "STANNOUS FLUORIDE", "strength": ".969 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19991231", "listing_expiration_date": "20261231"}