fluoridex

Generic: stannous fluoride rinse

Labeler: den-mat holdings, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name fluoridex
Generic Name stannous fluoride rinse
Labeler den-mat holdings, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

stannous fluoride 1.53 mg/g

Manufacturer
DEN-MAT HOLDINGS, LLC

Identifiers & Regulatory

Product NDC 59883-004
Product ID 59883-004_0a96438c-733f-8bce-e063-6394a90a0ce7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2016-01-11

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59883004
Hyphenated Format 59883-004

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 fluoridex (source: ndc)
Generic Name stannous fluoride rinse (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.53 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (59883-004-01) / 310 g in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

59883-004-01 1 BOTTLE, PLASTIC in 1 BOX (59883-004-01) / 310 g in 1 BOTTLE, PLASTIC

Ingredients (1)

stannous fluoride (1.53 mg/g)

Linked Drug Pages (1)

Fluoridex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0a96438c-733f-8bce-e063-6394a90a0ce7", "openfda": {"unii": ["3FTR44B32Q"], "spl_set_id": ["5e81f073-c0ca-aa38-e053-2a91aa0ab37b"], "manufacturer_name": ["DEN-MAT HOLDINGS, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (59883-004-01)  / 310 g in 1 BOTTLE, PLASTIC", "package_ndc": "59883-004-01", "marketing_start_date": "20160111"}], "brand_name": "Fluoridex", "product_id": "59883-004_0a96438c-733f-8bce-e063-6394a90a0ce7", "dosage_form": "LIQUID", "product_ndc": "59883-004", "generic_name": "Stannous Fluoride Rinse", "labeler_name": "DEN-MAT HOLDINGS, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fluoridex", "active_ingredients": [{"name": "STANNOUS FLUORIDE", "strength": "1.53 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160111", "listing_expiration_date": "20261231"}