pro-den rx

Generic: stannous fluoride

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

Drug Facts

Product Profile

Brand Name pro-den rx
Generic Name stannous fluoride
Labeler den-mat holdings, llc
Dosage Form RINSE
Routes
ORAL
Active Ingredients

stannous fluoride 1.53 mg/g

Manufacturer
Den-mat Holdings, Llc

Identifiers & Regulatory

Product NDC 59883-720
Product ID 59883-720_0a95fcbe-e811-031d-e063-6294a90aec1b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2008-10-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59883720
Hyphenated Format 59883-720

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 pro-den rx (source: ndc)
Generic Name stannous fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.53 mg/g
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59883-720-08) / 283.5 g in 1 BOTTLE
source: ndc

Packages (1)

59883-720-08 1 BOTTLE in 1 CARTON (59883-720-08) / 283.5 g in 1 BOTTLE

Ingredients (1)

stannous fluoride (1.53 mg/g)

Linked Drug Pages (1)

Pro-Den Rx ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0a95fcbe-e811-031d-e063-6294a90aec1b", "openfda": {"unii": ["3FTR44B32Q"], "spl_set_id": ["9036aa8a-59b1-41b0-b3cb-529d3303a1c0"], "manufacturer_name": ["Den-mat Holdings, Llc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59883-720-08)  / 283.5 g in 1 BOTTLE", "package_ndc": "59883-720-08", "marketing_start_date": "20081031"}], "brand_name": "Pro-Den Rx", "product_id": "59883-720_0a95fcbe-e811-031d-e063-6294a90aec1b", "dosage_form": "RINSE", "product_ndc": "59883-720", "generic_name": "Stannous Fluoride", "labeler_name": "Den-mat Holdings, Llc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pro-Den Rx", "active_ingredients": [{"name": "STANNOUS FLUORIDE", "strength": "1.53 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20081031", "listing_expiration_date": "20261231"}