ionite h

Generic: stannous fluoride

Labeler: dharma research, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name ionite h
Generic Name stannous fluoride
Labeler dharma research, inc.
Dosage Form MOUTHWASH
Routes
DENTAL
Active Ingredients

stannous fluoride .63 mg/100mL

Manufacturer
Dharma Research, Inc.

Identifiers & Regulatory

Product NDC 53045-275
Product ID 53045-275_48ad63b9-3911-40fe-8bd2-bcace77e5713
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2015-08-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53045275
Hyphenated Format 53045-275

Supplemental Identifiers

RxCUI
583459
UPC
0353045000994
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 ionite h (source: ndc)
Generic Name stannous fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • .63 mg/100mL
source: ndc
Packaging
  • 296 mL in 1 BOTTLE, DISPENSING (53045-275-10)
source: ndc

Packages (1)

53045-275-10 296 mL in 1 BOTTLE, DISPENSING (53045-275-10)

Ingredients (1)

stannous fluoride (.63 mg/100mL)

Linked Drug Pages (1)

Ionite H ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "48ad63b9-3911-40fe-8bd2-bcace77e5713", "openfda": {"upc": ["0353045000994"], "unii": ["3FTR44B32Q"], "rxcui": ["583459"], "spl_set_id": ["5c312b36-07f4-406e-b3d3-c6d1e964635d"], "manufacturer_name": ["Dharma Research, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "296 mL in 1 BOTTLE, DISPENSING (53045-275-10)", "package_ndc": "53045-275-10", "marketing_start_date": "20150803"}], "brand_name": "Ionite H", "product_id": "53045-275_48ad63b9-3911-40fe-8bd2-bcace77e5713", "dosage_form": "MOUTHWASH", "product_ndc": "53045-275", "generic_name": "Stannous Fluoride", "labeler_name": "Dharma Research, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ionite H", "active_ingredients": [{"name": "STANNOUS FLUORIDE", "strength": ".63 mg/100mL"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150803", "listing_expiration_date": "20261231"}