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 GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients

stannous fluoride .4 mg/100g

Manufacturer
Dharma Research, Inc.

Identifiers & Regulatory

Product NDC 53045-271
Product ID 53045-271_91060eb1-2d2e-4100-912f-05e7b46c9ae3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2015-08-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53045271
Hyphenated Format 53045-271

Supplemental Identifiers

RxCUI
237847
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
  • .4 mg/100g
source: ndc
Packaging
  • 122 g in 1 TUBE (53045-271-04)
source: ndc

Packages (1)

53045-271-04 122 g in 1 TUBE (53045-271-04)

Ingredients (1)

stannous fluoride (.4 mg/100g)

Linked Drug Pages (1)

Ionite H ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "91060eb1-2d2e-4100-912f-05e7b46c9ae3", "openfda": {"unii": ["3FTR44B32Q"], "rxcui": ["237847"], "spl_set_id": ["042636cf-8b61-4022-b0a1-af09c06b145b"], "manufacturer_name": ["Dharma Research, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "122 g in 1 TUBE (53045-271-04)", "package_ndc": "53045-271-04", "marketing_start_date": "20150802"}], "brand_name": "Ionite H", "product_id": "53045-271_91060eb1-2d2e-4100-912f-05e7b46c9ae3", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "53045-271", "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": ".4 mg/100g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150802", "listing_expiration_date": "20261231"}