gelato homecare

Generic: stannous fluoride

Labeler: mycone dental supply co., inc dba keystone industries and deepak products inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name gelato homecare
Generic Name stannous fluoride
Labeler mycone dental supply co., inc dba keystone industries and deepak products inc.
Dosage Form GEL
Routes
DENTAL
Active Ingredients

stannous fluoride .116 g/120g

Manufacturer
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

Identifiers & Regulatory

Product NDC 68400-201
Product ID 68400-201_1679a47c-dc75-72ca-e063-6294a90a39c0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2013-01-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68400201
Hyphenated Format 68400-201

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 gelato homecare (source: ndc)
Generic Name stannous fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • .116 g/120g
source: ndc
Packaging
  • 120 g in 1 TUBE (68400-201-04)
source: ndc

Packages (1)

68400-201-04 120 g in 1 TUBE (68400-201-04)

Ingredients (1)

stannous fluoride (.116 g/120g)

Linked Drug Pages (1)

Gelato Homecare ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "1679a47c-dc75-72ca-e063-6294a90a39c0", "openfda": {"unii": ["3FTR44B32Q"], "rxcui": ["237847"], "spl_set_id": ["1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db"], "manufacturer_name": ["Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 g in 1 TUBE (68400-201-04)", "package_ndc": "68400-201-04", "marketing_start_date": "20160901"}], "brand_name": "Gelato Homecare", "product_id": "68400-201_1679a47c-dc75-72ca-e063-6294a90a39c0", "dosage_form": "GEL", "product_ndc": "68400-201", "generic_name": "Stannous Fluoride", "labeler_name": "Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gelato Homecare", "active_ingredients": [{"name": "STANNOUS FLUORIDE", "strength": ".116 g/120g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130105", "listing_expiration_date": "20261231"}