mipaste one

Generic: mipaste one

Labeler: gc america inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name mipaste one
Generic Name mipaste one
Labeler gc america inc.
Dosage Form PASTE, DENTIFRICE
Routes
DENTAL
Active Ingredients

potassium nitrate 5 g/100g, sodium fluoride .24 g/100g

Manufacturer
GC America Inc.

Identifiers & Regulatory

Product NDC 61596-400
Product ID 61596-400_4651d664-464b-05c1-e063-6394a90a565e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2022-02-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61596400
Hyphenated Format 61596-400

Supplemental Identifiers

RxCUI
1038929
UNII
RU45X2JN0Z 8ZYQ1474W7

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 mipaste one (source: ndc)
Generic Name mipaste one (source: ndc)
Application Number M021 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 5 g/100g
  • .24 g/100g
source: ndc
Packaging
  • 10 BOX in 1 BOX (61596-400-10) / 1 TUBE in 1 BOX (61596-400-41) / 46 g in 1 TUBE (61596-400-40)
source: ndc

Packages (1)

61596-400-10 10 BOX in 1 BOX (61596-400-10) / 1 TUBE in 1 BOX (61596-400-41) / 46 g in 1 TUBE (61596-400-40)

Ingredients (2)

potassium nitrate (5 g/100g) sodium fluoride (.24 g/100g)

Linked Drug Pages (1)

MIPaste One ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "4651d664-464b-05c1-e063-6394a90a565e", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "rxcui": ["1038929"], "spl_set_id": ["d71f8e6e-7005-4b3e-e053-2995a90a6789"], "manufacturer_name": ["GC America Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOX in 1 BOX (61596-400-10)  / 1 TUBE in 1 BOX (61596-400-41)  / 46 g in 1 TUBE (61596-400-40)", "package_ndc": "61596-400-10", "marketing_start_date": "20220203"}], "brand_name": "MIPaste One", "product_id": "61596-400_4651d664-464b-05c1-e063-6394a90a565e", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "61596-400", "generic_name": "MIPaste One", "labeler_name": "GC America Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MIPaste One", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "5 g/100g"}, {"name": "SODIUM FLUORIDE", "strength": ".24 g/100g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220203", "listing_expiration_date": "20261231"}