enamelon

Generic: stannous fluoride

Labeler: premier dental products company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name enamelon
Generic Name stannous fluoride
Labeler premier dental products company
Dosage Form PASTE, DENTIFRICE
Routes
DENTAL
Active Ingredients

stannous fluoride .00454 g/g

Manufacturer
Premier Dental Products Company

Identifiers & Regulatory

Product NDC 48783-520
Product ID 48783-520_4847e71b-2083-917b-e063-6394a90a2df0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2027-12-31
Marketing Start 2014-01-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 48783520
Hyphenated Format 48783-520

Supplemental Identifiers

RxCUI
416784
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 enamelon (source: ndc)
Generic Name stannous fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • .00454 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (48783-520-43) / 122 g in 1 TUBE
source: ndc

Packages (1)

48783-520-43 1 TUBE in 1 CARTON (48783-520-43) / 122 g in 1 TUBE

Ingredients (1)

stannous fluoride (.00454 g/g)

Linked Drug Pages (1)

Enamelon ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "4847e71b-2083-917b-e063-6394a90a2df0", "openfda": {"unii": ["3FTR44B32Q"], "rxcui": ["416784"], "spl_set_id": ["1626375a-f78b-4192-b7f3-ca932acab7fb"], "manufacturer_name": ["Premier Dental Products Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (48783-520-43)  / 122 g in 1 TUBE", "package_ndc": "48783-520-43", "marketing_start_date": "20140101"}], "brand_name": "Enamelon", "product_id": "48783-520_4847e71b-2083-917b-e063-6394a90a2df0", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "48783-520", "generic_name": "stannous fluoride", "labeler_name": "Premier Dental Products Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Enamelon", "active_ingredients": [{"name": "STANNOUS FLUORIDE", "strength": ".00454 g/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140101", "listing_expiration_date": "20271231"}