ortho guard

Generic: sodium fluoride

Labeler: massco dental a division of dunagin pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name ortho guard
Generic Name sodium fluoride
Labeler massco dental a division of dunagin pharmaceuticals
Dosage Form GEL, DENTIFRICE
Routes
ORAL
Active Ingredients

sodium fluoride 4.4 mg/10mL

Manufacturer
Massco Dental A Division of Dunagin Pharmaceuticals

Identifiers & Regulatory

Product NDC 63783-401
Product ID 63783-401_2a1d770f-d9a7-4980-a1f2-cf4df96d0f40
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 1989-01-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63783401
Hyphenated Format 63783-401

Supplemental Identifiers

UNII
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 ortho guard (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4.4 mg/10mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (63783-401-16)
source: ndc

Packages (1)

63783-401-16 473 mL in 1 BOTTLE (63783-401-16)

Ingredients (1)

sodium fluoride (4.4 mg/10mL)

Linked Drug Pages (1)

ORTHO GUARD ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a1d770f-d9a7-4980-a1f2-cf4df96d0f40", "openfda": {"unii": ["8ZYQ1474W7"], "spl_set_id": ["8d3e0dd0-b584-413b-adf3-5c2d05ab72dd"], "manufacturer_name": ["Massco Dental A Division of Dunagin Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (63783-401-16)", "package_ndc": "63783-401-16", "marketing_start_date": "19890101"}], "brand_name": "ORTHO GUARD", "product_id": "63783-401_2a1d770f-d9a7-4980-a1f2-cf4df96d0f40", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "63783-401", "generic_name": "SODIUM FLUORIDE", "labeler_name": "Massco Dental A Division of Dunagin Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ORTHO GUARD", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "4.4 mg/10mL"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19890101", "listing_expiration_date": "20261231"}