opalescence whitening cool mint

Generic: sodium fluoride

Labeler: ultradent products, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name opalescence whitening cool mint
Generic Name sodium fluoride
Labeler ultradent products, inc.
Dosage Form GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients

sodium fluoride 1.1 mg/g

Manufacturer
Ultradent Products, Inc.

Identifiers & Regulatory

Product NDC 51206-314
Product ID 51206-314_44e7d0ed-3c38-5889-e063-6294a90afcca
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2025-09-23

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51206314
Hyphenated Format 51206-314

Supplemental Identifiers

RxCUI
416783
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 opalescence whitening cool mint (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 1.1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51206-314-01) / 133 g in 1 TUBE
  • 12 CARTON in 1 PACKAGE, COMBINATION (51206-314-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51206-314-03) / 28 g in 1 TUBE
  • 24 CARTON in 1 PACKAGE, COMBINATION (51206-314-04) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE
source: ndc

Packages (4)

51206-314-01 1 TUBE in 1 CARTON (51206-314-01) / 133 g in 1 TUBE 51206-314-02 12 CARTON in 1 PACKAGE, COMBINATION (51206-314-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 51206-314-03 1 TUBE in 1 CARTON (51206-314-03) / 28 g in 1 TUBE 51206-314-04 24 CARTON in 1 PACKAGE, COMBINATION (51206-314-04) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE

Ingredients (1)

sodium fluoride (1.1 mg/g)

Linked Drug Pages (1)

Opalescence Whitening Cool Mint ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "44e7d0ed-3c38-5889-e063-6294a90afcca", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["416783"], "spl_set_id": ["44e7d0ed-3c37-5889-e063-6294a90afcca"], "manufacturer_name": ["Ultradent Products, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51206-314-01)  / 133 g in 1 TUBE", "package_ndc": "51206-314-01", "marketing_start_date": "20250923"}, {"sample": false, "description": "12 CARTON in 1 PACKAGE, COMBINATION (51206-314-02)  / 1 TUBE in 1 CARTON / 133 g in 1 TUBE", "package_ndc": "51206-314-02", "marketing_start_date": "20250923"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51206-314-03)  / 28 g in 1 TUBE", "package_ndc": "51206-314-03", "marketing_start_date": "20250923"}, {"sample": false, "description": "24 CARTON in 1 PACKAGE, COMBINATION (51206-314-04)  / 1 TUBE in 1 CARTON / 28 g in 1 TUBE", "package_ndc": "51206-314-04", "marketing_start_date": "20250923"}], "brand_name": "Opalescence Whitening Cool Mint", "product_id": "51206-314_44e7d0ed-3c38-5889-e063-6294a90afcca", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "51206-314", "generic_name": "Sodium Fluoride", "labeler_name": "Ultradent Products, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Opalescence Whitening", "brand_name_suffix": "Cool Mint", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "1.1 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250923", "listing_expiration_date": "20261231"}