opalescence whitening

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
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 51206-302
Product ID 51206-302_43d0d640-82ea-c153-e063-6294a90abff1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 1994-07-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51206302
Hyphenated Format 51206-302

Supplemental Identifiers

RxCUI
1044547
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 (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 BOX (51206-302-06) / 133 g in 1 TUBE
  • 1 TUBE in 1 BOX (51206-302-07) / 28.35 g in 1 TUBE
  • 3 BOX in 1 PACKAGE, COMBINATION (51206-302-08) / 1 TUBE in 1 BOX / 133 g in 1 TUBE
  • 12 BOX in 1 PACKAGE, COMBINATION (51206-302-09) / 1 TUBE in 1 BOX / 133 g in 1 TUBE
  • 24 BOX in 1 PACKAGE, COMBINATION (51206-302-10) / 1 TUBE in 1 BOX / 28.35 g in 1 TUBE
  • 6 BOX in 1 PACKAGE, COMBINATION (51206-302-11) / 1 TUBE in 1 BOX / 133 g in 1 TUBE
source: ndc

Packages (6)

51206-302-06 1 TUBE in 1 BOX (51206-302-06) / 133 g in 1 TUBE 51206-302-07 1 TUBE in 1 BOX (51206-302-07) / 28.35 g in 1 TUBE 51206-302-08 3 BOX in 1 PACKAGE, COMBINATION (51206-302-08) / 1 TUBE in 1 BOX / 133 g in 1 TUBE 51206-302-09 12 BOX in 1 PACKAGE, COMBINATION (51206-302-09) / 1 TUBE in 1 BOX / 133 g in 1 TUBE 51206-302-10 24 BOX in 1 PACKAGE, COMBINATION (51206-302-10) / 1 TUBE in 1 BOX / 28.35 g in 1 TUBE 51206-302-11 6 BOX in 1 PACKAGE, COMBINATION (51206-302-11) / 1 TUBE in 1 BOX / 133 g in 1 TUBE

Ingredients (1)

sodium fluoride (1.1 mg/g)

Linked Drug Pages (1)

Opalescence Whitening ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "43d0d640-82ea-c153-e063-6294a90abff1", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["1044547"], "spl_set_id": ["d07f842e-b6f1-4ae1-b576-f542ecd02dd4"], "manufacturer_name": ["Ultradent Products, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (51206-302-06)  / 133 g in 1 TUBE", "package_ndc": "51206-302-06", "marketing_end_date": "20300930", "marketing_start_date": "19940701"}, {"sample": false, "description": "1 TUBE in 1 BOX (51206-302-07)  / 28.35 g in 1 TUBE", "package_ndc": "51206-302-07", "marketing_end_date": "20300930", "marketing_start_date": "19940701"}, {"sample": false, "description": "3 BOX in 1 PACKAGE, COMBINATION (51206-302-08)  / 1 TUBE in 1 BOX / 133 g in 1 TUBE", "package_ndc": "51206-302-08", "marketing_end_date": "20300930", "marketing_start_date": "20160601"}, {"sample": false, "description": "12 BOX in 1 PACKAGE, COMBINATION (51206-302-09)  / 1 TUBE in 1 BOX / 133 g in 1 TUBE", "package_ndc": "51206-302-09", "marketing_end_date": "20300930", "marketing_start_date": "20160601"}, {"sample": false, "description": "24 BOX in 1 PACKAGE, COMBINATION (51206-302-10)  / 1 TUBE in 1 BOX / 28.35 g in 1 TUBE", "package_ndc": "51206-302-10", "marketing_end_date": "20300903", "marketing_start_date": "20160601"}, {"sample": false, "description": "6 BOX in 1 PACKAGE, COMBINATION (51206-302-11)  / 1 TUBE in 1 BOX / 133 g in 1 TUBE", "package_ndc": "51206-302-11", "marketing_end_date": "20300930", "marketing_start_date": "20200824"}], "brand_name": "Opalescence Whitening", "product_id": "51206-302_43d0d640-82ea-c153-e063-6294a90abff1", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "51206-302", "generic_name": "Sodium Fluoride", "labeler_name": "Ultradent Products, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Opalescence Whitening", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "1.1 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19940701", "listing_expiration_date": "20261231"}