opal by opalescence complete

Generic: opal by opalescence complete

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

Drug Facts

Product Profile

Brand Name opal by opalescence complete
Generic Name opal by opalescence complete
Labeler ultradent products, inc.
Dosage Form GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients

stannous fluoride 1.1 mg/g

Manufacturer
Ultradent Products, Inc.

Identifiers & Regulatory

Product NDC 51206-313
Product ID 51206-313_37cb56fb-2de8-0628-e063-6394a90a1b56
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2024-10-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51206313
Hyphenated Format 51206-313

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 opal by opalescence complete (source: ndc)
Generic Name opal by opalescence complete (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 (51206-313-01) / 133 g in 1 TUBE
  • 12 CARTON in 1 PACKAGE, COMBINATION (51206-313-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE
source: ndc

Packages (2)

51206-313-01 1 TUBE in 1 CARTON (51206-313-01) / 133 g in 1 TUBE 51206-313-02 12 CARTON in 1 PACKAGE, COMBINATION (51206-313-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE

Ingredients (1)

stannous fluoride (1.1 mg/g)

Linked Drug Pages (1)

Opal by Opalescence Complete ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "37cb56fb-2de8-0628-e063-6394a90a1b56", "openfda": {"unii": ["3FTR44B32Q"], "rxcui": ["416784"], "spl_set_id": ["249cc46a-dad6-0345-e063-6394a90a4447"], "manufacturer_name": ["Ultradent Products, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51206-313-01)  / 133 g in 1 TUBE", "package_ndc": "51206-313-01", "marketing_end_date": "20270814", "marketing_start_date": "20241021"}, {"sample": false, "description": "12 CARTON in 1 PACKAGE, COMBINATION (51206-313-02)  / 1 TUBE in 1 CARTON / 133 g in 1 TUBE", "package_ndc": "51206-313-02", "marketing_end_date": "20270814", "marketing_start_date": "20241021"}], "brand_name": "Opal by Opalescence Complete", "product_id": "51206-313_37cb56fb-2de8-0628-e063-6394a90a1b56", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "51206-313", "generic_name": "Opal by Opalescence Complete", "labeler_name": "Ultradent Products, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Opal by Opalescence Complete", "active_ingredients": [{"name": "STANNOUS FLUORIDE", "strength": "1.1 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241021", "listing_expiration_date": "20261231"}