opal by opalescence original

Generic: sodium fluoride

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

Drug Facts

Product Profile

Brand Name opal by opalescence original
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 51206-312
Product ID 51206-312_37cbe83e-8ca1-40c6-e063-6394a90a1886
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2023-11-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51206312
Hyphenated Format 51206-312

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 opal by opalescence original (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 (51206-312-01) / 133 g in 1 TUBE
  • 3 CARTON in 1 PACKAGE, COMBINATION (51206-312-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE
source: ndc

Packages (2)

51206-312-01 1 TUBE in 1 CARTON (51206-312-01) / 133 g in 1 TUBE 51206-312-02 3 CARTON in 1 PACKAGE, COMBINATION (51206-312-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE

Ingredients (1)

sodium fluoride (1.1 mg/g)

Linked Drug Pages (1)

Opal by Opalescence Original ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "37cbe83e-8ca1-40c6-e063-6394a90a1886", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["1044547"], "spl_set_id": ["5c3bf8fc-2e8f-4a58-bcbf-e47540072a49"], "manufacturer_name": ["Ultradent Products, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51206-312-01)  / 133 g in 1 TUBE", "package_ndc": "51206-312-01", "marketing_end_date": "20290221", "marketing_start_date": "20231119"}, {"sample": false, "description": "3 CARTON in 1 PACKAGE, COMBINATION (51206-312-02)  / 1 TUBE in 1 CARTON / 133 g in 1 TUBE", "package_ndc": "51206-312-02", "marketing_end_date": "20290221", "marketing_start_date": "20231119"}], "brand_name": "Opal by Opalescence Original", "product_id": "51206-312_37cbe83e-8ca1-40c6-e063-6394a90a1886", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "51206-312", "generic_name": "Sodium Fluoride", "labeler_name": "Ultradent Products, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Opal by Opalescence Original", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "1.1 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231119", "listing_expiration_date": "20261231"}