pearl white

Generic: potassium nitrate, sodium fluoride

Labeler: beyond international inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pearl white
Generic Name potassium nitrate, sodium fluoride
Labeler beyond international inc.
Dosage Form PASTE, DENTIFRICE
Routes
DENTAL
Active Ingredients

potassium nitrate 50 mg/g, sodium fluoride 1 mg/g

Manufacturer
Beyond International Inc.

Identifiers & Regulatory

Product NDC 42199-006
Product ID 42199-006_0b3e6b1d-3644-3f2c-e063-6394a90a25a1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Marketing Start 2017-06-12
Marketing End 2026-11-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42199006
Hyphenated Format 42199-006

Supplemental Identifiers

UNII
RU45X2JN0Z 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 pearl white (source: ndc)
Generic Name potassium nitrate, sodium fluoride (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (42199-006-05) / 120 g in 1 TUBE
  • 1 TUBE in 1 CARTON (42199-006-06) / 40 g in 1 TUBE
source: ndc

Packages (2)

42199-006-05 1 TUBE in 1 CARTON (42199-006-05) / 120 g in 1 TUBE 42199-006-06 1 TUBE in 1 CARTON (42199-006-06) / 40 g in 1 TUBE

Ingredients (2)

potassium nitrate (50 mg/g) sodium fluoride (1 mg/g)

Linked Drug Pages (1)

Pearl White ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "0b3e6b1d-3644-3f2c-e063-6394a90a25a1", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "spl_set_id": ["51c79544-9536-5863-e054-00144ff8d46c"], "manufacturer_name": ["Beyond International Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (42199-006-05)  / 120 g in 1 TUBE", "package_ndc": "42199-006-05", "marketing_end_date": "20261127", "marketing_start_date": "20170612"}, {"sample": false, "description": "1 TUBE in 1 CARTON (42199-006-06)  / 40 g in 1 TUBE", "package_ndc": "42199-006-06", "marketing_end_date": "20261127", "marketing_start_date": "20170612"}], "brand_name": "Pearl White", "product_id": "42199-006_0b3e6b1d-3644-3f2c-e063-6394a90a25a1", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "42199-006", "generic_name": "Potassium nitrate, Sodium fluoride", "labeler_name": "Beyond International Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pearl White", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "50 mg/g"}, {"name": "SODIUM FLUORIDE", "strength": "1 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20261127", "marketing_start_date": "20170612"}