teethwhitening kit

Generic: teethwhitening kit

Labeler: jiangxi dentalbright technology co., ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name teethwhitening kit
Generic Name teethwhitening kit
Labeler jiangxi dentalbright technology co., ltd.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

phthalimidoperoxycaproic acid 12 g/100mL, potassium citrate 3 g/100mL, tribasic calcium phosphate 1 g/100mL

Manufacturer
Jiangxi Dentalbright Technology Co., Ltd.

Identifiers & Regulatory

Product NDC 83778-012
Product ID 83778-012_29ae5783-e7c6-a892-e063-6394a90a47e2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2024-12-14

Pharmacologic Class

Classes
acidifying activity [moa] anti-coagulant [epc] calcium chelating activity [moa] calculi dissolution agent [epc] decreased coagulation factor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83778012
Hyphenated Format 83778-012

Supplemental Identifiers

UNII
5OEJ6FAL6C EE90ONI6FF 91D9GV0Z28

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 teethwhitening kit (source: ndc)
Generic Name teethwhitening kit (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 12 g/100mL
  • 3 g/100mL
  • 1 g/100mL
source: ndc
Packaging
  • 6 mL in 1 BOTTLE (83778-012-01)
source: ndc

Packages (1)

83778-012-01 6 mL in 1 BOTTLE (83778-012-01)

Ingredients (3)

phthalimidoperoxycaproic acid (12 g/100mL) potassium citrate (3 g/100mL) tribasic calcium phosphate (1 g/100mL)

Linked Drug Pages (1)

TeethWhitening Kit ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "29ae5783-e7c6-a892-e063-6394a90a47e2", "openfda": {"unii": ["5OEJ6FAL6C", "EE90ONI6FF", "91D9GV0Z28"], "spl_set_id": ["29393313-217a-dc3a-e063-6294a90addb1"], "manufacturer_name": ["Jiangxi Dentalbright Technology Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 mL in 1 BOTTLE (83778-012-01)", "package_ndc": "83778-012-01", "marketing_start_date": "20241214"}], "brand_name": "TeethWhitening Kit", "product_id": "83778-012_29ae5783-e7c6-a892-e063-6394a90a47e2", "dosage_form": "CREAM", "pharm_class": ["Acidifying Activity [MoA]", "Anti-coagulant [EPC]", "Calcium Chelating Activity [MoA]", "Calculi Dissolution Agent [EPC]", "Decreased Coagulation Factor Activity [PE]"], "product_ndc": "83778-012", "generic_name": "TeethWhitening Kit", "labeler_name": "Jiangxi Dentalbright Technology Co., Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TeethWhitening Kit", "active_ingredients": [{"name": "PHTHALIMIDOPEROXYCAPROIC ACID", "strength": "12 g/100mL"}, {"name": "POTASSIUM CITRATE", "strength": "3 g/100mL"}, {"name": "TRIBASIC CALCIUM PHOSPHATE", "strength": "1 g/100mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241214", "listing_expiration_date": "20261231"}