teeth whitening kit

Generic: teeth whitening kit

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

Drug Facts

Product Profile

Brand Name teeth whitening kit
Generic Name teeth whitening 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 83778-002
Product ID 83778-002_29c01cdf-48e8-77a6-e063-6294a90af25c
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2027-12-31
Marketing Start 2023-11-05

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 83778002
Hyphenated Format 83778-002

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 teeth whitening kit (source: ndc)
Generic Name teeth whitening kit (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 (83778-002-01)
source: ndc

Packages (1)

83778-002-01 6 mL in 1 BOTTLE (83778-002-01)

Ingredients (3)

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

Linked Drug Pages (1)

Teeth Whitening Kit ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "29c01cdf-48e8-77a6-e063-6294a90af25c", "openfda": {"unii": ["5OEJ6FAL6C", "EE90ONI6FF", "91D9GV0Z28"], "spl_set_id": ["0973b73d-5de9-0986-e063-6294a90a5917"], "manufacturer_name": ["Jiangxi Dentalbright Technology Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 mL in 1 BOTTLE (83778-002-01)", "package_ndc": "83778-002-01", "marketing_start_date": "20231105"}], "brand_name": "Teeth Whitening Kit", "product_id": "83778-002_29c01cdf-48e8-77a6-e063-6294a90af25c", "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": "83778-002", "generic_name": "Teeth Whitening Kit", "labeler_name": "Jiangxi Dentalbright Technology Co., Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Teeth Whitening 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"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20231105", "listing_expiration_date": "20271231"}