FDA.reportPublic FDA data

Teeth Whitening Kit

Product NDC
83778-002
11-digit product format
837780002
Labeler code
83778
Product ID
83778-002_29c01cdf-48e8-77a6-e063-6294a90af25c
Type
HUMAN OTC DRUG
Nonproprietary name
Teeth Whitening Kit
Dosage form
CREAM
Route
TOPICAL
Labeler
Jiangxi Dentalbright Technology Co., Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-11-05
Substance
PHTHALIMIDOPEROXYCAPROIC ACID; POTASSIUM CITRATE; TRIBASIC CALCIUM PHOSPHATE
Active strength
12; 3; 1 g/100mL; g/100mL; g/100mL
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Teeth Whitening Kit
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHTHALIMIDOPEROXYCAPROIC ACID12 g/100mL
POTASSIUM CITRATE3 g/100mL
TRIBASIC CALCIUM PHOSPHATE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5OEJ6FAL6C, EE90ONI6FF, 91D9GV0Z28

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83778-002-012026-01-03C16284748780-12cef2736-a6a7-d83d-e063-dadaa90ab31f83778-002 Update
83778-002-012025-01-30C16284748780-12cef2736-a6a7-d83d-e063-dadaa90ab31f83778-002 Update

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83778-002-01Teeth Whitening Kit6 mL in 1 BOTTLECREAM62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83778-002TEETH WHITENING KIT CREAM [NANCHANG DENTAL BRIGHT TECHNOLOGY CO.,LTD.]1Current NDC, 1 package rows20231106_0973b73d-5de9-0986-e063-6294a90a5917.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83778-002-01837780002016 mL in 1 BOTTLE (83778-002-01) 6 ml2023-11-05NoNoCurrent