Professional whitening tooth

Product NDC
82168-004
11-digit product format
821680004
Labeler code
82168
Product ID
82168-004_4c16da29-b13d-52ff-e063-6394a90aedda
Type
HUMAN OTC DRUG
Nonproprietary name
Professional whitening toothpaste
Dosage form
PASTE
Route
DENTAL
Labeler
Guangzhou City Caiye Cosmetics CO., Ltd
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-13
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
.76 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Professional whitening tooth
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.76 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82168-004-012026-01-29C16284748780-149896155-a96e-586f-e063-e6dba90add9082168-004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82168-004-01Professional whitening tooth100 g in 1 BOXPASTE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82168-004PROFESSIONAL WHITENING TOOTH (PROFESSIONAL WHITENING TOOTHPASTE) PASTE [GUANGZHOU CITY CAIYE COSMETICS CO., LTD]1Current NDC, 1 package rows20241215_291eba71-14da-fac3-e063-6294a90aa3cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN291eba71-14da-fac3-e063-6294a90aa3cc2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD291eba71-14da-fac3-e063-6294a90aa3cc2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY291eba71-14da-fac3-e063-6294a90aa3cc2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY291eba71-14da-fac3-e063-6294a90aa3cc2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY291eba71-14da-fac3-e063-6294a90aa3cc2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY291eba71-14da-fac3-e063-6294a90aa3cc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82168-004-0182168000401100 g in 1 BOX (82168-004-01) 100 g2024-12-13NoNoHistorical