Supersmile

Product NDC
53567-0037
11-digit product format
535670037
Labeler code
53567
Product ID
53567-0037_47e57b98-fb55-24a5-e063-6294a90a785b
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Robell Research, Inc
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-15
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
.14 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
Supersmile
Brand name suffix
Professional Whitening TP Citrus Blast
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.14 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui2695772

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53567-0037-1SupersmileProfessional Whitening TP Citrus Blast40 g in 1 TUBEPASTE, DENTIFRICE403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53567-0037SUPERSMILE PROFESSIONAL WHITENING TP CITRUS BLAST (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC]2Current NDC, 1 package rows20250119_2504686d-b053-51d0-e063-6394a90a789f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2695772sodium monofluorophosphate 0.79 % ToothpastePSN2504686d-b053-51d0-e063-6394a90a789f3
2695772sodium monofluorophosphate 0.0079 MG/MG ToothpasteSCD2504686d-b053-51d0-e063-6394a90a789f3
2695772sodium monofluorophosphate 0.79 % (fluoride ion 0.14 % )ToothpasteSY2504686d-b053-51d0-e063-6394a90a789f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53567-0037-15356700370140 g in 1 TUBE (53567-0037-1) 40 g2024-10-15NoNoHistorical