SprinJene Natural

Product NDC
63404-1984
11-digit product format
634041984
Labeler code
63404
Product ID
63404-1984_4e23f203-d473-4e73-ab56-d9270e4c49e9
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Health and Natural Beauty USA Corp
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-20
Substance
POTASSIUM NITRATE
Active strength
50 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SprinJene Natural
Brand name suffix
Sensitivity and Gum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z
Rxcui312544

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63404-1984-12025-07-08C16284748780-1f386c64a-3a0d-0266-e053-dadaa90a7c1aSprinJene Natural ® Sensitivity & Gum
63404-1984-12023-01-30C16284748780-1f386c64a-3a0d-0266-e053-dadaa90a7c1aSprinJene Natural ® Sensitivity & Gum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63404-1984-1SprinJene Natural Sensitivity and Gum142 g in 1 TUBEPASTE, DENTIFRICE1422
63404-1984-1SprinJene Natural Sensitivity and Gum1 in 1 CARTONPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63404-1984SPRINJENE NATURAL SENSITIVITY AND GUM (POTASSIUM NITRATE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]1Current NDC, Legacy NDC, 2 package rows20210220_3cb23e36-0e8c-4172-b4ae-859b58a2739f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312544potassium nitrate 5 % ToothpastePSN3cb23e36-0e8c-4172-b4ae-859b58a2739f2
312544potassium nitrate 0.05 MG/MG ToothpasteSCD3cb23e36-0e8c-4172-b4ae-859b58a2739f2
312544K+ nitrate 0.05 MG/MG ToothpasteSY3cb23e36-0e8c-4172-b4ae-859b58a2739f2
312544Pot nitrate 0.05 MG/MG ToothpasteSY3cb23e36-0e8c-4172-b4ae-859b58a2739f2
312544potassium nitrate 5 % ToothpasteSY3cb23e36-0e8c-4172-b4ae-859b58a2739f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63404-1984-1634041984011 TUBE in 1 CARTON (63404-1984-1) / 142 g in 1 TUBE1 tube2021-02-200000-00-00NoNoCurrent