FDA.reportPublic FDA data

Sodium Fluoride 5000 ppm Spearmint

Product NDC
11527-750
11-digit product format
115270750
Labeler code
11527
Product ID
11527-750_86c0981d-f4cc-4136-a38e-ef6f86a272e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Sheffield Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-03-26
Substance
SODIUM FLUORIDE
Active strength
6 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Fluoride 5000 ppm Spearmint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui392038

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-750-43Sodium Fluoride 5000 ppm Spearmint100 mL in 1 TUBEPASTE, DENTIFRICE1003
11527-750-43Sodium Fluoride 5000 ppm Spearmint1 in 1 CARTONPASTE, DENTIFRICE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-750-43ML - Milliliter11527-7507effbf10-b145-4dd3-ab40-5ee0f6eccc0e12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-750SODIUM FLUORIDE 5000 PPM SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE SODIUM FLUORIDE 5000 PPM FRUIT (SODIUM FLUORIDE) PASTE, DENTIFRICE [SHEFFIELD PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 2 package rows20220128_a73f72b9-dbcd-4eed-9c20-46a9e8daf859.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
392038sodium fluoride 1.1 % ToothpastePSNa73f72b9-dbcd-4eed-9c20-46a9e8daf8593
392038sodium fluoride 0.011 MG/MG ToothpasteSCDa73f72b9-dbcd-4eed-9c20-46a9e8daf8593
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYa73f72b9-dbcd-4eed-9c20-46a9e8daf8593
392038sodium fluoride 1.1 % Dental GelSYa73f72b9-dbcd-4eed-9c20-46a9e8daf8593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-750-43115270750431 TUBE in 1 CARTON (11527-750-43) / 100 mL in 1 TUBE1 tube2020-03-260000-00-00NoNoCurrent