FDA.reportPublic FDA data

Sodium Fluoride 5000 ppm Fruit

Product NDC
11527-730
11-digit product format
115270730
Labeler code
11527
Product ID
11527-730_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 Fruit
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
392038Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a73f72b9-dbcd-4eed-9c20-46a9e8daf859Available on FDA.report

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
11527-730-44Sodium Fluoride 5000 ppm Fruit1 in 1 CARTONPASTE, DENTIFRICE13
11527-730-44Sodium Fluoride 5000 ppm Fruit100 mL in 1 TUBEPASTE, DENTIFRICE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-730-44ML - Milliliter11527-730ab653b7c-1362-47e2-93ad-ce8ccc5234d912020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-730SODIUM 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Fluoride 5000 ppm FruitSODIUM FLUORIDESheffield Pharmaceuticals LLCa73f72b9-dbcd-4eed-9c20-46a9e8daf8592022-01-19Warnings, Adverse reactionsExact identifier
ndc (product): 11527-730

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
11527-730-44115270730441 TUBE in 1 CARTON (11527-730-44) / 100 mL in 1 TUBE1 tube2020-03-260000-00-00NoNoCurrent