FDA.reportPublic FDA data

Sodium Fluoride 5000 ppm Dry Mouth

Product NDC
11527-755
11-digit product format
115270755
Labeler code
11527
Product ID
11527-755_6bf92fe3-34f9-4d29-8312-3f65639c05ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Sheffield Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-01-08
Substance
SODIUM FLUORIDE
Active strength
6.1 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 Dry Mouth
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE6.1 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
cbc67f03-55c4-4781-ba37-87c737b60282Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-755-34Sodium Fluoride 5000 ppm Dry Mouth100 mL in 1 TUBEGEL, DENTIFRICE1002
11527-755-34Sodium Fluoride 5000 ppm Dry Mouth1 in 1 CARTONGEL, DENTIFRICE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-755-34ML - Milliliter11527-7552b635e5b-0e52-44e0-abb9-b1c87cb831d712021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-755SODIUM FLUORIDE 5000 PPM DRY MOUTH (SODIUM FLUORIDE) GEL, DENTIFRICE [SHEFFIELD PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20210305_cbc67f03-55c4-4781-ba37-87c737b60282.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 Dry MouthSODIUM FLUORIDESheffield Pharmaceuticals LLCcbc67f03-55c4-4781-ba37-87c737b602822021-03-02Warnings, Adverse reactionsExact identifier
ndc (product): 11527-755

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
392038sodium fluoride 1.1 % ToothpastePSNcbc67f03-55c4-4781-ba37-87c737b602822
392038sodium fluoride 0.011 MG/MG ToothpasteSCDcbc67f03-55c4-4781-ba37-87c737b602822
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYcbc67f03-55c4-4781-ba37-87c737b602822
392038sodium fluoride 1.1 % Dental GelSYcbc67f03-55c4-4781-ba37-87c737b602822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-755-34115270755341 TUBE in 1 CARTON (11527-755-34) / 100 mL in 1 TUBE1 tube2021-01-080000-00-00NoNoCurrent