FDA.reportPublic FDA data

PRO Gel 5000

Product NDC
61578-215
11-digit product format
615780215
Labeler code
61578
Product ID
61578-215_424ae751-1f8e-4e67-ba2e-b368d447053e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
DENTAL ALLIANCE HOLDINGS LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-05-10
Substance
SODIUM FLUORIDE
Active strength
5000 ug/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRO Gel 5000
Brand name suffix
Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5000 ug/g

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
f127e236-5207-948b-e053-2a95a90ab740Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61578-215-012024-01-31C16284748780-11030e365-6640-111a-e063-dadaa90a10e2Gel 5000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61578-215-01PRO Gel 5000Mint68 g in 1 TUBE, WITH APPLICATORGEL, DENTIFRICE683

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61578-215PRO GEL 5000 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE PRO GEL 5000 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE [DENTAL ALLIANCE HOLDINGS LLC]2Current NDC, Legacy NDC, 1 package rows20240202_f127e236-5207-948b-e053-2a95a90ab740.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
PRO Gel 5000 MintSODIUM FLUORIDEDENTAL ALLIANCE HOLDINGS LLCf127e236-5207-948b-e053-2a95a90ab7402025-12-29Warnings, Adverse reactionsExact identifier
ndc (product): 61578-215

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
392038sodium fluoride 1.1 % ToothpastePSNf127e236-5207-948b-e053-2a95a90ab7403
392038sodium fluoride 0.011 MG/MG ToothpasteSCDf127e236-5207-948b-e053-2a95a90ab7403
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYf127e236-5207-948b-e053-2a95a90ab7403
392038sodium fluoride 1.1 % Dental GelSYf127e236-5207-948b-e053-2a95a90ab7403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61578-215-016157802150168 g in 1 TUBE, WITH APPLICATOR (61578-215-01) 68 g2022-05-100000-00-00NoNoCurrent