FDA.reportPublic FDA data

Alpha-Pro

Product NDC
55346-0942
11-digit product format
553460942
Labeler code
55346
Product ID
55346-0942_42c8ae03-7559-51a8-e063-6394a90ab69e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride and Hydrofluoric Acid
Dosage form
GEL
Route
DENTAL
Labeler
Dental Technologies, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-04-01
Substance
HYDROFLUORIC ACID; SODIUM FLUORIDE
Active strength
4.4; 7.9 mg/g; 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
Alpha-Pro
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE4.4 mg/g
HYDROFLUORIC ACID7.9 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RGL5YE86CZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1297381Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
efe3646d-9eb1-4a49-aeb4-c4c224056851Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55346-0942-1Alpha-Pro497 g in 1 BOTTLEGEL4973

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROFLUORIC ACIDACTIVE INGREDIENTRGL5YE86CZALPHA-PRO (SODIUM FLUORIDE AND HYDROFLUORIC ACID) GEL [DENTAL TECHNOLOGIES, INC.]1
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7ALPHA-PRO (SODIUM FLUORIDE AND HYDROFLUORIC ACID) GEL [DENTAL TECHNOLOGIES, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OALPHA-PRO (SODIUM FLUORIDE AND HYDROFLUORIC ACID) GEL [DENTAL TECHNOLOGIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55346-0942ALPHA-PRO (SODIUM FLUORIDE AND HYDROFLUORIC ACID) GEL [DENTAL TECHNOLOGIES, INC.]2Current NDC, Legacy NDC, 1 package rows20171212_efe3646d-9eb1-4a49-aeb4-c4c224056851.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
Alpha-ProSODIUM FLUORIDE AND HYDROFLUORIC ACIDDental Technologies, Inc.efe3646d-9eb1-4a49-aeb4-c4c2240568512025-11-04Warnings, Adverse reactionsExact identifier
ndc (product): 55346-0942

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297381hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral GelPSNefe3646d-9eb1-4a49-aeb4-c4c2240568513
1297381hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral GelSCDefe3646d-9eb1-4a49-aeb4-c4c2240568513
1297381hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral GelSYefe3646d-9eb1-4a49-aeb4-c4c2240568513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55346-0942-155346094201497 g in 1 BOTTLE (55346-0942-1) 497 g2013-04-010000-00-00NoNoCurrent