Alpha-Pro

Product NDC
55346-0943
11-digit product format
553460943
Labeler code
55346
Product ID
55346-0943_42c899b3-99ed-0863-e063-6394a90ad112
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
HYDROFLUORIC ACID4.4 mg/g
SODIUM FLUORIDE7.9 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRGL5YE86CZ, 8ZYQ1474W7
Rxcui1297381

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55346-0943-1Alpha-Pro497 g in 1 BOTTLEGEL4973

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55346-0943ALPHA-PRO (SODIUM FLUORIDE AND HYDROFLUORIC ACID) GEL [DENTAL TECHNOLOGIES, INC.]2Current NDC, Legacy NDC, 1 package rows20171212_a86ec65f-f6e1-474d-aeff-412a4716a92c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297381hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral GelPSNa86ec65f-f6e1-474d-aeff-412a4716a92c3
1297381hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral GelSCDa86ec65f-f6e1-474d-aeff-412a4716a92c3
1297381hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral GelSYa86ec65f-f6e1-474d-aeff-412a4716a92c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55346-0943-155346094301497 g in 1 BOTTLE (55346-0943-1) 497 g2013-04-010000-00-00NoNoCurrent