Top Quality Mfg APF

Product NDC
69301-034
11-digit product format
693010034
Labeler code
69301
Product ID
69301-034_d60637c5-dee7-8455-e053-2995a90a3c29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
DENTAL
Labeler
Top Quality Manufacturing, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-05-01
Substance
SODIUM FLUORIDE
Active strength
5.6 g/454g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Top Quality Mfg APF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5.6 g/454g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui245593

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69301-034-15Top Quality Mfg APF454 g in 1 BOTTLE, PLASTICGEL4543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69301-034TOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]3Current NDC, Legacy NDC, 1 package rows20220121_cc819868-9633-4b5f-800f-698f936e6a75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245593sodium fluoride 2 % Dental GelPSNcc819868-9633-4b5f-800f-698f936e6a753
245593sodium fluoride 0.02 MG/MG Oral GelSCDcc819868-9633-4b5f-800f-698f936e6a753
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSYcc819868-9633-4b5f-800f-698f936e6a753
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSYcc819868-9633-4b5f-800f-698f936e6a753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69301-034-1569301003415454 g in 1 BOTTLE, PLASTIC (69301-034-15) 454 g2014-05-010000-00-00NoNoCurrent