FDA.reportPublic FDA data

Top Quality Mfg APF

Product NDC
69301-034
Requested package NDC
69301-034-15
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
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
6 g/454g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69301-03469301-034-15DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7TOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OTOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]1
Magnesium Aluminum SilicateINACTIVE INGREDIENT6M3P64V0NCTOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]1
Phosphoric AcidINACTIVE INGREDIENTE4GA8884NNTOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHTOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUTOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RTOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEETOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]1
XylitolINACTIVE INGREDIENTVCQ006KQ1ETOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]1

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.]3Legacy 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