FDA.reportPublic FDA data

DOCTORS CHOICE

Product NDC
63783-012
11-digit product format
637830012
Labeler code
63783
Product ID
63783-012_85b4477a-484d-472f-bf8f-68610017df7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
STANNOUS FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
ORAL
Labeler
Massco Dental A Division of Dunagin Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1989-01-01
Marketing end
2023-12-31
Substance
STANNOUS FLUORIDE
Active strength
0 g/120g
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63783-012DDiscontinued by firm2026-10-02
excluded packagepackage63783-01263783-012-04DDiscontinued by firm2026-10-02

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct63783-012EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63783-01263783-012-04EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32QDOCTORS CHOICE (STANOUS FLUORIDE) GEL, DENTIFRICE DOCTORS CHOICE (STANNOUS FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]4
FLUORIDE IONACTIVE MOIETYQ80VPU408ODOCTORS CHOICE (STANOUS FLUORIDE) GEL, DENTIFRICE DOCTORS CHOICE (STANNOUS FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCTORS CHOICE (STANOUS FLUORIDE) GEL, DENTIFRICE DOCTORS CHOICE (STANNOUS FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]4
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16DOCTORS CHOICE (STANOUS FLUORIDE) GEL, DENTIFRICE DOCTORS CHOICE (STANNOUS FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]4
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EDOCTORS CHOICE (STANOUS FLUORIDE) GEL, DENTIFRICE DOCTORS CHOICE (STANNOUS FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63783-012DOCTORS CHOICE (STANOUS FLUORIDE) GEL, DENTIFRICE DOCTORS CHOICE (STANNOUS FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]9Legacy NDC20250101_901f1d20-94e8-4931-9779-9fbbe40fdd5d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63783-012-0463783001204120 g in 1 BOTTLE, DISPENSING (63783-012-04) 120 g1989-01-010000-00-00NoNoCurrent