Home NDC 63783-011 DOCTORS CHOICE
Product NDC 63783-011
11-digit product format 637830011
Labeler code 63783
Product ID 63783-011_3fd28457-0095-43d8-af46-e080d18f5d36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name STANOUS 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
Substance STANNOUS FLUORIDE
Active strength .12 g/120g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 63783-011 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63783-011 63783-011-04 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DOCTORS CHOICE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE .12 g/120g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3FTR44B32Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237847 Internal RxNorm lookup 1037030 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63783-011-04 DOCTORS CHOICE 120 g in 1 BOTTLE, DISPENSING GEL, DENTIFRICE 120 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded STANNOUS FLUORIDE ACTIVE INGREDIENT 3FTR44B32Q DOCTORS CHOICE (STANOUS FLUORIDE) GEL, DENTIFRICE DOCTORS CHOICE (STANNOUS FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 FLUORIDE ION ACTIVE MOIETY Q80VPU408O DOCTORS CHOICE (STANOUS FLUORIDE) GEL, DENTIFRICE DOCTORS CHOICE (STANNOUS FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOCTORS 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 INGREDIENT S38J6RZN16 DOCTORS CHOICE (STANOUS FLUORIDE) GEL, DENTIFRICE DOCTORS CHOICE (STANNOUS FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E DOCTORS 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 NDC Dashboard title SPL version Validation Dashboard ZIP 63783-011 DOCTORS CHOICE (STANOUS FLUORIDE) GEL, DENTIFRICE DOCTORS CHOICE (STANNOUS FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 9 Current NDC, Legacy NDC, 1 package rows 20250101_901f1d20-94e8-4931-9779-9fbbe40fdd5d.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63783-011-04 63783001104 120 g in 1 BOTTLE, DISPENSING (63783-011-04) 120 g 1989-01-01 0000-00-00 No No Current