KIDS CHOICE

Product NDC
63783-007
11-digit product format
637830007
Labeler code
63783
Product ID
63783-007_b6ba8842-04d3-46c8-88c9-846e6063ab63
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 productproduct63783-007DDiscontinued by firm2026-10-05
excluded packagepackage63783-00763783-007-04DDiscontinued by firm2026-10-05

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63783-007-04IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63783-007-04IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63783-007-04IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63783-007-04EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63783-007KIDS CHOICE (STANNOUS FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]11Legacy NDC20250112_cbf7907e-72c7-4328-8bd4-bf70daa35ef9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63783-007-0463783000704120 g in 1 BOTTLE, DISPENSING (63783-007-04) 120 g1989-01-010000-00-00NoNoCurrent