BLUE Save the Animals

Product NDC
51009-916
11-digit product format
510090916
Labeler code
51009
Product ID
51009-916_ebd85879-2244-4f40-85b7-d951815ba22b
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
CREAM
Route
DENTAL
Labeler
Tom's of Maine, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-06-30
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mg/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51009-916DDiscontinued by firm2026-10-12
excluded packagepackage51009-91651009-916-51DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-916BLUE SAVE THE ANIMALS (SODIUM MONOFLUOROPHOSPHATE) CREAM [TOM'S OF MAINE, INC.]5Legacy NDC20241120_1c84fb97-5d7a-4def-b0dd-0bf993d49a42.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51009-916-5151009091651144 g in 1 TUBE (51009-916-51) 144 g2021-06-300000-00-00NoNoCurrent