Supersmile

Product NDC
53567-0738
Requested package NDC
53567-0738-4
11-digit product format
535670738
Labeler code
53567
Product ID
53567-0738_e6fdf6a0-179b-a7ac-e053-2995a90a8236
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL; ORAL
Labeler
Robell Research, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-11-04
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

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53567-0738-4535670738041 TUBE in 1 BOX (53567-0738-4) > 6 g in 1 TUBE1 tube2018-08-070000-00-00YesNoCurrent