MIPaste

Product NDC
61596-437
11-digit product format
615960437
Labeler code
61596
Product ID
61596-437_b192ae37-ad33-5e68-e053-2a95a90a1443
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride, potassium nitrate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
GC America Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-07-03
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
0 g/g; g/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61596-437-412022-01-28C16284748780-1d6a99b39-e3a8-a426-e053-dadaa90af4c24d63020f-934c-2af4-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61596-437-40MIPasteONE46 g in 1 TUBEPASTE, DENTIFRICE465
61596-437-41MIPasteONE1 in 1 BOXPASTE, DENTIFRICE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61596-437MIPASTE ONE (SODIUM FLUORIDE, POTASSIUM NITRATE) PASTE, DENTIFRICE [GC AMERICA INC.]5Legacy NDC, 2 package rows20201014_4d63020f-934c-2af4-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61596-437-406159604374046 g in 1 TUBE46 gHistorical
61596-437-41615960437411 TUBE in 1 BOX (61596-437-41) > 46 g in 1 TUBE (61596-437-40) 1 tube2017-07-030000-00-00NoNoCurrent