FDA.reportPublic FDA data

The Duo

Product NDC
72164-100
11-digit product format
721640100
Labeler code
72164
Product ID
72164-100_ebe7d5ac-3abd-da00-e053-2a95a90aa674
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form
KIT
Labeler
Smiletwice, Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-09-14
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72164-100-022025-01-30C16284748780-12cef2736-a5d5-d83d-e063-dadaa90ab31fThe Duo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72164-000-01The Duo96 g in 1 TUBEPASTE96 g50 mg in 1g6
72164-001-01The Duo96 g in 1 TUBEPASTE96 g50 mg in 1g6
72164-100-02The Duo1 in 1 KITKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72164-100THE DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]6Legacy NDC, 3 package rows20231221_4c10df9f-cc42-41ba-968e-0f4470536e3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN4c10df9f-cc42-41ba-968e-0f4470536e3d6
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD4c10df9f-cc42-41ba-968e-0f4470536e3d6
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY4c10df9f-cc42-41ba-968e-0f4470536e3d6
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY4c10df9f-cc42-41ba-968e-0f4470536e3d6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY4c10df9f-cc42-41ba-968e-0f4470536e3d6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY4c10df9f-cc42-41ba-968e-0f4470536e3d6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY4c10df9f-cc42-41ba-968e-0f4470536e3d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72164-000-017216400000196 g in 1 TUBE96 gHistorical
72164-001-017216400010196 g in 1 TUBE96 gHistorical
72164-100-02721640100021 KIT in 1 KIT (72164-100-02) * 96 g in 1 TUBE (72164-000-01) * 96 g in 1 TUBE (72164-001-01) 1 kit2018-09-140000-00-00NoNoCurrent