FDA.reportPublic FDA data

Twilight Peppermint with Vanilla and Lavender

Product NDC
72164-000
Requested package NDC
72164-000-01
11-digit product format
721640000
Labeler code
72164
Product ID
72164-000_ebe74164-255c-60e3-e053-2a95a90adb64
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form
PASTE
Route
DENTAL
Labeler
Smiletwice, Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-05-18
Marketing end
0000-00-00
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50 mg/g; 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72164-00072164-000-01IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72164-000-002025-01-30C16284748780-12cef2736-9d07-d83d-e063-dadaa90ab31fTwilight Peppermint with Vanilla and Lavender Toothpaste
72164-000-012025-01-30C16284748780-12cef2736-9d07-d83d-e063-dadaa90ab31fTwilight Peppermint with Vanilla and Lavender Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72164-000-00Twilight Peppermint with Vanilla and Lavender96 g in 1 TUBEPASTE966
72164-000-00Twilight Peppermint with Vanilla and Lavender2 in 1 BOXPASTE26
72164-000-014 Pack96 g in 1 TUBEPASTE192 g50 mg in 1g6
72164-000-01Twilight Peppermint with Vanilla and Lavender96 g in 1 TUBEPASTE966
72164-000-01The Duo96 g in 1 TUBEPASTE96 g50 mg in 1g6
72164-000-02Mini Duo23 g in 1 TUBEPASTE23 g50 mg in 1g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72164-0004 PACK (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]6Legacy NDC20231221_c3707c03-3761-4901-89c4-11d214c9287d.zip
72164-000THE DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]6Legacy NDC20231221_4c10df9f-cc42-41ba-968e-0f4470536e3d.zip
72164-000TWILIGHT PEPPERMINT WITH VANILLA AND LAVENDER (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [SMILETWICE, INC.]6Legacy NDC, 3 package rows20221027_4df95d75-e7f6-4d7a-86cf-5feeccfff4f1.zip
72164-000MINI DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]3Legacy NDC20231221_99509d36-cae4-43a7-9ae7-74c101b1bee9.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 5 % / sodium fluoride 0.24 % ToothpastePSNc3707c03-3761-4901-89c4-11d214c9287d6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN4df95d75-e7f6-4d7a-86cf-5feeccfff4f16
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD4c10df9f-cc42-41ba-968e-0f4470536e3d6
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDc3707c03-3761-4901-89c4-11d214c9287d6
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD4df95d75-e7f6-4d7a-86cf-5feeccfff4f16
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYc3707c03-3761-4901-89c4-11d214c9287d6
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY4c10df9f-cc42-41ba-968e-0f4470536e3d6
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY4df95d75-e7f6-4d7a-86cf-5feeccfff4f16
1038929Pot 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 ToothpasteSYc3707c03-3761-4901-89c4-11d214c9287d6
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY4df95d75-e7f6-4d7a-86cf-5feeccfff4f16
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYc3707c03-3761-4901-89c4-11d214c9287d6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY4df95d75-e7f6-4d7a-86cf-5feeccfff4f16
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 % ) ToothpasteSY4df95d75-e7f6-4d7a-86cf-5feeccfff4f16
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY4c10df9f-cc42-41ba-968e-0f4470536e3d6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYc3707c03-3761-4901-89c4-11d214c9287d6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY4df95d75-e7f6-4d7a-86cf-5feeccfff4f16
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYc3707c03-3761-4901-89c4-11d214c9287d6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY4c10df9f-cc42-41ba-968e-0f4470536e3d6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN99509d36-cae4-43a7-9ae7-74c101b1bee93
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD99509d36-cae4-43a7-9ae7-74c101b1bee93
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY99509d36-cae4-43a7-9ae7-74c101b1bee93
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY99509d36-cae4-43a7-9ae7-74c101b1bee93
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY99509d36-cae4-43a7-9ae7-74c101b1bee93
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY99509d36-cae4-43a7-9ae7-74c101b1bee93
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY99509d36-cae4-43a7-9ae7-74c101b1bee93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72164-000-017216400000196 g in 1 TUBE (72164-000-01) 96 g2018-05-180000-00-00NoNoCurrent