FDA.reportPublic FDA data

Early Bird Wintergreen and Peppermint

Product NDC
72164-001
11-digit product format
721640001
Labeler code
72164
Product ID
72164-001_ebe7cc38-e054-1d14-e053-2a95a90aad8f
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72164-001-002025-01-30C16284748780-12cef2736-9d1e-d83d-e063-dadaa90ab31fEarly Bird Wintergreen and Peppermint Toothpaste
72164-001-012025-01-30C16284748780-12cef2736-9d1e-d83d-e063-dadaa90ab31fEarly Bird Wintergreen and Peppermint Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72164-001-00Early Bird Wintergreen and Peppermint96 g in 1 TUBEPASTE966
72164-001-00Early Bird Wintergreen and Peppermint2 in 1 BOXPASTE26
72164-001-01The Duo96 g in 1 TUBEPASTE96 g50 mg in 1g6
72164-001-014 Pack96 g in 1 TUBEPASTE192 g50 mg in 1g6
72164-001-01Early Bird Wintergreen and Peppermint96 g in 1 TUBEPASTE966
72164-001-02Mini Duo23 g in 1 TUBEPASTE23 g50 mg in 1g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72164-0014 PACK (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]6Legacy NDC20231221_c3707c03-3761-4901-89c4-11d214c9287d.zip
72164-001EARLY BIRD WINTERGREEN AND PEPPERMINT (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [SMILETWICE, INC.]6Legacy NDC, 3 package rows20221027_10743960-2a60-4a2f-a024-8e3b79b0d118.zip
72164-001THE DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]6Legacy NDC20231221_4c10df9f-cc42-41ba-968e-0f4470536e3d.zip
72164-001MINI 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 % ToothpastePSN10743960-2a60-4a2f-a024-8e3b79b0d1186
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 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD10743960-2a60-4a2f-a024-8e3b79b0d1186
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
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 ToothpasteSY10743960-2a60-4a2f-a024-8e3b79b0d1186
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 ToothpasteSY10743960-2a60-4a2f-a024-8e3b79b0d1186
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
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY10743960-2a60-4a2f-a024-8e3b79b0d1186
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 % ) 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 % (fluoride ion 0.15 % ) ToothpasteSYc3707c03-3761-4901-89c4-11d214c9287d6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY10743960-2a60-4a2f-a024-8e3b79b0d1186
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 % ToothpasteSY10743960-2a60-4a2f-a024-8e3b79b0d1186
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
72164-001-007216400010096 g in 1 TUBE96 gHistorical
72164-001-017216400010196 g in 1 TUBE (72164-001-01) 96 g2018-05-180000-00-00NoNoCurrent
72164-001-027216400010223 g in 1 TUBE23 gHistorical