FDA.reportPublic FDA data

Twice Science Wellness Cooling Spearmint Eucalyptus

Product NDC
72164-004
11-digit product format
721640004
Labeler code
72164
Product ID
72164-004_ba10d2eb-7f52-63e6-e053-2995a90aa0d1
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Smiletwice, Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-01-02
Marketing end
0000-00-00
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72164-004IInactivated by FDA2026-10-05
excluded packagepackage72164-00472164-004-01IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72164-004-01Twice Science Wellness Cooling Spearmint Eucalyptus96 g in 1 TUBEPASTE, DENTIFRICE962
72164-004-01Twice Science Wellness Cooling Spearmint Eucalyptus1 in 1 BOXPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72164-004TWICE SCIENCE WELLNESS COOLING SPEARMINT EUCALYPTUS (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [SMILETWICE, INC.]2Legacy NDC, 2 package rows20231221_ba10e2fa-dffc-846f-e053-2a95a90a1885.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNba10e2fa-dffc-846f-e053-2a95a90a18852
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDba10e2fa-dffc-846f-e053-2a95a90a18852
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYba10e2fa-dffc-846f-e053-2a95a90a18852
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYba10e2fa-dffc-846f-e053-2a95a90a18852
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYba10e2fa-dffc-846f-e053-2a95a90a18852
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYba10e2fa-dffc-846f-e053-2a95a90a18852
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYba10e2fa-dffc-846f-e053-2a95a90a18852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72164-004-01721640004011 TUBE in 1 BOX (72164-004-01) > 96 g in 1 TUBE1 tube2021-01-020000-00-00NoNoCurrent