Wintergreen Peppermint

Product NDC
72164-005
11-digit product format
721640005
Labeler code
72164
Product ID
72164-005_48c69282-189f-8bf2-e063-6394a90acf2a
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Twice Twice LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-01
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.5 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Wintergreen Peppermint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b7beec2-e070-4102-a2a4-68c332fc9fb3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72164-005-00Wintergreen Peppermint96 g in 1 TUBEPASTE, DENTIFRICE965

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72164-005WINTERGREEN PEPPERMINT (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [TWICE TWICE LLC]4Current NDC, Legacy NDC, 1 package rows20250221_7b7beec2-e070-4102-a2a4-68c332fc9fb3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 33 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natural Cherry Honey Herb Throat DropsMENTHOLRicola Ag229a7feb-c646-4557-85e5-0832682ab9262024-12-05WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola Ag0e135eb0-4a40-4930-ade4-fb7df87db1f42024-12-05WarningsExact identifier
application number: M022
Cherry Throat DropsMENTHOLRicola Ag73d767e2-bb80-4eff-8420-500c2a4067aa2024-12-05WarningsExact identifier
application number: M022
COOL RELIEF ORAL ANESTHETICMENTHOLRicola Ag951e9836-e6a3-4094-8a6b-f226c85c897a2024-12-05WarningsExact identifier
application number: M022
COOL RELIEF LEMON FROST ORAL ANESTHETICMENTHOLRicola Ag908f5ce5-94a4-4c35-ae7a-b308ea37fa082024-12-05WarningsExact identifier
application number: M022
ORGANIC PEPPERMINT HERB THROAT DROPSMENTHOLRicola Aga6657ecf-e74a-4912-a68c-73abc456f9e22024-12-05WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola Ag67373cf1-e8c3-4db2-98e1-c88d25a762092024-12-05WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola Ag586b2a46-2673-4f27-a62a-2d48a9b520ab2024-12-05WarningsExact identifier
application number: M022
BERRY MEDLEY THROAT DROPSMENTHOLRicola Aga2bdd035-4678-4cff-b24f-8e2f06acad962024-12-05WarningsExact identifier
application number: M022
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
application number: M022
Orajel Antiseptic Alcohol-Free Mouth Sore RinseHYDROGEN PEROXIDE, MENTHOLChurch & Dwight Co., Inc.99d47d6a-fa2e-d5ee-e053-2995a90aa11d2024-11-27WarningsExact identifier
application number: M022
Orajel 2x Gum Pain Alcohol-FreeMENTHOL AND HYDROGEN PEROXIDEChurch & Dwight Co., Inc.adf37010-922c-4441-93d6-1e1a95025e902024-11-27WarningsExact identifier
application number: M022
Maximum Strength Cold Sore TreatmentCAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUMMeijer Distribution Inc9220772c-b3b7-4855-e053-2a95a90a94f62024-11-27WarningsExact identifier
application number: M022
Peroxyl Mouth Sore Mild MintHYDROGEN PEROXIDEColgate Oral Pharmaceuticals Inc.b1e1b7c9-dea7-4d64-b6a8-5343f41763592024-11-25WarningsExact identifier
application number: M022
NICE SORE THROAT SpearmintPHENOLLeosons Overseas Corp5fc68f04-ec15-11c0-e053-2a91aa0a19522024-11-20WarningsExact identifier
application number: M022
TANAC Oral Pain RelieverBENZOCAINELeosons Overseas Corp81cc61fa-31a7-2214-e053-2a91aa0ae46a2024-11-15WarningsExact identifier
application number: M022
NICE SORE THROAT Honey LemonPHENOLLeosons Overseas Corp601aea98-e6ab-de6f-e053-2a91aa0a824a2024-11-15WarningsExact identifier
application number: M022
NICE SORE THROAT CherryPHENOLLeosons Overseas Corp5f21694c-d1c9-0e64-e053-2a91aa0a0ff02024-11-15WarningsExact identifier
application number: M022
Sore ThroatPHENOLSafeway, Inc.f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d2024-11-14WarningsExact identifier
application number: M022
Sore Throat Relief CherryPHENOLBest Choice (Valu Merchandisers Company)c0a47d59-3e15-453d-97a7-d626e86508622024-11-14WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN7b7beec2-e070-4102-a2a4-68c332fc9fb35
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD7b7beec2-e070-4102-a2a4-68c332fc9fb35
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY7b7beec2-e070-4102-a2a4-68c332fc9fb35
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY7b7beec2-e070-4102-a2a4-68c332fc9fb35
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY7b7beec2-e070-4102-a2a4-68c332fc9fb35
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY7b7beec2-e070-4102-a2a4-68c332fc9fb35
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY7b7beec2-e070-4102-a2a4-68c332fc9fb35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72164-005-007216400050096 g in 1 TUBE (72164-005-00) 96 g2022-03-010000-00-00NoNoCurrent