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
Ingredient	Strength
POTASSIUM NITRATE	50 mg/g
SODIUM FLUORIDE	1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RU45X2JN0Z	Internal UNII lookup
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
7b7beec2-e070-4102-a2a4-68c332fc9fb3	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72164-005-00	Wintergreen Peppermint	96 g in 1 TUBE	PASTE, DENTIFRICE	96		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72164-005	WINTERGREEN PEPPERMINT (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [TWICE TWICE LLC]	4	Current NDC, Legacy NDC, 1 package rows	20250221_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 2 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ludens Watermelon Throat Drops	PECTIN	Prestige Brands Holdings, Inc.	adfb248a-96bb-4742-9df6-c47edccdd671	2026-08-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	584b38ce-d1ef-4ecc-a887-7c96e7f9669f	2026-08-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Walgreens	fb93c7f6-e025-4cf2-9997-acfe9a0debdd	2026-08-19	Warnings	Exact identifier application number: M022
CVS Saline	NASAL	CVS PHARMACY	f02c41b0-c78e-41cd-aa4a-2756bbe92087	2026-08-19	Warnings	Exact identifier application number: M022
Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	5965eb2a-1261-5258-e063-6294a90a7c2d	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Honey Licorice Throat Drops	MENTHOL	Prestige Brands Holdings, Inc.	5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Dual Relief	PECTIN AND MENTHOL	Prestige Brands Holdings, Inc.	d0213cb3-ec8e-40cc-82c9-694032f0490f	2026-08-19	Warnings	Exact identifier application number: M022
CVS Health Sore Throat Fast Relief Oral Anesthetic	PHENOL	CVS Pharmacy,Inc.	4fb880db-2185-41ef-a5f9-8983a28d2c5b	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Cherry	PHENOL	CVS Pharmacy,Inc.	887c68e0-ff44-4bad-b360-56fb99ed9c45	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Menthol Flavor	PHENOL	CVS PHARMACY,INC.	665be058-b965-4b78-80b0-dd8524180932	2026-08-17	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Harris Teeter, LLC	7e5f175d-f0d6-4665-ac14-1873d6b99c80	2026-08-12	Warnings	Exact identifier application number: M022
Gingicaine Gel Variety Pak	GINGICAINE GEL VARIETY PAK	Gingi-Pak a Division of the Belport	62ed4ff3-18f6-5c67-e053-2991aa0a7792	2026-08-11	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent ReadyInCase	HYDROGEN PEROXIDE	P & L Development, LLC	b0866db5-3b0d-4478-9b3b-1f077d2f5393	2026-08-06	Warnings	Exact identifier application number: M022
Ollie Fresh Mint	SODIUM FLUORIDE, POTASSIUM NITRATE	Brio Product Group LLC.	ebeec44f-3c22-43f2-9256-6ece6025c105	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	5868c5a1-273f-f023-e063-6394a90ac9d8	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58690bb5-9604-26a4-e063-6394a90afdbe	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586918cf-7b13-5999-e063-6294a90a88a9	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586924a0-322d-5dc3-e063-6294a90a1556	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58692e90-de74-52d3-e063-6394a90a9702	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586937ae-46af-7066-e063-6294a90ae53e	2026-08-06	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	7b7beec2-e070-4102-a2a4-68c332fc9fb3	5
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	7b7beec2-e070-4102-a2a4-68c332fc9fb3	5
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	7b7beec2-e070-4102-a2a4-68c332fc9fb3	5
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	7b7beec2-e070-4102-a2a4-68c332fc9fb3	5
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	7b7beec2-e070-4102-a2a4-68c332fc9fb3	5
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	7b7beec2-e070-4102-a2a4-68c332fc9fb3	5
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	7b7beec2-e070-4102-a2a4-68c332fc9fb3	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72164-005-00	72164000500	96 g in 1 TUBE (72164-005-00)	96 g	2022-03-01	0000-00-00	No	No	Current