NATEAN

Product NDC: 0135-1250
11-digit product format: 001351250
Labeler code: 0135
Product ID: 0135-1250_14084468-126f-1f14-e063-6394a90a9c69
Type: HUMAN OTC DRUG
Nonproprietary name: potassium nitrate, sodium fluoride
Dosage form: PASTE
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-01-03
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 50; 1.5 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: NATEAN
Brand name suffix: Clean plus Sensitivity Relief
Listing expiration: 2026-12-31

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
1086243	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
cea6f992-8a44-4eb8-baea-97b7b181b227	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0135-1250-01	NATEANClean plus Sensitivity Relief	133 g in 1 TUBE	PASTE	133		2
0135-1250-01	NATEANClean plus Sensitivity Relief	1 in 1 CARTON	PASTE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-1250	NATEAN CLEAN PLUS SENSITIVITY RELIEF (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]	2	Current NDC, Legacy NDC, 2 package rows	20240321_cea6f992-8a44-4eb8-baea-97b7b181b227.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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Iolite	BENZOCAINE	Dharma Research, Inc.	e4b2d22b-00b3-45a6-9b7d-8ee719587059	2023-10-09	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	a0e284f6-292f-4231-8596-f7cee4e0a12f	2023-10-09	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fe92637a-c88a-f9dd-e053-6294a90a7fa3	2023-07-01	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	c979e958-2042-471a-bf03-e84e68620106	2023-06-20	Warnings	Exact identifier application number: M022
Orajel Gum Pain 3X Medicated	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	9a1632ad-2b47-5653-e053-2995a90ae0d9	2023-01-20	Warnings	Exact identifier application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINT	BENZOCAINE	DMG AMERICA, LLC	0f90b227-f938-4e1a-a79e-1967b1a0477e	2021-10-01	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
1086243	potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste	PSN	cea6f992-8a44-4eb8-baea-97b7b181b227	2
1086243	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste	SCD	cea6f992-8a44-4eb8-baea-97b7b181b227	2
1086243	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste	SY	cea6f992-8a44-4eb8-baea-97b7b181b227	2
1086243	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste	SY	cea6f992-8a44-4eb8-baea-97b7b181b227	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-1250-01	00135125001	1 TUBE in 1 CARTON (0135-1250-01) / 133 g in 1 TUBE	1 tube	2022-01-03	0000-00-00	No	No	Current