Home NDC 0135-1250 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.
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 27 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# 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