Home NDC 0135-1200 NATEAN
Product NDC 0135-1200
11-digit product format 001351200
Labeler code 0135
Product ID 0135-1200_1408ef2f-8220-6b90-e063-6394a90a1abc
Type HUMAN OTC DRUG
Nonproprietary name 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 SODIUM FLUORIDE
Active strength 1.5 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 and Whiten
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1044547 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 0135-1200-03 NATEANClean and Whiten 133 g in 1 TUBE PASTE 133 2 0135-1200-03 NATEANClean and Whiten 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 0135-1200 NATEAN CLEAN AND WHITEN (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 2 Current NDC, Legacy NDC, 2 package rows 20240321_71b95962-2693-49f5-94d2-f2a035b5e0c8.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 9 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 0135-1200-03 00135120003 1 TUBE in 1 CARTON (0135-1200-03) / 133 g in 1 TUBE 1 tube 2022-01-03 0000-00-00 No No Current