Home NDC 84035-005 Dentalclean Regenerator Sensitive Kids
Product NDC 84035-005
11-digit product format 840350005
Labeler code 84035
Product ID 84035-005_17f3172d-a323-6d68-e063-6394a90a1881
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride 0.24%
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Rabbit Ind�stria e Com�rcio de Produtos de Higiene Pessoal Ltda
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-01
Substance SODIUM FLUORIDE
Active strength 2.4 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 Dentalclean Regenerator Sensitive Kids
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 2.4 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 416783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84035-005-03 Dentalclean Regenerator Sensitive Kids 1 in 1 CARTON PASTE, DENTIFRICE 1 1 84035-005-03 Dentalclean Regenerator Sensitive Kids 104 g in 1 TUBE PASTE, DENTIFRICE 104 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84035-005 DENTALCLEAN REGENERATOR SENSITIVE KIDS (SODIUM FLUORIDE 0.24%) PASTE, DENTIFRICE [RABBIT INDÚSTRIA E COMÉRCIO DE PRODUTOS DE HIGIENE PESSOAL LTDA] 1 Current NDC, 2 package rows 20240601_17f31b5e-dd3b-78df-e063-6294a90a43ab.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 5 of 51 · 1,013 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84035-005-03 84035000503 1 TUBE in 1 CARTON (84035-005-03) / 104 g in 1 TUBE 1 tube 2024-06-01 No No Current