Home NDC 83013-335 Hismile
Product NDC 83013-335
11-digit product format 830130335
Labeler code 83013
Product ID 83013-335_309366f8-6a53-fe9f-e063-6394a90a5de3
Type HUMAN OTC DRUG
Nonproprietary name Magically Delicious Flavor Sodium Fluoride Anticavity Toothpaste
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Hismile Pty Ltd
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-01
Substance SODIUM FLUORIDE
Active strength .243 g/100g
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 Hismile
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .243 g/100g
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 83013-335-06 Hismile 60 g in 1 BOTTLE, PUMP GEL, DENTIFRICE 60 1
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 50 · 995 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 83013-335-06 83013033506 60 g in 1 BOTTLE, PUMP (83013-335-06) 60 g 2025-06-01 No No Current