Home NDC 54473-300 Koala Pals
Product NDC 54473-300
11-digit product format 544730300
Labeler code 54473
Product ID 54473-300_4746e0a5-a9c5-c828-e063-6394a90ada98
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route TOPICAL
Labeler Melaleuca, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-04-01
Substance SODIUM FLUORIDE
Active strength .2592 g/108g
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 Koala Pals
Brand name suffix Berrylicious
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .2592 g/108g
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 54473-300-04 Koala PalsBerrylicious 108 g in 1 TUBE PASTE, DENTIFRICE 108 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-300 KOALA PALS BERRYLICIOUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [MELALEUCA, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20240831_6624be86-c9a8-53b8-e053-2a91aa0a87ef.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 50 · 995 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 54473-300-04 54473030004 108 g in 1 TUBE (54473-300-04) 108 g 2018-01-01 0000-00-00 No No Current