koala pals berrylicious

Generic: sodium fluoride

Labeler: melaleuca, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name koala pals berrylicious
Generic Name sodium fluoride
Labeler melaleuca, inc.
Dosage Form PASTE, DENTIFRICE
Routes
TOPICAL
Active Ingredients

sodium fluoride .2592 g/108g

Manufacturer
Melaleuca, Inc.

Identifiers & Regulatory

Product NDC 54473-300
Product ID 54473-300_4746e0a5-a9c5-c828-e063-6394a90ada98
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2010-04-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54473300
Hyphenated Format 54473-300

Supplemental Identifiers

RxCUI
416783
UNII
8ZYQ1474W7

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name koala pals berrylicious (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .2592 g/108g
source: ndc
Packaging
  • 108 g in 1 TUBE (54473-300-04)
source: ndc

Packages (1)

54473-300-04 108 g in 1 TUBE (54473-300-04)

Ingredients (1)

sodium fluoride (.2592 g/108g)

Linked Drug Pages (1)

Koala Pals Berrylicious ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4746e0a5-a9c5-c828-e063-6394a90ada98", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["416783"], "spl_set_id": ["6624be86-c9a8-53b8-e053-2a91aa0a87ef"], "manufacturer_name": ["Melaleuca, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "108 g in 1 TUBE (54473-300-04)", "package_ndc": "54473-300-04", "marketing_start_date": "20180101"}], "brand_name": "Koala Pals Berrylicious", "product_id": "54473-300_4746e0a5-a9c5-c828-e063-6394a90ada98", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "54473-300", "generic_name": "Sodium Fluoride", "labeler_name": "Melaleuca, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Koala Pals", "brand_name_suffix": "Berrylicious", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".2592 g/108g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20100401", "listing_expiration_date": "20261231"}