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

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
IngredientStrength
SODIUM FLUORIDE.2592 g/108g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-300-04Koala PalsBerrylicious108 g in 1 TUBEPASTE, DENTIFRICE1083

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-300KOALA PALS BERRYLICIOUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [MELALEUCA, INC.]2Current NDC, Legacy NDC, 1 package rows20240831_6624be86-c9a8-53b8-e053-2a91aa0a87ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN6624be86-c9a8-53b8-e053-2a91aa0a87ef3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD6624be86-c9a8-53b8-e053-2a91aa0a87ef3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY6624be86-c9a8-53b8-e053-2a91aa0a87ef3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY6624be86-c9a8-53b8-e053-2a91aa0a87ef3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY6624be86-c9a8-53b8-e053-2a91aa0a87ef3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-300-0454473030004108 g in 1 TUBE (54473-300-04) 108 g2018-01-010000-00-00NoNoCurrent