Koala Kubs Diaper Rash Cream

Product NDC
54473-333
11-digit product format
544730333
Labeler code
54473
Product ID
54473-333_30ce75fa-69c6-932d-e063-6294a90a3a29
Type
HUMAN OTC DRUG
Nonproprietary name
Diaper Rash Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Melaleuca, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-09
Substance
ZINC OXIDE
Active strength
150 mg/88mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Koala Kubs Diaper Rash Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE150 mg/88mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-333-032025-04-07C16284748780-12cef2736-780f-d83d-e063-dadaa90ab31fKoala Kubs Diaper Rash Cream
54473-333-032025-01-30C16284748780-12cef2736-780f-d83d-e063-dadaa90ab31fKoala Kubs Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-333-03Koala Kubs Diaper Rash Cream88 mL in 1 TUBECREAM883

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-333KOALA KUBS DIAPER RASH CREAM (DIAPER RASH CREAM) CREAM [MELALEUCA, INC.]3Current NDC, Legacy NDC, 1 package rows20250409_c6b3b0dd-22a8-16f7-e053-2a95a90a51ea.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-333-035447303330388 mL in 1 TUBE (54473-333-03) 88 ml2021-07-090000-00-00NoNoCurrent