Home NDC 54473-333 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 54473-333-03 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 54473-333-03 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 54473-333-03 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 54473-333-03 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54473-333-03 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54473-333-03 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54473-333-03 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 Kubs Diaper Rash Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 150 mg/88mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54473-333-03 Koala Kubs Diaper Rash Cream 88 mL in 1 TUBE CREAM 88 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-333 KOALA KUBS DIAPER RASH CREAM (DIAPER RASH CREAM) CREAM [MELALEUCA, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20250409_c6b3b0dd-22a8-16f7-e053-2a95a90a51ea.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 41 of 68 · 1,346 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Exemax Cream DIMETHICONE, ALLANTOIN PureTek Corporation 38e79055-df84-d314-e063-6394a90ac95f 2025-07-01 Warnings Exact identifier application number: M016 Procure Dimethicone 5% DIMETHICONE Twin Med LLC 38a7e4af-997d-549e-e063-6394a90a0bd6 2025-06-28 Warnings Exact identifier application number: M016 Zinc Oxide ZINC OXIDE OINTMENT Derma Sciences Canada Inc. 37eff762-1ea9-ec66-e063-6394a90a3d10 2025-06-19 Warnings Exact identifier application number: M016 Dr.Johnes SKIN TAG REMOVER SALICYLIC ACID Dr.Johnes LLC b731c55e-31ee-429f-8432-fac7c5718d83 2025-06-18 Warnings Exact identifier application number: M016 Dr. Johne SKIN TAG REMOVER SALICYLIC ACID Dr.Johnes LLC 6c5adc3c-9d45-449a-ad42-f9571851cd18 2025-06-18 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal OATMEAL THERAPLEX, LLC e51aa467-ffe7-4c6b-8588-6df8592596d4 2025-06-16 Warnings Exact identifier application number: M016 ZIIDII Wild Yam Cream WILD YAM Guangzhou Haishi Biological Technology Co., Ltd. 3733154a-4884-9988-e063-6294a90aa78c 2025-06-10 Warnings Exact identifier application number: M016 Aveeno Calm Plus Restore Skin Therapy Balm COLLOIDAL OATMEAL Kenvue Brands LLC dbe7a2cc-9c21-2a48-e053-2a95a90a54e2 2025-06-04 Warnings Exact identifier application number: M016 Petroleum Jelly WHITE PETROLATUM WALGREENS 2017113f-d192-5fbb-e063-6294a90a83b0 2025-05-31 Warnings Exact identifier application number: M016 AHHH Bite Relief SODIUM BICARBONATE 78271 25a1e070-9228-4ec9-e063-6294a90ad78d 2025-05-27 Warnings Exact identifier application number: M016 SupreH Bee Venom Skin Tag Treatment Liquid SUPREH BEE VENOM SKIN TAG REMOVER LIQUID Shenzhen Xinxin Yunhai Technology Co., Ltd. 35ca9836-917a-b0ac-e063-6294a90a28a2 2025-05-23 Warnings Exact identifier application number: M016 terrasil Diabetics Ulcer and Bed Sore Relief ALLANTOIN Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 35d2738c-dacf-7309-e063-6294a90aab4c 2025-05-23 Warnings Exact identifier application number: M016 terrasil Diabetics Ulcer and Sore Relief ALLANTOIN Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions fd6bf169-f1e2-48d4-b98d-8f3c39981a89 2025-05-23 Warnings Exact identifier application number: M016 Perfect 10 Soothing Recovery PETROLATUM Topiderm, Inc. e3a4f038-d084-4d77-bd35-13f41856a615 2025-04-30 Warnings Exact identifier application number: M016 Diabetic Advanced Healing Cream DIMETHICONE Neoteric Cosmetics, Inc. 46996845-9398-41d8-bf99-79f6a29bec28 2025-04-30 Warnings Exact identifier application number: M016 BabyDiaperCream BABY DIAPER CREAM Whole Foods Market d7b19529-d0b2-638b-e053-2a95a90acf2f 2025-04-29 Warnings Exact identifier application number: M016 ChapIce Moisture SPF 15 Lip Balm OXYBENZONE, OCTINOXATE, PETROLATUM Navajo Manufacturing Company Inc. 60ce1a8c-180a-161e-e053-2991aa0ae981 2025-04-29 Warnings Exact identifier application number: M016 Assurance Barrier Cream DIMETHICONE CREAM Walmart Inc 23a2a04f-71ce-4fa1-e063-6394a90a649e 2025-04-22 Warnings Exact identifier application number: M016 Aveeno Baby Eczema Therapy Moisturizing OATMEAL Kenvue Brands LLC 21d2c0a0-70c3-7fd3-e063-6394a90a46d4 2025-04-18 Warnings Exact identifier application number: M016 Secura Extra Protective ZINC OXIDE Smith & Nephew Medical Ltd 499a1944-1682-4798-9058-3748a5eaa420 2025-04-17 Warnings Exact identifier application number: M016
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54473-333-03 54473033303 88 mL in 1 TUBE (54473-333-03) 88 ml 2021-07-09 0000-00-00 No No Current