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 13 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Calamine CALAMINE 8%, ZINC OXIDE 8% Farmacias De Similares TX LLC 4ecd0add-11c9-cf3b-e063-6394a90adff6 2026-04-06 Warnings Exact identifier application number: M016 Petroleum WHITE PETROLATUM CVS Pharmacy, Inc. 4dc08832-e610-4e62-a6af-cadaa339e39e 2026-04-06 Warnings, Adverse reactions Exact identifier application number: M016 Witch Hazel WITCH HAZEL SPRAY CVS Pharmacy 53db78a8-eb2d-431b-84c1-73e99bb9d3d1 2026-04-06 Warnings Exact identifier application number: M016 Petroleum WHITE PETROLATUM Amazon.com Services LLC 616ef87d-1518-46aa-8e12-9a1b678d4980 2026-04-06 Warnings, Adverse reactions Exact identifier application number: M016 Stabilizing Repair Serum OATMEAL Dermalogica, LLC. 86b7b230-5424-46d3-8058-656f5172fc70 2026-04-02 Warnings Exact identifier application number: M016 calamine CALAMINE AND ZINC OXIDE STRATEGIC SOURCING SERVICES 4e6a7bdf-4ef1-65e2-e063-6394a90ae124 2026-04-01 Warnings Exact identifier application number: M016 Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream COLLOIDAL OATMEAL Kenvue Brands LLC 4e4e1797-26e6-a67b-e063-6294a90af438 2026-03-31 Warnings Exact identifier application number: M016 Target Advanced Scar Gel ADVANCED SCAR GEL Target Corporation 86c215fe-aad4-45d1-bdb7-cde00a115c5c 2026-03-31 Warnings Exact identifier application number: M016 Zinc oxide, Dimethicone ZINC OXIDE, DIMETHICONE Walmart Inc. 4cbf9492-33cd-e6d4-e063-6294a90ab001 2026-03-31 Warnings, Adverse reactions Exact identifier application number: M016 Critic-Aid Clear PETROLATUM Coloplast Corp a92c18f7-52b2-43e4-bae3-2bab9de22671 2026-03-31 Warnings Exact identifier application number: M016 3M Cavilon Durable Barrier DIMETHICONE Solventum US LLC f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83 2026-03-31 Warnings Exact identifier application number: M016 XIMONTH Foot Sanitizer GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 4e38d24d-3745-c121-e063-6394a90abbb5 2026-03-30 Warnings Exact identifier application number: M016 Dynashield ZINC OXIDE Dynarex Corporation 59fd865c-b81d-43ad-8fa0-c37ca0557769 2026-03-30 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant COLLOIDAL OATMEAL Port Jervis Laboratories, Inc 4e43b65c-d5bb-f228-e063-6294a90ad08d 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Original SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4275956d-275a-4e31-e063-6394a90a78d3 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Cherry SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 42762471-e5cd-505e-e063-6294a90afb7d 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Variety Cherry-Strawberry-Spearmint SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 450e46d2-de86-e5fa-e063-6294a90ac6ff 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Original SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4512220a-9fc2-8816-e063-6394a90a9d15 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Original Military SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 45136b7e-136b-0283-e063-6394a90a599a 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic Spearmint SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4523af69-1a0d-6d18-e063-6394a90ad9d1 2026-03-30 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