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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c6b3b0dd-22a8-16f7-e053-2a95a90a51ea	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-333-03	2025-04-07	C162847	48780-1	2cef2736-780f-d83d-e063-dadaa90ab31f	Koala Kubs Diaper Rash Cream
54473-333-03	2025-01-30	C162847	48780-1	2cef2736-780f-d83d-e063-dadaa90ab31f	Koala Kubs Diaper Rash Cream

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 15 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Softlips Vanilla	DIMETHICONE	The Mentholatum Company	56551008-a4e0-406f-8403-980d2e6b75a0	2026-03-24	Warnings	Exact identifier application number: M016
Selan Plus Zinc Oxide	SELAN PLUS ZINC OXIDE	Trividia Manufacturing Solutions, Inc	07396c61-1dfd-4be7-bddf-0eb570a18463	2026-03-24	Warnings	Exact identifier application number: M016
D-Cerin	MOISTURIZER	Dynarex Corporation	7ea47a7e-12af-9290-e053-2a91aa0a065f	2026-03-24	Warnings	Exact identifier application number: M016
MG217 Eczema Body	COLLOIDAL OATMEAL	Wisconsin Pharmacal Company	5f0cfd0c-ae87-f411-e053-2a91aa0ac251	2026-03-20	Warnings	Exact identifier application number: M016
Advanced Formula Scar Defense Cream	ALLANTOIN	Yantai Aien Biotechnology Co., Ltd.	4d5c70f9-da41-b535-e063-6294a90a73f2	2026-03-19	Warnings	Exact identifier application number: M016
TriplePaste Adult Care Rash Treatment	ZINC OXIDE	Advantice Health, LLC	2cf0575c-8d3d-1f16-e063-6294a90a629d	2026-03-19	Warnings	Exact identifier application number: M016
multipurpose	ZINC OXIDE SKIN PROTECTANT	Advantice Health, LLC	291563cc-7491-ce41-e063-6394a90ac6c1	2026-03-19	Warnings	Exact identifier application number: M016
Triple Diaper Rash	ZINC OXIDE	Advantice Health, LLC	d457c58d-8239-41c4-999e-d0ba237e3945	2026-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	f4464fb2-ba25-16f2-e053-2a95a90a0406	2026-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Cookie	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	fea4e5c7-780c-c7f4-e053-6294a90abb39	2026-03-19	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	4d46110b-5aa7-5261-e063-6394a90a423a	2026-03-18	Warnings	Exact identifier application number: M016
Advanced Bed Sore Wound Healing	ALLANTOIN	Yantai Aien Biotechnology Co., Ltd.	4d589c18-e597-355a-e063-6394a90a4243	2026-03-18	Warnings	Exact identifier application number: M016
MediChoice Barrier	DIMETHICONE	O&M HALYARD, INC.	115c2a2f-d68a-316a-e063-6394a90a2716	2026-03-17	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	4d4427b0-25c3-ddf6-e063-6394a90a6153	2026-03-17	Warnings	Exact identifier application number: M016
Colloidal Oatmeal	COLLOIDAL OATMEAL	Walmart Inc.	4a93f77d-41dc-3bab-e063-6394a90a804b	2026-03-16	Warnings, Adverse reactions	Exact identifier application number: M016
Vaseline	HEALING JELLY	Conopco Inc. d/b/a Unilever	bd4418b7-c6aa-5e71-e053-2995a90a4cc4	2026-03-16	Warnings	Exact identifier application number: M016
Vaseline Intensive Care Deep Moisture	PETROLEUM	Conopco Inc. d/b/a Unilever	65cec560-25c7-4076-a33d-a3dd534ff85b	2026-03-16	Warnings	Exact identifier application number: M016
Daily Moisturizing	DAILY MOISTRUIZING	Walgreen Co.	27452cc7-1ec6-4571-bcd0-0a7103735ee5	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M016
Tender Moments Delicate Baby Diaper Rash Balm	DIMETHICONE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	f09ba452-e1a6-4f45-901f-bb63d4f8e884	2026-03-13	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Body Skin Protectant	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	1a9d86fc-ef32-baed-e063-6394a90a7d74	2026-03-12	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

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