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 5 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fresh Scent PROTECTIVE BABY	ZINC OXIDE	CVS Pharmacy, Inc.	3f33c62c-43ec-4576-a24d-bd5de07e74d2	2026-07-23	Warnings	Exact identifier application number: M016
DERMFREE Vein Target Microneedle Patch	ALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57449e29-ec46-9c30-e063-6394a90a7b4a	2026-07-23	Warnings	Exact identifier application number: M016
Baby Vitamin A and D	LANOLIN 15.5%, PETROLATUM 53.4%	Walgreen Company	25a125ea-6f9f-310c-e063-6394a90acef2	2026-07-22	Warnings	Exact identifier application number: M016
First Aid A and D	LANOLIN 15.5%, PETROLATUM 53.4%	Walgreen Company	25a319d0-d39a-5ff0-e063-6394a90a671d	2026-07-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	57110309-9a3d-025f-e063-6394a90a015a	2026-07-22	Warnings	Exact identifier application number: M016
Dermasporin	LANOLIN	Marie's Original Formulas LLC	562f40aa-eeec-2b7c-e063-6294a90ad68d	2026-07-22	Warnings	Exact identifier application number: M016
CAREALL Vitamin A and D	PETROLATUM	New World Imports, Inc	ef89a68a-74c1-4c42-8078-b7a208ace0de	2026-07-22	Warnings	Exact identifier application number: M016
Dermact	LANOLIN	Marie's Original Formulas LLC	57121dbe-e886-a562-e063-6294a90a367f	2026-07-22	Warnings	Exact identifier application number: M016
Universal WITCH HAZEL	WITCH HAZEL	Universal Distribution Center LLC	7e0b56ef-fa41-4862-b387-5b58d81d67d4	2026-07-22	Warnings	Exact identifier application number: M016
Aveeno Soothing Bath Treatment	OATMEAL	Kenvue Brands LLC	0c410b8e-025f-477c-afac-6e2e9ac88f7d	2026-07-21	Warnings	Exact identifier application number: M016
DERMFREE SCAR SHEETS	SILICONE GEL 1% SCAR SHEETS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4ce316-4b92-7e81-e063-6294a90af6db	2026-07-21	Warnings	Exact identifier application number: M016
DERMFREE VARICOSE VEINS	DIMETHICONE 3% VARICOSE VEINS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5a2d1d-9e84-18eb-e063-6394a90a97ee	2026-07-21	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	571083ce-cd35-a638-e063-6394a90ae4c7	2026-07-20	Warnings	Exact identifier application number: M016
Mederma Stretch Marks Therapy	DIMETHICONE	PMI Branded Pharmaceuticals, Inc.	0f2918e3-9615-40e3-ab7e-6bfbe022e03c	2026-07-16	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Better Living Brands, LLC	c7ef0ef3-6861-4b94-af4b-371fee8c1f3d	2026-07-16	Warnings, Adverse reactions	Exact identifier application number: M016
Dove	MEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BAR	Conopco d/b/a Unilever	56bd6fcb-c762-4e5a-e063-6394a90a3438	2026-07-16	Warnings	Exact identifier application number: M016
Mederma Advanced Scar	ALLANTOIN	PMI Branded Pharmaceuticals, Inc.	25bc1eae-3502-4c63-bd8a-43be2dfb0d6d	2026-07-16	Warnings	Exact identifier application number: M016
Mederma Advanced Scar	ALLANTOIN	L. Perrigo Company	9c3d9e08-9428-4b28-82a2-0cb24c3c92a3	2026-07-16	Warnings	Exact identifier application number: M016
aftershave	CERAMIDE NP	Shengnan (Guangzhou) Cosmetics Co., LTD	56a17ac9-803b-932c-e063-6394a90aae90	2026-07-15	Warnings	Exact identifier application number: M016
Clear Root Labs Wound Care	CRL WOUND CARE OINTMENT	Aidance Scientific Inc. DBA Aidance Skincare & Topicals	56a6dbc7-5001-c095-e063-6294a90a1aa0	2026-07-15	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