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 11 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dove	ANTIBACTERIAL CARE MOISTURIZING CREAM	Conopco Inc. d/b/a/ Unilever	5150f48c-ff0c-ce39-e063-6394a90ad424	2026-05-08	Warnings	Exact identifier application number: M016
Seedlings Diaper Rash Cream	ZINC OXIDE	Young Living Essential Oils, LC.	4d8aeaba-ddb1-6f74-e054-00144ff88e88	2026-05-08	Warnings	Exact identifier application number: M016
Nail Repairs Patches	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	5120b708-047a-1182-e063-6394a90a74c3	2026-05-06	Warnings	Exact identifier application number: M016
AOAO Acne Buster Salicylic Acid Drying Serum	ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.	Guangzhou Senmai Biotechnology Co.,Ltd.	512185a5-5c1d-ef9f-e063-6394a90a81af	2026-05-06	Warnings	Exact identifier application number: M016
AKOLKOL TOENAIL FUNGUS TREATMENT	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	5121c341-e5e9-2b36-e063-6394a90a93b8	2026-05-06	Warnings	Exact identifier application number: M016
Beyond Good Diaper Rash	ZINC OXIDE	Babylist, Inc	512b62df-4f08-d839-e063-6294a90ab52f	2026-05-06	Warnings	Exact identifier application number: M016
Acne Buster Salicylic Acid Drying Serum	ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.	Guangzhou Senmai Biotechnology Co.,Ltd.	4c531280-bc5b-1cf2-e063-6394a90a034a	2026-05-05	Warnings	Exact identifier application number: M016
PEGO Acne Buster Salicylic Acid Drying Serum	ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.	Guangzhou Senmai Biotechnology Co.,Ltd.	511eaced-c4d8-ae94-e063-6394a90a320e	2026-05-05	Warnings	Exact identifier application number: M016
Rugby Gas relief	SIMETHICONE	Rugby Laboratories	9b84f74f-8609-489d-b411-3103afa1b5c2	2026-05-04	Warnings	Exact identifier application number: M016
Vitamin A and D	PETROLATUM	Aldermed Inc.	3f13a15c-8b64-48f0-a459-853b9097bc31	2026-05-04	Warnings	Exact identifier application number: M016
Zinc Oxide Skin Protectant	ZINC OXIDE 20%	Aldermed Inc.	a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52	2026-05-04	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Aldermed Inc.	4e02af41-db86-46d8-a97d-332d84eced6f	2026-05-04	Warnings	Exact identifier application number: M016
Daily Moisturizer	LOTION	Walgreens	fc65f673-b23d-1ffa-e053-6394a90a0966	2026-05-03	Warnings	Exact identifier application number: M016
Dry Skin Healing	PETROLATUM	Walgreen	0397507d-4b6e-c679-e063-6294a90a0b33	2026-05-03	Warnings	Exact identifier application number: M016
Daily Moisturizer	LOTION	Walgreen	fc67037a-ed31-f678-e053-6394a90a7175	2026-05-03	Warnings	Exact identifier application number: M016
Skin Relief	LOTION	Walgreen	fc678e80-e63d-e3fe-e053-6394a90aa7d6	2026-05-03	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Walmart INC	f76ceecc-ef11-3839-e053-6394a90a8d4a	2026-05-03	Warnings	Exact identifier application number: M016
Herpecin L	DIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONE	Focus Consumer Healthcare, LLC	5b6ed4e9-3e69-c773-e053-2991aa0a7dfe	2026-05-01	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Retail Business Services, LLC	7291e175-a9b6-4c47-93ce-227ce11e4599	2026-04-30	Warnings, Adverse reactions	Exact identifier application number: M016
Herpecin Pain Relief	ALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCL	Focus Consumer Healthcare, LLC	beeb6043-6547-4fe9-e053-2995a90a5d74	2026-04-30	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