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.
| 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 |
|---|---|
| ZINC OXIDE | 150 mg/88mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c6b3b0dd-22a8-16f7-e053-2a95a90a51ea | Available on FDA.report |
DailyMed Product Concepts#
| 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 | 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 | 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| JAYSUING Hair Treatment Green Ginger | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2e8e70de-a2e0-7a71-e063-6294a90a90b8 | 2025-11-27 | Warnings | M016 |
| JAYSUING Liquid Wart Flat | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 3b0c05d1-a00e-97df-e063-6394a90af3d0 | 2025-11-27 | Warnings | M016 |
| JAYSUING 7 Days Nail Fungus Treatment | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2ef424cc-815a-b331-e063-6394a90aae70 | 2025-11-27 | Warnings | M016 |
| JAYSUING Pain Relief Knee Patches | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 358a3e81-abb5-0a65-e063-6294a90a3d69 | 2025-11-27 | Warnings | M016 |
| Sandra Plasencia PDRN Rejuvenating Serum | RH-OLIGOPEPTIDE-1 | Guangzhou Meijiao Medical Biotechnology Co., Ltd. | 449634c8-ff99-1387-e063-6294a90aef45 | 2025-11-27 | Warnings | M016 |
| GLUTATHIONE | KOJIC ACIDSKIN LIGHTENING | HANCHOYEANBIOTEC Co.,Ltd. | 2be274be-e6d0-d961-e063-6294a90a2190 | 2025-11-27 | Warnings | M016 |
| XIMONTH Bee Venom Joint Cream | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 33d18888-8d06-da13-e063-6294a90a743c | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Wart Remover Patch | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e6965b6-8f08-db62-e063-6394a90a64c9 | 2025-11-26 | Warnings | M016 |
| XIMONTH GLP-1 Patches | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3d03cdfd-2e9e-f9a1-e063-6394a90a6a8b | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Repair | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 37e40cc1-1121-1eee-e063-6294a90aab26 | 2025-11-26 | Warnings | M016 |
| XIMONTH Liquid Wart Corn Callus Remover | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3a1b872a-2883-0b70-e063-6294a90af9d6 | 2025-11-26 | Warnings | M016 |
| XIMONTH Jimerito Honey For Eyes | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3aa38704-4d2b-ffaf-e063-6294a90a323e | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Honey Eye Drops | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e69c950-bbbc-5c47-e063-6294a90a070e | 2025-11-26 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | 4c7e832e-55f3-4766-98b7-29b17d741a4b | 2025-11-26 | Warnings | M016 |
| Johnsons Baby Care Essentials Gift Set | ZINC OXIDE | Kenvue Brands LLC | 43edc287-57e1-d96e-e063-6294a90ac5a1 | 2025-11-24 | Warnings | M016 |
| Cetaphil Soothing Gel Cream | ALLANTOIN | Galderma Laboratories, L.P. | bab404f0-2f7a-4bac-b053-cbdc81c029b5 | 2025-11-24 | Warnings | M016 |
| health beyond VITAMINS AD | PETROLATUM | Nantong Health & Beyond Hygienic Products Inc. | de87da51-cf92-402c-b60f-5f28d1724124 | 2025-11-23 | Warnings | M016 |
| Medline | WHITE PETROLATUM | Medline Industries, LP | 00766a7b-797e-dd15-e063-6394a90af9ac | 2025-11-20 | Warnings | M016 |
| Itch Eraser Sensitive | SODIUM BICARBONATE | Tender Corporation d/b/a Adventure Ready Brands | 2250525a-45c2-42ea-e063-6394a90ac001 | 2025-11-18 | Warnings | M016 |
| Moisture Barrier Cream | PETROLATUM, ZINC OXIDE | Derma Sciences Canada Inc. | 43e01e22-7872-8e24-e063-6394a90a17ef | 2025-11-18 | Warnings | M016 |
Packages#
| 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 |