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 |
|---|---|---|---|---|---|---|
| ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me Cherry | LIP BALM SKIN PROTECTANT | Suave Brands Company | 47a2487d-b2e5-7195-e063-6394a90ae481 | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Cherry | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 4512b5a0-ce1f-c53e-e063-6294a90a56b6 | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Strawberry | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 42770fff-d70a-d9d1-e063-6294a90aa98d | 2026-03-30 | Warnings | M016 |
| Aveeno Skin Relief Healing | GLYCERIN | Kenvue Brands LLC | 345fdde5-700b-7103-e063-6394a90a0e3e | 2026-03-27 | Warnings | M016 |
| Critic Aid Clear | PETROLATUM | Coloplast Corp | 0b6da97e-519b-4579-9895-f4ede5c48b47 | 2026-03-27 | Warnings | M016 |
| Baza Protect | ZINC OXIDE AND DIMETHICONE | Coloplast Corp | 256dfcfc-a91c-49b0-9439-452586a0880e | 2026-03-27 | Warnings | M016 |
| Sween 24 | DIMETHICONE | Coloplast Corp | a623c8d7-8db0-410a-9980-02ac02f7b6ea | 2026-03-27 | Warnings | M016 |
| Baza Cleanse and Protect Odor Control | DIMETHICONE | Coloplast Corp | ca5fa4ae-c18d-4457-b520-4a9318ea821f | 2026-03-27 | Warnings | M016 |
| Baza Cleanse and Protect | DIMETHICONE | Coloplast Corp | 82eff041-0c9d-4261-a6b6-5a041a660074 | 2026-03-27 | Warnings | M016 |
| Baza Clear | PETROLATUM | Coloplast Corp | 69d9f456-1a35-4146-8366-c0285648a172 | 2026-03-27 | Warnings | M016 |
| Vitamin A D | LANOLIN, PETROLATUM | Topco Associates LLC | 5126fdf6-5df5-474b-bc0d-3a82dea61abb | 2026-03-26 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Amazon.com Services LLC | cdf1bd12-ac59-4f06-be0f-ef6eb3caeeff | 2026-03-26 | Warnings, Adverse reactions | M016 |
| Dynashield with Dimethicone | ZINC OXIDE | Dynarex Corporation | b5dcf9e8-4689-4a08-ae73-3a859b4cbffe | 2026-03-26 | Warnings | M016 |
| Eczema Relief Cream | COLLOIDAL OATMEAL | Lavior Pharma Inc | bdd2fc9f-2718-1d88-e053-2995a90a8682 | 2026-03-26 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 36f2dec8-7ffc-fc3e-e063-6294a90a76ff | 2026-03-26 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 36f33001-7fec-682e-e063-6394a90a9428 | 2026-03-26 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 36f3b300-f32f-8881-e063-6394a90a1a2a | 2026-03-26 | Warnings | M016 |
| White Petrolatum | PETROLATUM | Dynarex Corporation | 81f5092d-0632-bf47-e053-2991aa0ac563 | 2026-03-25 | Warnings | M016 |
| MYEVER | ESTRIOL CREAM | Hubei Redrui Building Materials Co., Ltd. | 3ed85485-a441-4c05-e063-6394a90afef5 | 2026-03-25 | Warnings | M016 |
| Softlips Peppermint Swirl | DIMETHICONE | The Mentholatum Company | 4dbea50e-d82d-c702-e063-6394a90ac6e4 | 2026-03-24 | 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 |