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 |
|---|---|---|---|---|---|---|
| UNIVERSAL BABY FRESH SCENT PETROLEUM | WHITE PETROLEUM | Universal Distribution Center LLC | ec67a1ee-ad71-54f2-e053-2995a90a7690 | 2026-01-29 | Warnings | M016 |
| Petroleum | WHITE PETROLATUM | 7-Select | 7e93df71-74bd-4d95-9a64-54756c7b234a | 2026-01-29 | Warnings, Adverse reactions | M016 |
| TheraCare Diabetic Foot Cream | DIMETHICONE, PETROLATUM | Veridian Healthcare | 49132a75-4a16-cede-e063-6294a90a6217 | 2026-01-29 | Warnings | M016 |
| TheraCare A and D | LANOLIN, PETROLATUM | Veridian Healthcare | 1303aa33-2111-b36c-e063-6294a90af131 | 2026-01-29 | Warnings | M016 |
| Zinc oxide | ZINC OXIDE | Aldi, Inc | d56782c1-b23c-47a9-82cb-d7dbb0ac7aa3 | 2026-01-29 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Aldi, Inc | 94fea2f2-fea8-4923-afc6-36068bc2fef5 | 2026-01-29 | Warnings, Adverse reactions | M016 |
| DAILY MOISTURIZING | DIMETHICONE LOTION | Aldi, Inc | 4ad18f4a-e148-4bf5-a04b-4168fa48eeb2 | 2026-01-29 | Warnings, Adverse reactions | M016 |
| Baby Eczema Therapy | COLLOIDAL OATMEAL | Aldi, Inc | 79f498af-c207-4f85-bf1b-fb2ee8379fd8 | 2026-01-29 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE | AMERISOURCE BERGEN | 90d9d908-57ea-4062-ade0-8a4888939c91 | 2026-01-29 | Warnings, Adverse reactions | M016 |
| UNIVERSAL LAVENDER SCENT PETROLEUM | WHITE PETROLEUM | Universal Distribution Center LLC | 066b1313-aed8-9436-e063-6294a90a2b11 | 2026-01-29 | Warnings | M016 |
| Equate Scar Topical | ALLANTOIN | WalMart | cf511a02-355c-4286-82fa-6f0c4a244823 | 2026-01-29 | Warnings | M016 |
| TriDerma Stubborn Diaper Rash Relief | ALLANTOIN, DIMETHICONE | Genuine Virgin Aloe Corporation | f8f3ae0b-aa55-4c2f-8823-54268524917b | 2026-01-28 | Warnings | M016 |
| Sunscreen SPF50 | NON NANO ZINC OXIDE | SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI | c5d52f13-a649-9579-e053-2a95a90a062c | 2026-01-27 | Warnings | M016 |
| Equate Chafing Gel | DIMETHICONE | Walmart Inc | 06665504-040c-a806-e063-6294a90acedc | 2026-01-27 | Warnings | M016 |
| Body Oil for Stretch Marks | HELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0IL | Dongguan Xiaogoubeige trading company Ltd. | 496af9a1-7249-622f-e063-6394a90aa284 | 2026-01-27 | Warnings | M016 |
| Herpecin L | ZINC OXIDE, DIMETHICONE | Focus Consumer Healthcare, LLC | 488a29c3-dd97-af1a-e063-6394a90aba7f | 2026-01-26 | Warnings | M016 |
| XIMONTH Nail Nourishing Pen | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 49451717-e41c-8ae0-e063-6294a90a91ad | 2026-01-26 | Warnings | M016 |
| Kerasal Athletes Foot Rapid Symptom Relief Medicated Soak | ALUMINUM SULFATE TETRADECAHYDRATE AND CALCIUM ACETATE MONOHYDRATE | Advantice Health, LLC. | 09a178c1-0eb1-43e5-bde8-fd27ed633d59 | 2026-01-26 | Warnings | M016 |
| VERADEX-E | PETROLATUM AND LANOLIN | ABBE Laboratories, Inc. | 00100102-c245-4b63-a4ff-794cacda6f17 | 2026-01-24 | Warnings | M016 |
| Hydrocortisone | DRS. HYDROCORTISONE | OL PHARMA TECH,LLC | b0eac8f3-bb80-6563-e053-2995a90a83c9 | 2026-01-22 | 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 |