Diaper Rash Cream
- Product NDC
- 83369-002
- 11-digit product format
- 833690002
- Labeler code
- 83369
- Product ID
- 83369-002_4bd29285-29b5-5d57-e063-6294a90af481
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Smalls Brand LLC DBA Roe Wellness
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-02-27
- Substance
- ZINC OXIDE
- Active strength
- 15 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Diaper Rash Cream
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 15 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 245660 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4bd29285-29b4-5d57-e063-6294a90af481 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ef9a935e-31b7-402c-a66c-716cdfe4f126 | Product name | 9 | 20241218 |
| d1c9d1af-bddd-448d-86f7-69052b7d5b47 | Product name | 1 | 20220627 |
| 115c5bd2-98e1-4a98-8292-90803ca7e851 | Product name | 1 | 20220127 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83369-002-01 | Diaper Rash Cream | 85 g in 1 CARTON | CREAM | 85 | 1 |
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 |
|---|---|---|---|---|---|---|
| Calamine | FERRIC OXIDE RED | Perrigo Direct, Inc | 256bd1d4-fd50-408f-9aee-84f218bb4971 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Perrigo Direct, Inc | e11470b2-80d6-4008-b87e-eb6aeadfce74 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Perrigo Direct, Inc | cc0378f2-6d5f-47ec-b16a-64668b4c29cc | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXIND HCL | Perrigo Direct, Inc | 54a20ec9-ab86-4410-af94-e04393e9d4b3 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Vitamin A D | LANOLIN, PETROLATUM | Meijer, Inc. | adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Meijer, Inc. | 1b72f927-c2ae-4190-a035-5d7bb9f53c15 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Meijer, Inc. | af293cc0-ccd5-42a6-861b-c19fa6ffd06a | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Healing for Babies | PETROLATUM | Meijer, Inc. | 09878fe0-0890-4af3-a3f6-d2890041e9f8 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Meijer, Inc. | fa8ae34c-7b68-454f-8a3b-0eaa93a34092 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Baby Diaper Rash | ZINC OXIDE | Meijer, Inc. | 04bec667-a11e-42d2-a4b3-1416eebf1e8d | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Healing | PETROLATUM | Meijer, Inc. | 8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c1 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Meijer, Inc. | 6b369ef2-fd54-4931-a9eb-0fb42834c2ef | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Dimethicone | DIMETHICONE | Meijer, Inc. | 75b91b97-ea84-4c4d-9e58-5a9ff27a778c | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | Meijer, Inc. | d36a7479-7b3b-49fe-8144-b5cce0e173fb | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DAILY MOISTURIZING | Meijer, Inc. | 44949b46-70f2-4e52-adba-a8455da614eb | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Meijer, Inc. | 13e4aece-5b91-4f89-a912-540bf170a8d1 | 2026-02-19 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Target Corporation | 7fb5f9ca-cd90-4933-9fe8-907ece00458b | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Target Corporation | d4ee05c8-ae62-45df-8783-1ed57fa030ec | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Target Corporation | 5237c7f2-7135-4558-a758-4fc2a232172f | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Target Corporation | 3e620e4f-9e29-9e39-e063-6394a90adeda | 2026-02-18 | Warnings, Adverse reactions | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 245660 | zinc oxide 15 % Topical Cream | PSN | 4bd29285-29b4-5d57-e063-6294a90af481 | 1 |
| 245660 | zinc oxide 150 MG/ML Topical Cream | SCD | 4bd29285-29b4-5d57-e063-6294a90af481 | 1 |
| 245660 | zinc oxide 15 % Topical Cream | SY | 4bd29285-29b4-5d57-e063-6294a90af481 | 1 |
| 245660 | ZNO 150 MG/ML Topical Cream | SY | 4bd29285-29b4-5d57-e063-6294a90af481 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83369-002-01 | 83369000201 | 85 g in 1 CARTON (83369-002-01) | 85 g | 2026-02-27 | No | No | Current |