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 |
|---|---|---|---|---|---|---|
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Old East Main Co. | 91df1434-bce6-4c6e-beee-cb5ec1cc8fff | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Old East Main Co. | cf916191-1de2-4305-b783-9e074c1ad94b | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Eczema Relief | COLLOIDAL OATMEAL | Old East Main Co. | b2dba027-c295-4a41-8d30-144904e1aa34 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Baby Eczema Therapy | COLLOIDAL OATMEAL | Old East Main Co. | 9720e2ad-1bcf-4023-8e92-22a962df3aad | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Chain Drug Marketing Association | 86ff4875-9007-4b7b-8f46-16cbd475d4bb | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Clear Anti-Itch | PRAMOXINE HCL, ZINC ACETATE | Chain Drug Marketing Association | 1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Chain Drug Marketing Association | 6c848b98-f01c-40f2-a9aa-2af76cb370c8 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | The Kroger Co. | fcffbe1f-79b8-451a-9384-19533b81d8c8 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | The Kroger Co. | d2095c7b-61ca-40d3-bbf1-04bed4dd789c | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | The Kroger Co. | ea8b186c-82d5-4552-bcce-03e56023ea99 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash Cream | ZINC OXIDE | Smalls Brand LLC DBA Roe Wellness | 4bd29285-29b4-5d57-e063-6294a90af481 | 2026-02-27 | Warnings | M016 83369-002 |
| Vitamin A D | LANOLIN, PETROLATUM | Walmart Inc. | 5893801a-25e1-4750-a55b-d9cddd3f1284 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Walmart Inc. | 320bcbd3-9e91-437f-99c5-066f880a4b32 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Skin Protectant | PETROLATUM | Walmart Inc. | eb836922-f467-42ab-a6e7-b787d97e6c17 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Walmart Inc. | aa7dbf7f-50be-475b-8140-68be3fa93507 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| White Petrolatum | WHITE PETROLATUM | Walmart Inc. | 176d7711-7c4f-4319-91af-0aba1260c412 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Soothing Moisturizing | COLLOIDAL OATMEAL | Walmart Inc. | 2d813455-c268-4c6d-9952-eaf0e0007d90 | 2026-02-27 | Warnings, Adverse reactions | M016 |
| Rapid Repair Healing Cream | ALLANTOIN, DIMETHICONE | June Jacobs Labs LLC | 186c13be-5e41-b9c9-e063-6294a90ad574 | 2026-02-26 | Warnings | M016 |
| Lanashield | LANOLIN | Dynarex Corporation | 94b277dc-6512-4d36-8485-8ea510097428 | 2026-02-26 | Warnings | M016 |
| GLADSKIN ECZEMACT ECZEMA | COLLOIDAL OATMEAL | Micreos North America, Inc. | 06f9af75-c5ff-d37b-e063-6394a90a4f6c | 2026-02-25 | Warnings | 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 |