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 |
|---|---|---|---|---|---|---|
| ZO Skin Health Post Procedure Program | ALUMINUM ACETATE | ZO Skin Health, Inc. | 9786acc8-06ae-4f2b-9602-b7e8c3baeca5 | 2024-11-12 | Warnings | M016 |
| DUKAL WHITE PETROLATUM | PETROLATUM | Dukal LLC | 0c6474ed-2343-d5f2-e063-6394a90a30b3 | 2024-11-12 | Warnings | M016 |
| CVS Health Advanced Scar Gel | ADVANCED SCAR GEL | CVS Health | 2fead2d8-b645-4d45-8e5b-b4f1da4e5a25 | 2024-11-12 | Warnings | M016 |
| CVS Health Advanced Scar Gel | ADVANCED SCAR GEL | CVS Health | c6926594-ad4e-4937-bda2-9311219a8881 | 2024-11-12 | Warnings | M016 |
| CVS Zinc Oxide | ZINC OXIDE | CVS Health | d67533b1-ae3f-4c9a-a6c9-a742290c90e9 | 2024-11-11 | Warnings | M016 |
| CVS Eczema Relief Skin Protectant | OATMEAL | CVS Health | 3cf25c43-592f-41cb-aa0b-a82f4e7faf3d | 2024-11-11 | Warnings | M016 |
| DGH Advanced Formula Scar Skin Protectant | ALLANTOIN | Dolgencorp Inc | 950dcffd-d2c3-4ca7-8a15-7cb1016ca364 | 2024-11-08 | Warnings | M016 |
| ABC Arbonne Baby Care Diaper Rash | DIMETHICONE AND ZINC OXIDE | Arbonne International, LLC | dd1d8198-bb9d-4508-a971-ae3bc624cdd1 | 2024-11-08 | Warnings | M016 |
| SUPER SENSITIVE DIAPER RASH | ZINC OXIDE | ORGANIC & SUSTAINABLE BEAUTY | b0de2a9b-7854-4caf-b7ff-632c1d4a382e | 2024-11-08 | Warnings | M016 |
| Dove | DERMASERIES ECZEMA RELIEF SOOTHING BODY LOTION | Conopco, Inc. d/b/a/ Unilever | bcfb12ea-304e-7d8c-e053-2a95a90af606 | 2024-11-07 | Warnings | M016 |
| Vaseline | CLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAM | Conopco, Inc. d/b/a/ Unilever | bd206830-e334-3764-e053-2995a90a74ca | 2024-11-07 | Warnings | M016 |
| Dove | MEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BAR | Conopco Inc. d/b/a/ Unilever | b9e61a03-e000-50ab-e053-2a95a90a3210 | 2024-11-07 | Warnings | M016 |
| Dove | DOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASH | Conopco Inc. d/b/a/ Unilever | b9f8cb31-560c-79e0-e053-2a95a90a39ae | 2024-11-07 | Warnings | M016 |
| Dove | CARE AND PROTECT ANTIBACTERIAL HAND WASH | Conopco Inc. d/b/a/ Unilever | ed234413-777a-9c82-e053-2a95a90a6f98 | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | CATCHING THE SUNRISE HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | b9fa6c72-7c56-6fd0-e053-2995a90a6707 | 2024-11-07 | Warnings | M016 |
| Dove | CARE AND PROTECT ANTIBACTERIAL FOAMING HAND WASH | Conopco Inc. d/b/a/ Unilever | ed24b320-27fc-9714-e053-2995a90a79a6 | 2024-11-07 | Warnings | M016 |
| SKINSEI | ETHYL ALCOHOL LIQUID | Conopco Inc. d/b/a/ Unilever | a603c419-238f-0bae-e053-2a95a90abc2b | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | UNDER THE STARLIT SKY HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0dfe52-c550-94fd-e053-2995a90a9800 | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | SUMMERTIME SPRINKLERS HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0e474c-db62-910f-e053-2995a90a889e | 2024-11-07 | Warnings | M016 |
| Find Your Happy Place | GIRLS NIGHT OUT HAND SANITIZER | Conopco Inc. d/b/a/ Unilever | ba0ce03e-5e7b-b09a-e053-2995a90a4eef | 2024-11-07 | 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 |