SUDOCREM SKIN PROTECTANT
- Product NDC
- 84589-002
- 11-digit product format
- 845890002
- Labeler code
- 84589
- Product ID
- 84589-002_20d2cf0b-d236-fd78-e063-6394a90a8d03
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- LEDA INNOVATIONS USA, INC.
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-06
- Substance
- ZINC OXIDE
- Active strength
- 152.9 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- SUDOCREM SKIN PROTECTANT
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 152.9 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 20d2cf0b-d237-fd78-e063-6394a90a8d03 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84589-002-10 | SUDOCREM SKIN PROTECTANT | 1 in 1 BLISTER PACK | CREAM | 1 | 1 | |
| 84589-002-10 | SUDOCREM SKIN PROTECTANT | 10 g in 1 JAR | CREAM | 10 | 1 | |
| 84589-002-12 | SUDOCREM SKIN PROTECTANT | 125 g in 1 JAR | CREAM | 125 | 1 | |
| 84589-002-25 | SUDOCREM SKIN PROTECTANT | 250 g in 1 JAR | CREAM | 250 | 1 | |
| 84589-002-40 | SUDOCREM SKIN PROTECTANT | 400 g in 1 JAR | CREAM | 400 | 1 | |
| 84589-002-60 | SUDOCREM SKIN PROTECTANT | 60 g in 1 JAR | CREAM | 60 | 1 |
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 |
|---|---|---|---|---|---|---|
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84589-002-10 | 84589000210 | 1 JAR in 1 BLISTER PACK (84589-002-10) / 10 g in 1 JAR | 1 jar | 2024-08-06 | No | No | Current |
| 84589-002-12 | 84589000212 | 125 g in 1 JAR (84589-002-12) | 125 g | 2024-08-06 | No | No | Current |
| 84589-002-25 | 84589000225 | 250 g in 1 JAR (84589-002-25) | 250 g | 2024-08-06 | No | No | Current |
| 84589-002-40 | 84589000240 | 400 g in 1 JAR (84589-002-40) | 400 g | 2024-08-06 | No | No | Current |
| 84589-002-60 | 84589000260 | 60 g in 1 JAR (84589-002-60) | 60 g | 2024-08-06 | No | No | Current |