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 |
|---|---|---|---|---|---|---|
| Skin Mercy Recovery Cream | COLLOIDAL OATMEAL | Cultskin Apothecary, Inc. | 4bac19f3-13bb-8d18-e063-6394a90aa393 | 2026-02-25 | Warnings | M016 |
| Skin Mercy Intense Recovery Cream | COLLOIDAL OATMEAL | Cultskin Apothecary, Inc. | 468f21c6-2d6f-1654-e063-6394a90ab2f5 | 2026-02-25 | Warnings | M016 |
| Magnet Eye Sheet Mask | EYE MASK | Guangdong Bisutang Biotechnology Co., LTD | 4a0a84d4-4024-5ea7-e063-6394a90a2b6c | 2026-02-24 | Warnings | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Family Dollar Stores, Inc | ac7da793-8a39-4b47-b075-a4c4820cadad | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Family Dollar Stores, Inc | 1a03331e-3676-451c-be22-9a547e8ae6e2 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Family Dollar Stores, Inc | 7e64a424-afdb-4eb9-b6af-7b8123f1e207 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | H E B | e6154e44-d7b2-429c-9bc7-5c064220d3fb | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | H E B | f0b31d52-2903-487a-aa70-0dbdf4c4d7e7 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | H E B | ff79e42c-da3f-4aec-acf4-cc26e10a1d08 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Dimethicone | DIMETHICONE | H E B | a8ad595a-c811-4534-82e0-9a01085b4b1e | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | H E B | ce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | H E B | 460802cc-c1b9-41cb-afe3-ca4078175efb | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | H E B | 2dd85211-0840-4d0d-8ba7-ea6184a50942 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Meijer, Inc. | 12867b23-b203-4bd7-af6d-efddeead26be | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | Meijer, Inc. | c7a4b7f2-4de9-470c-9f5b-0142bd935137 | 2026-02-24 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Better Living Brands, LLC | 75cb8f17-6ef2-403e-ab6e-d8e1e8168ec8 | 2026-02-23 | Warnings, Adverse reactions | M016 |
| WHITE PETROLATUM | PETROLATUM | Sion Biotext Medical Ltd | 53ca3aeb-1d5d-4964-adb5-1cfa901642da | 2026-02-23 | Warnings | M016 |
| Clear Anti Itch | PRAMOXINE HCL, ZINC ACETATE | Better Living Brands, LLC | 1d491635-9605-44fa-9860-ea23e4e8b21c | 2026-02-23 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Better Living Brands, LLC | ba50f2b2-aff8-42cd-8af0-369060a901fb | 2026-02-23 | Warnings, Adverse reactions | M016 |
| Oatmeal | DIMETHICONE | Better Living Brands, LLC | d28c5a60-0597-424f-bf7f-08dca39b22f5 | 2026-02-23 | 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 |