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 |
|---|---|---|---|---|---|---|
| EltaMD Laser Balm | PETROLATUM SKIN PROTECTANT | CP Skin Health Group, Inc | 1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb | 2023-11-09 | Warnings | M016 |
| DiaperDerm Diaper Rash | ZINC OXIDE | Diaperderm Inc | 4e1fce3e-c2b7-42da-9953-1dbb13e2467c | 2023-11-06 | Warnings | M016 |
| Doctors Diaper Rash Cream | ZINC OXIDE | DOCTOR'S DIAPER RASH CREAM, INC | 0988ccb1-7881-4d97-bcbf-d0cf4316e4be | 2023-11-06 | Warnings | M016 |
| DERMOIA Manuka Honey Eczema Cream | OATMEAL | TREASUREWISE LLC | a48e52a3-b681-4489-a1fd-6b09d8bc9c55 | 2023-11-06 | Warnings | M016 |
| GL HEALTH Barrier Skin Protectant | ZINC OXIDE | GL HEALTH, INC. | 76cfa330-fea9-48d4-b187-469154765d39 | 2023-11-06 | Warnings | M016 |
| Skin-lube | PETROLATUM, DIMETHICONE | The Hygenic Company, LLC. | d1005dec-04f6-3f88-e053-2a95a90ad9cb | 2023-11-05 | Warnings | M016 |
| Dr. Sheffield Anti Itch Cream | ANTI ITCH CREAM | Sheffield Pharmaceuticals LLC | 77f0593e-f694-4c02-9fd9-ad56ff2a920c | 2023-10-30 | Warnings | M016 |
| calahist | CALAMINE AND PRAMOXINE HYDROCHLORIDE | WALGREEN COMPANY | fed45e06-cc53-fbc5-e053-6294a90a1b19 | 2023-10-27 | Warnings | M016 |
| calahist clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | WALGREEN COMPANY | fed469c2-fe13-6726-e053-6394a90a5f51 | 2023-10-27 | Warnings | M016 |
| Dr. Sayman Salve | SALVE | Sheffield Pharmaceuticals LLC | 18bdcd0c-9c81-47e1-ae24-2239ff8fd066 | 2023-10-24 | Warnings | M016 |
| Theriac Advanced Healing | LANOLIN | Sheffield Pharmaceuticals LLC | c780cd27-dc9e-45f3-97f0-e59b1b6b955a | 2023-10-24 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash | ZINC OXIDE | Babo Botanicals, Inc. | d66e369e-9b19-b084-e053-2995a90aa259 | 2023-10-23 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Healing | COLLOIDAL OATMEAL | Babo Botanicals, Inc. | 08659a5c-2d10-2f98-e063-6394a90a7760 | 2023-10-23 | Warnings | M016 |
| White Rose Petroleum Jelly | PETROLATUM | J. Strickland & Co. | 1aeb090d-c103-4c2e-accc-d9d248315db9 | 2023-10-21 | Warnings | M016 |
| Tricalm Hydrogel | ALUMINUM ACETATE | MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES | 082c6441-be47-4466-e063-6394a90ad500 | 2023-10-20 | Warnings | M016 |
| Empower | WHITE PETROLATUM, ZINC OXIDE | Bemis Manufacturing Company Inc | 08006b60-966b-155b-e063-6294a90a206a | 2023-10-18 | Warnings | M016 |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | M016 |
| AnubisMed | SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA | ANUBIS COSMETICS SL | ebf4b3ab-34e1-185a-e053-2a95a90ace3a | 2023-09-05 | Warnings | M016 |
| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | DMAE | ANUBIS COSMETICS SL | f22b212d-d21d-5984-e053-2995a90a683e | 2023-09-01 | Warnings | 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 |