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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SUDOCREM SKIN PROTECTANT
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZINC OXIDE | 152.9 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SOI2LOH54Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84589-002 | SUDOCREM SKIN PROTECTANT (ZINC OXIDE) CREAM [LEDA INNOVATIONS USA, INC.] | 1 | Current NDC, 6 package rows | 20240830_20d2cf0b-d237-fd78-e063-6394a90a8d03.zip |
Packages#
Package NDC, 11-digit format, Description table| 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 | Historical |
| 84589-002-12 | 84589000212 | 125 g in 1 JAR (84589-002-12) | 125 g | 2024-08-06 | No | No | Historical |
| 84589-002-25 | 84589000225 | 250 g in 1 JAR (84589-002-25) | 250 g | 2024-08-06 | No | No | Historical |
| 84589-002-40 | 84589000240 | 400 g in 1 JAR (84589-002-40) | 400 g | 2024-08-06 | No | No | Historical |
| 84589-002-60 | 84589000260 | 60 g in 1 JAR (84589-002-60) | 60 g | 2024-08-06 | No | No | Historical |