Peviderm Pramoxine Hydrocholride 1%
- Product NDC
- 58980-913
- 11-digit product format
- 589800913
- Labeler code
- 58980
- Product ID
- 58980-913_119ef16e-c873-41df-9e98-4ccade286a85
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pramoxine Hydrochloride
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Stratus Pharmaceuticals Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-11-01
- Substance
- PRAMOXINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Peviderm Pramoxine Hydrocholride 1%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRAMOXINE HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 88AYB867L5 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58980-913-80 | Peviderm Pramoxine Hydrocholride 1% | 222 mL in 1 BOTTLE | LOTION | 222 | | 2 |
| 58980-913-80 | Peviderm Pramoxine Hydrocholride 1% | 1 in 1 BOX | LOTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58980-913 | PEVIDERM PRAMOXINE HYDROCHOLRIDE 1% (PRAMOXINE HYDROCHLORIDE) LOTION [STRATUS PHARMACEUTICALS INC] | 2 | Current NDC, 2 package rows | 20241109_680b40fa-1922-443a-a4b0-7c3f6a2b847d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58980-913-80 | 58980091380 | 1 BOTTLE in 1 BOX (58980-913-80) / 222 mL in 1 BOTTLE | 1 bottle | 2024-11-01 | No | No | Current |