Sarna
- Product NDC
- 0316-0234
- 11-digit product format
- 003160234
- Labeler code
- 0316
- Product ID
- 0316-0234_483436b1-9031-4992-e063-6394a90ad0c5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pramoxine Hydrochloride, Menthol
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Crown Laboratories, Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-05
- Substance
- MENTHOL; PRAMOXINE HYDROCHLORIDE
- Active strength
- .5; 10 mg/1000mL; mg/1000mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sarna
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MENTHOL | .5 mg/1000mL |
| PRAMOXINE HYDROCHLORIDE | 10 mg/1000mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A, 88AYB867L5 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0316-0234-12 | Sarna | 355 mL in 1 BOTTLE, PUMP | LOTION | 355 | | 4 |
| 0316-0234-24 | Sarna | 5 mL in 1 PACKET | LOTION | 5 | | 4 |
| 0316-0234-75 | Sarna | 222 mL in 1 BOTTLE, PUMP | LOTION | 222 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0316-0234 | SARNA (PRAMOXINE HYDROCHLORIDE, MENTHOL) LOTION [CROWN LABORATORIES, INC] | 2 | Current NDC, 3 package rows | 20250323_19c41e75-a654-90cf-e063-6394a90a7e97.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0316-0234-12 | 00316023412 | 355 mL in 1 BOTTLE, PUMP (0316-0234-12) | 355 ml | 2024-01-05 | No | No | Current |
| 0316-0234-24 | 00316023424 | 5 mL in 1 PACKET (0316-0234-24) | 5 ml | 2024-03-13 | Yes | No | Current |
| 0316-0234-75 | 00316023475 | 222 mL in 1 BOTTLE, PUMP (0316-0234-75) | 222 ml | 2024-01-05 | No | No | Current |