Durashield
- Product NDC
- 85131-013
- 11-digit product format
- 851310013
- Labeler code
- 85131
- Product ID
- 85131-013_b9f737e2-25dc-44cc-aa07-a5a77758473c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- benzalkonium chloride
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Advanced Biomedical Incorporated
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-18
- Substance
- BENZALKONIUM CHLORIDE
- Active strength
- .13 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
- Durashield
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZALKONIUM CHLORIDE | .13 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5UM2KM3W7 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85131-013-00 | Durashield | 0.33 mL in 1 BOTTLE | LOTION | 0.33 | | 1 |
| 85131-013-02 | Durashield | 60 mL in 1 BOTTLE | LOTION | 60 | | 1 |
| 85131-013-04 | Durashield | 118 mL in 1 BOTTLE | LOTION | 118 | | 1 |
| 85131-013-08 | Durashield | 237 mL in 1 BOTTLE, PUMP | LOTION | 237 | | 1 |
| 85131-013-12 | Durashield | 355 mL in 1 BOTTLE, PUMP | LOTION | 355 | | 1 |
| 85131-013-16 | Durashield | 473 mL in 1 BOTTLE, PUMP | LOTION | 473 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 85131-013 | DURASHIELD (BENZALKONIUM CHLORIDE) LOTION [ADVANCED BIOMEDICAL INCORPORATED] | 1 | Current NDC, 6 package rows | 20250116_b0723781-225a-46c6-907c-5c5c48f383b8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85131-013-00 | 85131001300 | .33 mL in 1 BOTTLE (85131-013-00) | | 2024-12-18 | No | No | Current |
| 85131-013-02 | 85131001302 | 60 mL in 1 BOTTLE (85131-013-02) | 60 ml | 2024-12-18 | No | No | Current |
| 85131-013-04 | 85131001304 | 118 mL in 1 BOTTLE (85131-013-04) | 118 ml | 2024-12-18 | No | No | Current |
| 85131-013-08 | 85131001308 | 237 mL in 1 BOTTLE, PUMP (85131-013-08) | 237 ml | 2024-12-18 | No | No | Current |
| 85131-013-12 | 85131001312 | 355 mL in 1 BOTTLE, PUMP (85131-013-12) | 355 ml | 2024-12-18 | No | No | Current |
| 85131-013-16 | 85131001316 | 473 mL in 1 BOTTLE, PUMP (85131-013-16) | 473 ml | 2024-12-18 | No | No | Current |