Antibacterial Hand Cleanser
- Product NDC
- 50865-215
- 11-digit product format
- 508650215
- Labeler code
- 50865
- Product ID
- 50865-215_03fbe342-a3b7-9a63-e063-6294a90a15f2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzalkonium chloride
- Dosage form
- SOAP
- Route
- TOPICAL
- Labeler
- Kutol Products Company
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-08-17
- Substance
- BENZALKONIUM CHLORIDE
- Active strength
- .013 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
- Antibacterial Hand Cleanser
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZALKONIUM CHLORIDE | .013 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5UM2KM3W7 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50865-215-09 | Antibacterial Hand Cleanser | 3785 mL in 1 BOTTLE, PLASTIC | SOAP | 3785 | | 4 |
| 50865-215-12 | Antibacterial Hand Cleanser | 1200 mL in 1 BAG | SOAP | 1200 | | 4 |
| 50865-215-19 | Antibacterial Hand Cleanser | 237 mL in 1 BOTTLE, PUMP | SOAP | 237 | | 4 |
| 50865-215-65 | Antibacterial Hand Cleanser | 800 mL in 1 BAG | SOAP | 800 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50865-215 | ANTIBACTERIAL HAND CLEANSER (BENZALKONIUM CHLORIDE) SOAP [KUTOL PRODUCTS COMPANY] | 4 | Current NDC, Legacy NDC, 4 package rows | 20241220_56f50eda-5399-1bfe-e054-00144ff8d46c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50865-215-09 | 50865021509 | 3785 mL in 1 BOTTLE, PLASTIC (50865-215-09) | 3785 ml | 2017-08-17 | No | No | Historical |
| 50865-215-12 | 50865021512 | 1200 mL in 1 BAG (50865-215-12) | 1200 ml | 2017-08-17 | No | No | Historical |
| 50865-215-19 | 50865021519 | 237 mL in 1 BOTTLE, PUMP (50865-215-19) | 237 ml | 2017-08-17 | No | No | Historical |
| 50865-215-65 | 50865021565 | 800 mL in 1 BAG (50865-215-65) | 800 ml | 2017-08-17 | No | No | Historical |