Benzalkonium Chloride
- Product NDC
- 55319-879
- 11-digit product format
- 553190879
- Labeler code
- 55319
- Product ID
- 55319-879_4a8e790e-8071-fa73-e063-6394a90a8a7a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzalkonium Chloride
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Family Dollar Stores, Inc
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-06-03
- Substance
- BENZALKONIUM CHLORIDE
- Active strength
- 1.3 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benzalkonium Chloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZALKONIUM CHLORIDE | 1.3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5UM2KM3W7 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55319-879-03 | Benzalkonium Chloride | 1470 mL in 1 BOTTLE, PLASTIC | GEL | 1470 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55319-879-03 | 55319087903 | 1470 mL in 1 BOTTLE, PLASTIC (55319-879-03) | 1470 ml | 2025-06-03 | No | No | Historical |