Guardelle
- Product NDC
- 85754-000
- 11-digit product format
- 857540000
- Labeler code
- 85754
- Product ID
- 85754-000_3a8774ed-4fdf-48b6-a54b-8db85492cb34
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BENZALKONIUM CHLORIDE
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Social Medical Supply LLC
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-16
- Substance
- BENZALKONIUM CHLORIDE
- Active strength
- .13 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guardelle
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZALKONIUM CHLORIDE | .13 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F5UM2KM3W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1020365 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8793e3be-7409-4f71-9397-abbeacd27cf8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85754-000-02 | Guardelle | 52 mL in 1 BOTTLE, PUMP | AEROSOL, FOAM | 52 | 1 | |
| 85754-000-07 | Guardelle | 207 mL in 1 BOTTLE, PUMP | AEROSOL, FOAM | 207 | 1 | |
| 85754-000-18 | Guardelle | 500 mL in 1 BOTTLE, PUMP | AEROSOL, FOAM | 500 | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BZK Antiseptic Wipe | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd | fe5eb694-4b1b-4c47-95d5-6074155c438a | 2023-11-09 | Warnings | M003 |
| Leader Alcohol 70 Isopropyl Alcohol | ISOPROPYL ALCOHOL | Cardinal Health | 4b5d50cb-a8b4-4997-a8dd-26506c4cdc6d | 2023-11-09 | Warnings | M003 |
| BZK Cleansing Swabsticks 4 Triple | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd | 52c74f75-d7ef-481b-b580-fba402d03d75 | 2023-11-09 | Warnings | M003 |
| MK Alcohol Swabstick Sterile | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd | 48d198f0-d505-4e45-b7c9-dd70658fd5fa | 2023-11-09 | Warnings | M003 |
| Maokang 3 Hydrogen Peroxide | HYDROGEN PEROXIDE | Changzhou Maokang Medical Products Co., Ltd | b4b478b9-426d-4864-a64c-31de9bbf5dc3 | 2023-11-09 | Warnings | M003 |
| MK Sting Relief Pads | BENZOCAINE, ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd | 1a60dd1b-0116-42a2-a501-4f74e326a2e9 | 2023-11-09 | Warnings | M003 |
| terrasil First Aid Antiseptic Wound and Burn Care Kit | HEXYLRESORCINOL | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 5ddb84e9-cdf7-4034-acd2-625f8d6e4601 | 2023-11-08 | Warnings | M003 |
| Inverness Ear Piercing | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | bcec8099-939b-4cff-b388-f4046164f2d4 | 2023-11-08 | Warnings | M003 |
| Hygienic Ear Care Antiseptic | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 98b70f22-cd53-e61b-e053-2995a90a730d | 2023-11-06 | Warnings | M003 |
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | Degasa, S.A. de C.V. | b4145aa4-d810-4c20-8493-311a7e222eb9 | 2023-11-05 | Warnings | M003 |
| HYDROGEN PEROXIDE | HYDROGEN PEROXIDE | DEGASA SA DE CV | 26bae595-6e76-4946-b98f-1aba2e69250d | 2023-11-05 | Warnings | M003 |
| Hand Sanitizer | ETHYL ALCOHOL | Raining Rose, Inc. | 416267f2-85c5-6633-e054-00144ff8d46c | 2023-11-03 | Warnings | M003 |
| Alcohol Prep Pads | 70%ISOPROPYL ALCOHOL | Raya Pharmaceuticals LLC | da108e12-4327-db1c-e053-2a95a90a211b | 2023-10-27 | Warnings | M003 |
| POVIDONE-IODINE PAD- povidone-iodine swab | POVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%) | Raya Pharmaceuticals LLC | dbcbd1be-5274-3de3-e053-2995a90abf1c | 2023-10-27 | Warnings | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Jianerkang Medical Co., Ltd | 4bfea435-f40d-4976-8450-a699f7640c65 | 2023-10-23 | Warnings | M003 |
| Sting Relief | BENZOCAINE, ISOPROPYL ALCOHOL | Jianerkang Medical Co., Ltd | 3a32398a-3f7e-4da0-bb1d-b3f369914b2a | 2023-10-23 | Warnings | M003 |
| Povidone Iodine Prep Pad | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | 47a504b8-b0c0-030a-e054-00144ff88e88 | 2023-10-23 | Warnings | M003 |
| Povidone Iodine Prep | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | 47a504b8-b0af-030a-e054-00144ff88e88 | 2023-10-23 | Warnings | M003 |
| BZK | BENZALKONIUM CHLORIDE | Jianerkang Medical Co., Ltd | d96c6ad2-c7e9-4079-9db2-59d108f284bb | 2023-10-23 | Warnings | M003 |
| Povidone Iodine Prep | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | 47a5690c-08bf-5092-e054-00144ff8d46c | 2023-10-23 | Warnings | M003 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1020365 | benzalkonium chloride 0.13 % Topical Foam | PSN | 8793e3be-7409-4f71-9397-abbeacd27cf8 | 1 |
| 1020365 | benzalkonium chloride 1.3 MG/ML Topical Foam | SCD | 8793e3be-7409-4f71-9397-abbeacd27cf8 | 1 |
| 1020365 | benzalkonium chloride 0.13 % Topical Foam | SY | 8793e3be-7409-4f71-9397-abbeacd27cf8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85754-000-02 | 85754000002 | 52 mL in 1 BOTTLE, PUMP (85754-000-02) | 52 ml | 2025-10-16 | No | No | Current |
| 85754-000-07 | 85754000007 | 207 mL in 1 BOTTLE, PUMP (85754-000-07) | 207 ml | 2025-10-16 | No | No | Current |
| 85754-000-18 | 85754000018 | 500 mL in 1 BOTTLE, PUMP (85754-000-18) | 500 ml | 2025-10-16 | No | No | Current |